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UCLA Health: AI Platform Helps Uncover Promising Cancer Drug Combinations
LOS ANGELES, California, Oct. 22 (TNSjou) -- The UCLA Health issued the following news release:
* * *
New AI platform helps uncover promising cancer drug combinations
UCLA researchers combine large language models and 3D tumor testing to identify potential ways to overcome treatment resistance in prostate cancer
October 21, 2026
UCLA investigators have developed a new artificial intelligence-based platform that could help scientists identify promising drug combinations to overcome treatment resistance in cancer.
The platform, called MAESTRO and described in Advanced Science (https://advanced.onlinelibrary.wiley.com/doi/10.1002/advs.78186), ... Show Full Article LOS ANGELES, California, Oct. 22 (TNSjou) -- The UCLA Health issued the following news release: * * * New AI platform helps uncover promising cancer drug combinations UCLA researchers combine large language models and 3D tumor testing to identify potential ways to overcome treatment resistance in prostate cancer October 21, 2026 UCLA investigators have developed a new artificial intelligence-based platform that could help scientists identify promising drug combinations to overcome treatment resistance in cancer. The platform, called MAESTRO and described in Advanced Science (https://advanced.onlinelibrary.wiley.com/doi/10.1002/advs.78186),uses large language models, or LLMs, to analyze scientific knowledge about how drugs work and the biological pathways cancer cells use to survive treatment. The system evaluates potential drug combinations, ranks the most promising candidates and generates biological explanations that researchers can test in the laboratory.
To identify drugs that could help overcome treatment resistance in prostate cancer, the researchers used MAESTRO, short for Mechanistic Augmentation and Ensemble Selection for Therapeutic Ranking Optimization, to evaluate thousands of natural products. The platform identified several compounds that could potentially enhance the effectiveness of enzalutamide, a drug originally discovered and developed at UCLA that is commonly used to treat advanced prostate cancer.
"Developing drug combinations currently relies on either brute-force screening or researchers hypothesizing potential candidates based on existing literature," said Neil Lin, PhD, an associate professor of mechanical and aerospace engineering and bioengineering at the UCLA Samueli School of Engineering and senior author of the study. "It is time-consuming, and it can still be difficult to capture the complex interactions among multiple biological pathways. MAESTRO could substantially accelerate this process. By integrating existing biomedical knowledge, it can identify drug combinations that have a clear biological rationale and are most appropriate for experimental testing."
The researchers focused on prostate cancer, where treatment resistance remains a major challenge. Prostate cancer cells often depend on androgen receptor signaling to grow. Drugs such as enzalutamide work by blocking this signaling, but cancer cells can eventually adapt by activating alternative pathways that allow them to survive, leading to treatment resistance.
Combining drugs that target these escape routes could potentially help overcome resistance. However, with thousands of possible compounds and multiple interconnected biological pathways involved, identifying effective combinations remains a major challenge.
Although AI has shown promise in predicting drug combinations, many existing approaches require large amounts of experimental training data and provide limited insight into why certain drugs might work together. The UCLA team designed MAESTRO to address these limitations.
Researchers supplied the LLM with scientific information relevant to the task, including prostate cancer biology, resistance mechanisms and known drug actions. The model then evaluated how those mechanisms might interact with androgen receptor blockade and ranked compounds as potential partners for enzalutamide.
Rather than relying on a single prediction, the researchers had the model evaluate each candidate more than 100 times. They then looked at how highly each compound ranked and how consistent those rankings were across repeated evaluations. Compounds that consistently received high rankings were considered the most promising candidates.
The researchers used the platform to evaluate 3,592 natural products for their potential to work with enzalutamide. The system identified 150 high-confidence candidates for testing in 3D prostate cancer spheroids. These tumor-like clusters can better capture some aspects of cancer biology than cells grown in traditional flat layers. The researchers also supplemented the models with oxygen to reduce cell death caused by oxygen deprivation, allowing them to more accurately measure how the drug combinations affected cancer cells.
Of the 150 compounds tested, 23 showed evidence of synergy with enzalutamide, meaning the combination produced a greater effect than expected from the individual compounds. Further testing identified berberine, a naturally occurring compound found in several plants, as a particularly promising candidate. The combination of berberine and enzalutamide showed consistent synergy across four prostate cancer models with different mechanisms of treatment resistance.
"Berberine was not an obvious candidate because it affects several biological pathways, making it difficult to predict how it might work with other drugs," said James C.H. Lo, who was a postdoctoral student in the bioengineering department at UCLA when the work was conducted and first author of the study. "What surprised us was that the combination showed consistent synergy across all of the prostate cancer models, despite their different resistance mechanisms. This is where MAESTRO demonstrated its strength, helping us identify a promising combination that might have been overlooked by examining each pathway separately."
The researchers also investigated whether the biological effects of the combination matched the mechanism suggested by MAESTRO. They found that adding berberine to enzalutamide increased the activity of AMPK, a pathway involved in regulating cellular energy and stress, while suppressing mTORC1 signaling, which plays an important role in cell growth and survival. The combination was also associated with increased cellular stress and reduced DNA replication and cell-cycle progression.
The findings suggest that berberine and enzalutamide could be a promising combination for further research, particularly in prostate cancers that have developed resistance to treatment. The researchers also noted that the AMPK-mTORC1 mechanism identified in the study could help guide the development of other drug combinations designed to overcome resistance.
The researchers plan to further evaluate the combination in patient-derived tumor models and animal studies. They also hope to expand MAESTRO by incorporating additional types of biological data and applying the platform to other drug combinations, resistance mechanisms and cancer types.
"Large language models can be more than conversation or text-generation tools," said Lin, who holds a joint faculty appointment in urology at the David Geffen School of Medicine at UCLA and is an investigator at the UCLA Health Jonsson Comprehensive Cancer Center. "With appropriate scientific design and validation, they can support drug discovery and generate hypotheses that can be tested experimentally."
Other senior authors on the study include Robert Damoiseaux, PhD, professor of molecular and medical pharmacology and bioengineering and director of UCLA's Molecular Screening Shared Resource at the California NanoSystems Institute; Cho-Jui Hsieh, associate professor of computer science at the UCLA Samueli School of Engineering; Tanya Stoyanova, PhD, associate professor of molecular and medical pharmacology and urology at the David Geffen School of Medicine at UCLA; and Andrew Goldstein, PhD, professor of molecular, cell and developmental biology and urology at the David Geffen School of Medicine at UCLA.
Lin is also a member of the Broad Stem Cell Research Center, the California NanoSystems Institute and the Institute for Quantitative and Computational Biosciences at UCLA.
* * *
Original text here: https://www.uclahealth.org/news/release/new-ai-platform-helps-uncover-promising-cancer-drug
[Category: Medical]
* * *
New AI platform helps uncover promising cancer drug combinations
UCLA researchers combine large language models and 3D tumor testing to identify potential ways to overcome treatment resistance in prostate cancer
October 21, 2026
UCLA investigators have developed a new artificial intelligence-based platform that could help scientists identify promising drug combinations to overcome treatment resistance in cancer.
The platform, called MAESTRO and described in Advanced Science (https://advanced.onlinelibrary.wiley.com/doi/10.1002/advs.78186), ... Show Full Article LOS ANGELES, California, Oct. 22 (TNSjou) -- The UCLA Health issued the following news release: * * * New AI platform helps uncover promising cancer drug combinations UCLA researchers combine large language models and 3D tumor testing to identify potential ways to overcome treatment resistance in prostate cancer October 21, 2026 UCLA investigators have developed a new artificial intelligence-based platform that could help scientists identify promising drug combinations to overcome treatment resistance in cancer. The platform, called MAESTRO and described in Advanced Science (https://advanced.onlinelibrary.wiley.com/doi/10.1002/advs.78186),uses large language models, or LLMs, to analyze scientific knowledge about how drugs work and the biological pathways cancer cells use to survive treatment. The system evaluates potential drug combinations, ranks the most promising candidates and generates biological explanations that researchers can test in the laboratory.
To identify drugs that could help overcome treatment resistance in prostate cancer, the researchers used MAESTRO, short for Mechanistic Augmentation and Ensemble Selection for Therapeutic Ranking Optimization, to evaluate thousands of natural products. The platform identified several compounds that could potentially enhance the effectiveness of enzalutamide, a drug originally discovered and developed at UCLA that is commonly used to treat advanced prostate cancer.
"Developing drug combinations currently relies on either brute-force screening or researchers hypothesizing potential candidates based on existing literature," said Neil Lin, PhD, an associate professor of mechanical and aerospace engineering and bioengineering at the UCLA Samueli School of Engineering and senior author of the study. "It is time-consuming, and it can still be difficult to capture the complex interactions among multiple biological pathways. MAESTRO could substantially accelerate this process. By integrating existing biomedical knowledge, it can identify drug combinations that have a clear biological rationale and are most appropriate for experimental testing."
The researchers focused on prostate cancer, where treatment resistance remains a major challenge. Prostate cancer cells often depend on androgen receptor signaling to grow. Drugs such as enzalutamide work by blocking this signaling, but cancer cells can eventually adapt by activating alternative pathways that allow them to survive, leading to treatment resistance.
Combining drugs that target these escape routes could potentially help overcome resistance. However, with thousands of possible compounds and multiple interconnected biological pathways involved, identifying effective combinations remains a major challenge.
Although AI has shown promise in predicting drug combinations, many existing approaches require large amounts of experimental training data and provide limited insight into why certain drugs might work together. The UCLA team designed MAESTRO to address these limitations.
Researchers supplied the LLM with scientific information relevant to the task, including prostate cancer biology, resistance mechanisms and known drug actions. The model then evaluated how those mechanisms might interact with androgen receptor blockade and ranked compounds as potential partners for enzalutamide.
Rather than relying on a single prediction, the researchers had the model evaluate each candidate more than 100 times. They then looked at how highly each compound ranked and how consistent those rankings were across repeated evaluations. Compounds that consistently received high rankings were considered the most promising candidates.
The researchers used the platform to evaluate 3,592 natural products for their potential to work with enzalutamide. The system identified 150 high-confidence candidates for testing in 3D prostate cancer spheroids. These tumor-like clusters can better capture some aspects of cancer biology than cells grown in traditional flat layers. The researchers also supplemented the models with oxygen to reduce cell death caused by oxygen deprivation, allowing them to more accurately measure how the drug combinations affected cancer cells.
Of the 150 compounds tested, 23 showed evidence of synergy with enzalutamide, meaning the combination produced a greater effect than expected from the individual compounds. Further testing identified berberine, a naturally occurring compound found in several plants, as a particularly promising candidate. The combination of berberine and enzalutamide showed consistent synergy across four prostate cancer models with different mechanisms of treatment resistance.
"Berberine was not an obvious candidate because it affects several biological pathways, making it difficult to predict how it might work with other drugs," said James C.H. Lo, who was a postdoctoral student in the bioengineering department at UCLA when the work was conducted and first author of the study. "What surprised us was that the combination showed consistent synergy across all of the prostate cancer models, despite their different resistance mechanisms. This is where MAESTRO demonstrated its strength, helping us identify a promising combination that might have been overlooked by examining each pathway separately."
The researchers also investigated whether the biological effects of the combination matched the mechanism suggested by MAESTRO. They found that adding berberine to enzalutamide increased the activity of AMPK, a pathway involved in regulating cellular energy and stress, while suppressing mTORC1 signaling, which plays an important role in cell growth and survival. The combination was also associated with increased cellular stress and reduced DNA replication and cell-cycle progression.
The findings suggest that berberine and enzalutamide could be a promising combination for further research, particularly in prostate cancers that have developed resistance to treatment. The researchers also noted that the AMPK-mTORC1 mechanism identified in the study could help guide the development of other drug combinations designed to overcome resistance.
The researchers plan to further evaluate the combination in patient-derived tumor models and animal studies. They also hope to expand MAESTRO by incorporating additional types of biological data and applying the platform to other drug combinations, resistance mechanisms and cancer types.
"Large language models can be more than conversation or text-generation tools," said Lin, who holds a joint faculty appointment in urology at the David Geffen School of Medicine at UCLA and is an investigator at the UCLA Health Jonsson Comprehensive Cancer Center. "With appropriate scientific design and validation, they can support drug discovery and generate hypotheses that can be tested experimentally."
Other senior authors on the study include Robert Damoiseaux, PhD, professor of molecular and medical pharmacology and bioengineering and director of UCLA's Molecular Screening Shared Resource at the California NanoSystems Institute; Cho-Jui Hsieh, associate professor of computer science at the UCLA Samueli School of Engineering; Tanya Stoyanova, PhD, associate professor of molecular and medical pharmacology and urology at the David Geffen School of Medicine at UCLA; and Andrew Goldstein, PhD, professor of molecular, cell and developmental biology and urology at the David Geffen School of Medicine at UCLA.
Lin is also a member of the Broad Stem Cell Research Center, the California NanoSystems Institute and the Institute for Quantitative and Computational Biosciences at UCLA.
* * *
Original text here: https://www.uclahealth.org/news/release/new-ai-platform-helps-uncover-promising-cancer-drug
[Category: Medical]
OpenAI: Using Thousands of AI Agents to Uncover New Leads in Biological Data
SAN FRANCISCO, California, Oct. 22 (TNSjou) -- OpenAI, an Artificial Intelligence research and deployment company, issued the following news:
* * *
October 21, 2026
Using thousands of AI agents to uncover new leads in biological data
How OpenAI, PerturbAI, and Scripps Research used distributed AI agents to help scientists identify promising research leads in data from millions of brain cells
Read the paper (https://www.biorxiv.org/content/10.64898/2026.10.15.759436v1)
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What if scientists could uncover new clues about Alzheimer's and Parkinson's in minutes instead of months? Working together, ... Show Full Article SAN FRANCISCO, California, Oct. 22 (TNSjou) -- OpenAI, an Artificial Intelligence research and deployment company, issued the following news: * * * October 21, 2026 Using thousands of AI agents to uncover new leads in biological data How OpenAI, PerturbAI, and Scripps Research used distributed AI agents to help scientists identify promising research leads in data from millions of brain cells Read the paper (https://www.biorxiv.org/content/10.64898/2026.10.15.759436v1) - What if scientists could uncover new clues about Alzheimer's and Parkinson's in minutes instead of months? Working together,OpenAI, PerturbAI, and Scripps Research used thousands of AI agents powered by GPT Rosalind to analyze and interpret existing experimental data from millions of mouse brain cells in just 32 minutes. The agents connected the effects of gene disruptions with findings from scientific literature, uncovering unexpected biological connections that can help scientists understand disease and identify research directions for new treatments. The work shows how AI can help researchers explore more of what large biological experiments reveal.
Modern experiments generate far more data than scientists can thoroughly investigate. Researchers can now alter thousands of genes and measure their effects across millions of cells. But understanding what these results mean for human disease requires connecting complex experimental findings with decades of scattered scientific knowledge. This is where AI can help scientists uncover promising leads that might otherwise be missed.
* * *
"We build cell atlases so that other scientists can make discoveries we haven't imagined yet. AI could help more researchers explore these resources and turn unexpected observations into new questions to test."
-- Sarah Teichmann, Ph.D., Chair in Stem Cell Medicine at the University of Cambridge and founding co-chair of the Human Cell Atlas
* * *
The team divided the analysis among thousands of AI agents powered by GPT Rosalind, an approach we call distributed biological reasoning. The agents examined a whole-brain CRISPR atlas, a dataset showing how gene disruptions affect different types of cells across the mouse brain. Each agent investigated a gene disruption, analyzed cellular responses, searched scientific literature, and proposed explanations for the results. Their reports were combined into a reasoning atlas linking genes, cellular effects, relevant publications, and possible biological mechanisms.
The research team estimated that comparable human analysis and literature review, conducted one perturbation at a time, would take months to a year. The agents reproduced findings from human analyses while uncovering additional leads. Their assessments of novelty and scientific value also aligned with judgments from blinded human experts. These findings help prioritize further experiments needed to test the proposed biological mechanisms.
Some of these insights point to new leads for understanding brain disease. The agents identified unexpected differences in how two disease-linked genes affect brain cells differently, as well as a potential connection between cholesterol regulation and neurodegeneration. These findings could help scientists investigate how disease develops and where future treatments might intervene.
* * *
"Sometimes the clues are already there, scattered across different fields--we just haven't connected them. The possible link between neuronal function and cholesterol metabolism shows how those pieces, once brought together, can give us a new way to think about disease biology."
-- Tomasz Nowakowski, Ph.D., associate professor of neurological surgery at UCSF
* * *
Researchers can begin exploring these findings today. The reasoning atlas is available, allowing scientists to compare related genes, investigate unexpected responses, and identify promising leads to pursue. New discoveries often emerge when researchers from different fields bring their expertise together and connect familiar ideas in unexpected ways. AI can significantly scale these connections by linking new data with knowledge scattered across disciplines. The opportunity goes beyond analyzing data faster. By combining AI with experimental biology, human expertise, and scientific literature, we can help scientists turn more of their data into testable ideas.
Big experiments, unexpected clues
Some of an experiment's most interesting clues lie outside the story scientists set out to investigate. In a dataset spanning thousands of perturbations, those clues can be easy to miss.
The agents identified an unexpected difference between Tsc1 and Tsc2, two genes that work together to control mTOR, a major regulator of cell growth, metabolism, and aging. Disrupting either gene had similar effects in several groups of neurons. But in the cerebellum, which helps coordinate movement, Tsc2 disruption altered the activity of dozens of genes involved in neuronal communication, while Tsc1 disruption produced little change.
That difference may be relevant to human disease. In people with tuberous sclerosis, abnormalities in the cerebellum are strongly linked to TSC2 mutations. While medicines that reduce mTOR activity can treat certain brain tumors and seizures, learning and behavioral difficulties associated with the disease remain challenging to address. The agents pinpointed a specific group of neurons and cellular changes worth investigating: which changes might existing medicines correct, and which might point to new treatment approaches? This gives researchers a more specific set of questions to test in the lab.
Divide the work, deepen the reasoning
Could a single agent given the entire dataset do just as well as thousands of agents working in parallel? We tested this while keeping the model and resources fixed. As the workload grew, the single agent searched less of the literature, citing only 11 references at the largest workload, while the distributed agents cited more than 700 references. Human experts also preferred the distributed-agent interpretations.
Scientists have limited time and often focus on the strongest signals in their data. Distributed agents can help examine a wider range of responses, including subtle or unexpected ones, and connect them with relevant scientific literature. Running the agents in parallel allows many perturbations to be investigated at once. This helps scientists explore more of what an experiment contains and identify promising leads that might otherwise be missed.
Finding the next experiment worth doing
A finding becomes more valuable when it points to an experiment worth doing. The agents found one such lead in DCTN1, a gene whose mutations cause Perry syndrome, a neurodegenerative disease with Parkinson-like symptoms.
DCTN1 is involved in moving cargo inside neurons. In the whole-brain CRISPR atlas, disrupting Dctn1 increased the expression of genes involved in making cholesterol. The agents connected this observation with research suggesting that problems with cholesterol transport may cause cells to make more cholesterol. This raised a question for follow-up experiments: could DCTN1 disruption change how cholesterol is distributed within neurons, and could those changes contribute to neurodegeneration? If so, could restoring normal cholesterol distribution help protect neurons?
Human experts also considered this hypothesis novel, consequential and worth following up on. This example shows how connecting an unexpected result with existing knowledge can turn a clue into a testable idea, and potentially a new direction for treating disease.
Scientists remain at the center of discovery. By uncovering more promising leads, AI can help researchers decide which ideas to pursue, design experiments, and interpret results. The goal is to turn more of the information in biological experiments into knowledge that, over time, can help guide the development of better medicines.
* * *
Original text here: https://openai.com/index/scaling-ai-research-for-complex-biological-data/
[Category: BizComputer Technology]
* * *
October 21, 2026
Using thousands of AI agents to uncover new leads in biological data
How OpenAI, PerturbAI, and Scripps Research used distributed AI agents to help scientists identify promising research leads in data from millions of brain cells
Read the paper (https://www.biorxiv.org/content/10.64898/2026.10.15.759436v1)
-
What if scientists could uncover new clues about Alzheimer's and Parkinson's in minutes instead of months? Working together, ... Show Full Article SAN FRANCISCO, California, Oct. 22 (TNSjou) -- OpenAI, an Artificial Intelligence research and deployment company, issued the following news: * * * October 21, 2026 Using thousands of AI agents to uncover new leads in biological data How OpenAI, PerturbAI, and Scripps Research used distributed AI agents to help scientists identify promising research leads in data from millions of brain cells Read the paper (https://www.biorxiv.org/content/10.64898/2026.10.15.759436v1) - What if scientists could uncover new clues about Alzheimer's and Parkinson's in minutes instead of months? Working together,OpenAI, PerturbAI, and Scripps Research used thousands of AI agents powered by GPT Rosalind to analyze and interpret existing experimental data from millions of mouse brain cells in just 32 minutes. The agents connected the effects of gene disruptions with findings from scientific literature, uncovering unexpected biological connections that can help scientists understand disease and identify research directions for new treatments. The work shows how AI can help researchers explore more of what large biological experiments reveal.
Modern experiments generate far more data than scientists can thoroughly investigate. Researchers can now alter thousands of genes and measure their effects across millions of cells. But understanding what these results mean for human disease requires connecting complex experimental findings with decades of scattered scientific knowledge. This is where AI can help scientists uncover promising leads that might otherwise be missed.
* * *
"We build cell atlases so that other scientists can make discoveries we haven't imagined yet. AI could help more researchers explore these resources and turn unexpected observations into new questions to test."
-- Sarah Teichmann, Ph.D., Chair in Stem Cell Medicine at the University of Cambridge and founding co-chair of the Human Cell Atlas
* * *
The team divided the analysis among thousands of AI agents powered by GPT Rosalind, an approach we call distributed biological reasoning. The agents examined a whole-brain CRISPR atlas, a dataset showing how gene disruptions affect different types of cells across the mouse brain. Each agent investigated a gene disruption, analyzed cellular responses, searched scientific literature, and proposed explanations for the results. Their reports were combined into a reasoning atlas linking genes, cellular effects, relevant publications, and possible biological mechanisms.
The research team estimated that comparable human analysis and literature review, conducted one perturbation at a time, would take months to a year. The agents reproduced findings from human analyses while uncovering additional leads. Their assessments of novelty and scientific value also aligned with judgments from blinded human experts. These findings help prioritize further experiments needed to test the proposed biological mechanisms.
Some of these insights point to new leads for understanding brain disease. The agents identified unexpected differences in how two disease-linked genes affect brain cells differently, as well as a potential connection between cholesterol regulation and neurodegeneration. These findings could help scientists investigate how disease develops and where future treatments might intervene.
* * *
"Sometimes the clues are already there, scattered across different fields--we just haven't connected them. The possible link between neuronal function and cholesterol metabolism shows how those pieces, once brought together, can give us a new way to think about disease biology."
-- Tomasz Nowakowski, Ph.D., associate professor of neurological surgery at UCSF
* * *
Researchers can begin exploring these findings today. The reasoning atlas is available, allowing scientists to compare related genes, investigate unexpected responses, and identify promising leads to pursue. New discoveries often emerge when researchers from different fields bring their expertise together and connect familiar ideas in unexpected ways. AI can significantly scale these connections by linking new data with knowledge scattered across disciplines. The opportunity goes beyond analyzing data faster. By combining AI with experimental biology, human expertise, and scientific literature, we can help scientists turn more of their data into testable ideas.
Big experiments, unexpected clues
Some of an experiment's most interesting clues lie outside the story scientists set out to investigate. In a dataset spanning thousands of perturbations, those clues can be easy to miss.
The agents identified an unexpected difference between Tsc1 and Tsc2, two genes that work together to control mTOR, a major regulator of cell growth, metabolism, and aging. Disrupting either gene had similar effects in several groups of neurons. But in the cerebellum, which helps coordinate movement, Tsc2 disruption altered the activity of dozens of genes involved in neuronal communication, while Tsc1 disruption produced little change.
That difference may be relevant to human disease. In people with tuberous sclerosis, abnormalities in the cerebellum are strongly linked to TSC2 mutations. While medicines that reduce mTOR activity can treat certain brain tumors and seizures, learning and behavioral difficulties associated with the disease remain challenging to address. The agents pinpointed a specific group of neurons and cellular changes worth investigating: which changes might existing medicines correct, and which might point to new treatment approaches? This gives researchers a more specific set of questions to test in the lab.
Divide the work, deepen the reasoning
Could a single agent given the entire dataset do just as well as thousands of agents working in parallel? We tested this while keeping the model and resources fixed. As the workload grew, the single agent searched less of the literature, citing only 11 references at the largest workload, while the distributed agents cited more than 700 references. Human experts also preferred the distributed-agent interpretations.
Scientists have limited time and often focus on the strongest signals in their data. Distributed agents can help examine a wider range of responses, including subtle or unexpected ones, and connect them with relevant scientific literature. Running the agents in parallel allows many perturbations to be investigated at once. This helps scientists explore more of what an experiment contains and identify promising leads that might otherwise be missed.
Finding the next experiment worth doing
A finding becomes more valuable when it points to an experiment worth doing. The agents found one such lead in DCTN1, a gene whose mutations cause Perry syndrome, a neurodegenerative disease with Parkinson-like symptoms.
DCTN1 is involved in moving cargo inside neurons. In the whole-brain CRISPR atlas, disrupting Dctn1 increased the expression of genes involved in making cholesterol. The agents connected this observation with research suggesting that problems with cholesterol transport may cause cells to make more cholesterol. This raised a question for follow-up experiments: could DCTN1 disruption change how cholesterol is distributed within neurons, and could those changes contribute to neurodegeneration? If so, could restoring normal cholesterol distribution help protect neurons?
Human experts also considered this hypothesis novel, consequential and worth following up on. This example shows how connecting an unexpected result with existing knowledge can turn a clue into a testable idea, and potentially a new direction for treating disease.
Scientists remain at the center of discovery. By uncovering more promising leads, AI can help researchers decide which ideas to pursue, design experiments, and interpret results. The goal is to turn more of the information in biological experiments into knowledge that, over time, can help guide the development of better medicines.
* * *
Original text here: https://openai.com/index/scaling-ai-research-for-complex-biological-data/
[Category: BizComputer Technology]
Hilton Becomes First Major Hotel Brand to Offer Digital Solution to Pay With Points
MCLEAN, Virginia, Oct. 22 -- Hilton Worldwide Holdings posted the following news release:
* * *
Oct 21, 2026
Hilton Becomes First Major Hotel Brand to Offer Digital Solution to Pay with Points
* Pay with Points is a new Hilton Honors benefit that allows members to use Hilton Honors Points toward eligible hotel charges during Digital Check Out in the Hilton Honors App.
* Pay with Points is available to Hilton Honors members with Silver, Gold, Diamond or Diamond Reserve status at participating hotels in the U.S.
* Hilton is the first major hotel brand to offer Pay with Points through a fully ... Show Full Article MCLEAN, Virginia, Oct. 22 -- Hilton Worldwide Holdings posted the following news release: * * * Oct 21, 2026 Hilton Becomes First Major Hotel Brand to Offer Digital Solution to Pay with Points * Pay with Points is a new Hilton Honors benefit that allows members to use Hilton Honors Points toward eligible hotel charges during Digital Check Out in the Hilton Honors App. * Pay with Points is available to Hilton Honors members with Silver, Gold, Diamond or Diamond Reserve status at participating hotels in the U.S. * Hilton is the first major hotel brand to offer Pay with Points through a fullydigital check out experience with no front desk visit required.
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McLEAN, Va. - Hilton today launched Pay with Points, becoming the first major hotel brand to give members the opportunity to use loyalty Points toward their bill through a fully digital check out experience. The new Hilton Honors benefit enables members with Silver, Gold, Diamond or Diamond Reserve status to apply Points toward eligible hotel charges during Digital Check Out in the Hilton Honors App.
Pay with Points was created in direct response to Hilton Honors member feedback. According to recent Hilton research, 70% of Hilton Honors members surveyed are interested in using Points toward on-property purchases, and approximately half said the capability could make them more likely to stay or book with Hilton. Pay with Points brings flexibility into the digital stay experience, giving Hilton Honors members the ability to put their Points to work even before they leave the hotel.
Unlike comparable offerings that require front desk assistance, Pay with Points is completed by the guest, digitally, within the Hilton Honors App while at the hotel or on-the-go. During Digital Check Out, elite status members can now, for the first time, review their folio, choose from available Point redemption options and apply Points toward eligible charges.
"Loyalty is personal, and every Point a member earns represents a choice they made to stay with us," said Brad Anderson, vice president, Hilton Honors Program. "Our Hilton Honors members have told us they want more flexibility when it comes to using those Points. They can already redeem them for free night stays or money-can't-buy experiences around the world. Pay with Points introduces another digitally-enabled tool to our members, reducing the friction of travel and providing them with the choice and control that they value."
Enabled by Hilton's customized technology platform, Pay with Points is the latest example of how the company is bringing differentiated digital experiences to members faster and at scale, giving them greater flexibility and control throughout their journey. Pay with Points builds on Hilton's continued investment in digital tools that put members in control of their stay, including Digital Check In, Digital Key and Choose Your Room. With Points redemption now part of Digital Check Out in the Hilton Honors App, Hilton is making it easier for members to manage their stay experience from check in to check out.
Pay with Points is available now at 150 participating hotels in the U.S., reflecting Hilton's test-and-learn approach to evolving its digital experience. The benefit is expected to expand to more than 800 hotels by the end of 2026, followed by a full rollout to more than 6,000 participating properties in the U.S. and Canada in early 2027. Availability and eligible redemption options may vary by property.
* * *
FAQ: Hilton Becomes First Major Hotel Brand to Offer Digital Solution to Pay with Points
What is Pay with Points?
Pay with Points is a new Hilton Honors benefit that lets members use Hilton Honors Points toward eligible hotel charges during Digital Check Out in the Hilton Honors App.
Who is eligible for Pay with Points?
Pay with Points is available to Hilton Honors members with Silver, Gold, Diamond and Diamond Reserve status at participating hotels.
How does Pay with Points work?
During Digital Check Out in the Hilton Honors App, eligible members can review their folio, choose from available redemption options and apply Points toward the invoice. The experience is completed digitally with no front desk assistance required.
Where is Pay with Points available?
Pay with Points is available now at 150 participating hotels in the U.S. The benefit is expected to expand to more than 800 hotels by the end of 2026, followed by a full rollout to more than 6,000 participating properties in the U.S. and Canada in early 2027. Availability and eligible redemption options may vary by property.
How is Pay with Points different from other hotel loyalty offerings?
Hilton is the first major hotel brand to offer Pay with Points through a fully digital check out experience. Comparable offerings require front desk assistance, while Pay with Points is completed digitally in the Hilton Honors App.
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About Hilton
Hilton (NYSE: HLT) is a leading global hospitality company with a portfolio of 28 world-class brands comprising more than 9,400 properties and nearly 1.4 million rooms, in 144 countries and territories. Dedicated to fulfilling its founding vision to fill the earth with the light and warmth of hospitality, Hilton has welcomed over 4 billion guests in its more than 100-year history. Named as the No. 1 World's Best Workplace by Great Place to Work and Fortune, Hilton aims to create the best culture for its 500,000 team members around the world. Hilton has introduced industry-leading technology enhancements to improve the guest experience, including Digital Key Share, automated complimentary room upgrades and the ability to book confirmed connecting rooms. Through the award-winning guest loyalty program Hilton Honors, the more than 260 million Hilton Honors members who book directly with Hilton can earn Points for hotel stays and experiences money can't buy. With the free Hilton Honors app, guests can book their stay, select their room, check in, unlock their door with a Digital Key and check out, all from their smartphone. Visit stories.hilton.com for more information, and connect with Hilton on Facebook, X, LinkedIn, Instagram and YouTube.
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Original text here: https://stories.hilton.com/releases/hilton-becomes-first-major-hotel-brand-to-offer-digital-solution-to-pay-with-points
[Category: BizTravel]
* * *
Oct 21, 2026
Hilton Becomes First Major Hotel Brand to Offer Digital Solution to Pay with Points
* Pay with Points is a new Hilton Honors benefit that allows members to use Hilton Honors Points toward eligible hotel charges during Digital Check Out in the Hilton Honors App.
* Pay with Points is available to Hilton Honors members with Silver, Gold, Diamond or Diamond Reserve status at participating hotels in the U.S.
* Hilton is the first major hotel brand to offer Pay with Points through a fully ... Show Full Article MCLEAN, Virginia, Oct. 22 -- Hilton Worldwide Holdings posted the following news release: * * * Oct 21, 2026 Hilton Becomes First Major Hotel Brand to Offer Digital Solution to Pay with Points * Pay with Points is a new Hilton Honors benefit that allows members to use Hilton Honors Points toward eligible hotel charges during Digital Check Out in the Hilton Honors App. * Pay with Points is available to Hilton Honors members with Silver, Gold, Diamond or Diamond Reserve status at participating hotels in the U.S. * Hilton is the first major hotel brand to offer Pay with Points through a fullydigital check out experience with no front desk visit required.
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McLEAN, Va. - Hilton today launched Pay with Points, becoming the first major hotel brand to give members the opportunity to use loyalty Points toward their bill through a fully digital check out experience. The new Hilton Honors benefit enables members with Silver, Gold, Diamond or Diamond Reserve status to apply Points toward eligible hotel charges during Digital Check Out in the Hilton Honors App.
Pay with Points was created in direct response to Hilton Honors member feedback. According to recent Hilton research, 70% of Hilton Honors members surveyed are interested in using Points toward on-property purchases, and approximately half said the capability could make them more likely to stay or book with Hilton. Pay with Points brings flexibility into the digital stay experience, giving Hilton Honors members the ability to put their Points to work even before they leave the hotel.
Unlike comparable offerings that require front desk assistance, Pay with Points is completed by the guest, digitally, within the Hilton Honors App while at the hotel or on-the-go. During Digital Check Out, elite status members can now, for the first time, review their folio, choose from available Point redemption options and apply Points toward eligible charges.
"Loyalty is personal, and every Point a member earns represents a choice they made to stay with us," said Brad Anderson, vice president, Hilton Honors Program. "Our Hilton Honors members have told us they want more flexibility when it comes to using those Points. They can already redeem them for free night stays or money-can't-buy experiences around the world. Pay with Points introduces another digitally-enabled tool to our members, reducing the friction of travel and providing them with the choice and control that they value."
Enabled by Hilton's customized technology platform, Pay with Points is the latest example of how the company is bringing differentiated digital experiences to members faster and at scale, giving them greater flexibility and control throughout their journey. Pay with Points builds on Hilton's continued investment in digital tools that put members in control of their stay, including Digital Check In, Digital Key and Choose Your Room. With Points redemption now part of Digital Check Out in the Hilton Honors App, Hilton is making it easier for members to manage their stay experience from check in to check out.
Pay with Points is available now at 150 participating hotels in the U.S., reflecting Hilton's test-and-learn approach to evolving its digital experience. The benefit is expected to expand to more than 800 hotels by the end of 2026, followed by a full rollout to more than 6,000 participating properties in the U.S. and Canada in early 2027. Availability and eligible redemption options may vary by property.
* * *
FAQ: Hilton Becomes First Major Hotel Brand to Offer Digital Solution to Pay with Points
What is Pay with Points?
Pay with Points is a new Hilton Honors benefit that lets members use Hilton Honors Points toward eligible hotel charges during Digital Check Out in the Hilton Honors App.
Who is eligible for Pay with Points?
Pay with Points is available to Hilton Honors members with Silver, Gold, Diamond and Diamond Reserve status at participating hotels.
How does Pay with Points work?
During Digital Check Out in the Hilton Honors App, eligible members can review their folio, choose from available redemption options and apply Points toward the invoice. The experience is completed digitally with no front desk assistance required.
Where is Pay with Points available?
Pay with Points is available now at 150 participating hotels in the U.S. The benefit is expected to expand to more than 800 hotels by the end of 2026, followed by a full rollout to more than 6,000 participating properties in the U.S. and Canada in early 2027. Availability and eligible redemption options may vary by property.
How is Pay with Points different from other hotel loyalty offerings?
Hilton is the first major hotel brand to offer Pay with Points through a fully digital check out experience. Comparable offerings require front desk assistance, while Pay with Points is completed digitally in the Hilton Honors App.
* * *
About Hilton
Hilton (NYSE: HLT) is a leading global hospitality company with a portfolio of 28 world-class brands comprising more than 9,400 properties and nearly 1.4 million rooms, in 144 countries and territories. Dedicated to fulfilling its founding vision to fill the earth with the light and warmth of hospitality, Hilton has welcomed over 4 billion guests in its more than 100-year history. Named as the No. 1 World's Best Workplace by Great Place to Work and Fortune, Hilton aims to create the best culture for its 500,000 team members around the world. Hilton has introduced industry-leading technology enhancements to improve the guest experience, including Digital Key Share, automated complimentary room upgrades and the ability to book confirmed connecting rooms. Through the award-winning guest loyalty program Hilton Honors, the more than 260 million Hilton Honors members who book directly with Hilton can earn Points for hotel stays and experiences money can't buy. With the free Hilton Honors app, guests can book their stay, select their room, check in, unlock their door with a Digital Key and check out, all from their smartphone. Visit stories.hilton.com for more information, and connect with Hilton on Facebook, X, LinkedIn, Instagram and YouTube.
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Original text here: https://stories.hilton.com/releases/hilton-becomes-first-major-hotel-brand-to-offer-digital-solution-to-pay-with-points
[Category: BizTravel]
Hachette Book Group: PublicAffairs Announces One Day Free by Vladimir Kara-Murza
NEW YORK, Oct. 22 -- Hachette Book Group issued the following news release:
* * *
PublicAffairs announces One Day Free by Vladimir Kara-Murza
From Russian opposition leader and former political prisoner Vladimir Kara-Murza, the extraordinary account of his career, persecution, and resistance as Vladimir Putin transformed Russia from a flawed democracy to a full-fledged dictatorship
-
New York, NY (October 21, 2026)--PublicAffairs, an imprint of the Basic Books Group and the Hachette Book Group, announces the publication of ONE DAY FREE: A Personal History of Modern Russia and the Battle for ... Show Full Article NEW YORK, Oct. 22 -- Hachette Book Group issued the following news release: * * * PublicAffairs announces One Day Free by Vladimir Kara-Murza From Russian opposition leader and former political prisoner Vladimir Kara-Murza, the extraordinary account of his career, persecution, and resistance as Vladimir Putin transformed Russia from a flawed democracy to a full-fledged dictatorship - New York, NY (October 21, 2026)--PublicAffairs, an imprint of the Basic Books Group and the Hachette Book Group, announces the publication of ONE DAY FREE: A Personal History of Modern Russia and the Battle forIts Future by Vladimir Kara-Murza. "It is an honor to publish Vladimir's extraordinary book. His tireless efforts to stand up to authoritarian abuse have led to the passage of anti-corruption legislation around the globe, earned him a Pulitzer Prize--and nearly cost him his life. Vladimir's story is one of courageous dissent, perseverance, and an unwavering belief in the potential for a democratic Russia," says PublicAffairs' Editor in Chief Meagan Levinson. The book will go on sale on May 18, 2027, and is available for pre-order now.
"One Day Free is both a personal testimony and a historical chronicle--because, at a certain point, the two become inseparable. It is the story of a quarter-century of Vladimir Putin's rule over Russia with an honest look at those people, both in Russia and in the West, who strengthened and enabled it--and at those who fought it, sometimes at the price of their own lives," says Kara-Murza.
"In spite of everything, I am optimistic about Russia and its future. History knows many examples of once-terrifying tyrannies becoming peaceful civilized democracies--and no nation in the world is ever 'destined' to unfreedom. The day will come when Russia becomes a country that respects the rights of its own people and the borders of its neighbors. And, in this most important sense, the final chapters of this story are still unwritten."
In April 2022, Vladimir Kara-Murza was arrested and later sentenced to twenty-five years in a Russian penal colony for speaking out against the war in Ukraine and against Putin's dictatorship. He spent more than two years in prison--including eleven months of solitary confinement in Siberia--before he was released in the largest East-West prisoner exchange since the Cold War.
In this vivid memoir of post-Soviet Russia, Kara-Murza chronicles his and his compatriots' resistance to Putin's authoritarian takeover. Mentored by two of Putin's most prominent critics--opposition leader Boris Nemtsov and revered Soviet dissident Vladimir Bukovsky--Kara-Murza participated in some of the defining moments of modern Russia's history. He challenged Putin's party at the ballot box and saw firsthand how it stifles opponents. He rallied support from the streets of Moscow to the halls of the US Congress. And he paid the price for his defiance: He saw his friends murdered, narrowly escaped two poisonings, and was convicted of "high treason."
But Kara-Murza's hope for a democratic future in Russia remains undimmed. A tribute to resilience and courage in the face of oppression, ONE DAY FREE is a reminder that the darkness of authoritarianism must eventually give way to the light of freedom.
* * *
About the Author:
Vladimir Kara-Murza is a Russian opposition leader, former political prisoner, and laureate of the Vaclav Havel Human Rights Prize. Previously deputy leader of the People's Freedom Party and a candidate for the Russian parliament, he is a Pulitzer Prize-winning columnist at The Washington Post and holds an MA in history from the University of Cambridge.
* * *
About PublicAffairs:
Since its founding in 1997, PublicAffairs has been publishing prize-winning and bestselling works of serious non-fiction, with a focus on current affairs, public policy, foreign affairs, and technology. Drawing on deep expertise, our authors seek to educate and inform readers about the issues and events shaping the world today.
* * *
About Basic Books Group:
The Basic Books Group seeks to make the world smarter by publishing expert authors and enduring books. The group includes Basic Books, Seal Press, PublicAffairs, Bold Type Books, Basic Venture, and Basic Liberty.
* * *
About Hachette Book Group:
Hachette Book Group (HBG) is a leading U.S. general-interest book publisher made up of dozens of esteemed imprints within the publishing groups Basic Books Group, Grand Central Publishing Group, Hachette Audio, Little, Brown and Company, Little, Brown Books for Young Readers, Orbit, Workman Publishing, and Running Press Group. We also provide custom distribution, fulfillment, and sales services to several publishing companies.
Our books and authors have received the Pulitzer Prize, National Book Award, Caldecott Medal, Newbery Medal, Booker Prize, Nobel Prize, James Beard Award, and other major honors.
We are committed to diversity in our company and our publishing programs, and to fostering a culture of inclusion for all our employees and authors. We are proud to be part of Hachette Livre, the world's third-largest trade and educational publisher.
* * *
URL: PublicAffairs
URL: Basic Books Group
* * *
Original text here: https://www.hachettebookgroup.com/basic-books/publicaffairs-announces-one-day-free-by-vladimir-kara-murza/
* * *
PublicAffairs announces One Day Free by Vladimir Kara-Murza
From Russian opposition leader and former political prisoner Vladimir Kara-Murza, the extraordinary account of his career, persecution, and resistance as Vladimir Putin transformed Russia from a flawed democracy to a full-fledged dictatorship
-
New York, NY (October 21, 2026)--PublicAffairs, an imprint of the Basic Books Group and the Hachette Book Group, announces the publication of ONE DAY FREE: A Personal History of Modern Russia and the Battle for ... Show Full Article NEW YORK, Oct. 22 -- Hachette Book Group issued the following news release: * * * PublicAffairs announces One Day Free by Vladimir Kara-Murza From Russian opposition leader and former political prisoner Vladimir Kara-Murza, the extraordinary account of his career, persecution, and resistance as Vladimir Putin transformed Russia from a flawed democracy to a full-fledged dictatorship - New York, NY (October 21, 2026)--PublicAffairs, an imprint of the Basic Books Group and the Hachette Book Group, announces the publication of ONE DAY FREE: A Personal History of Modern Russia and the Battle forIts Future by Vladimir Kara-Murza. "It is an honor to publish Vladimir's extraordinary book. His tireless efforts to stand up to authoritarian abuse have led to the passage of anti-corruption legislation around the globe, earned him a Pulitzer Prize--and nearly cost him his life. Vladimir's story is one of courageous dissent, perseverance, and an unwavering belief in the potential for a democratic Russia," says PublicAffairs' Editor in Chief Meagan Levinson. The book will go on sale on May 18, 2027, and is available for pre-order now.
"One Day Free is both a personal testimony and a historical chronicle--because, at a certain point, the two become inseparable. It is the story of a quarter-century of Vladimir Putin's rule over Russia with an honest look at those people, both in Russia and in the West, who strengthened and enabled it--and at those who fought it, sometimes at the price of their own lives," says Kara-Murza.
"In spite of everything, I am optimistic about Russia and its future. History knows many examples of once-terrifying tyrannies becoming peaceful civilized democracies--and no nation in the world is ever 'destined' to unfreedom. The day will come when Russia becomes a country that respects the rights of its own people and the borders of its neighbors. And, in this most important sense, the final chapters of this story are still unwritten."
In April 2022, Vladimir Kara-Murza was arrested and later sentenced to twenty-five years in a Russian penal colony for speaking out against the war in Ukraine and against Putin's dictatorship. He spent more than two years in prison--including eleven months of solitary confinement in Siberia--before he was released in the largest East-West prisoner exchange since the Cold War.
In this vivid memoir of post-Soviet Russia, Kara-Murza chronicles his and his compatriots' resistance to Putin's authoritarian takeover. Mentored by two of Putin's most prominent critics--opposition leader Boris Nemtsov and revered Soviet dissident Vladimir Bukovsky--Kara-Murza participated in some of the defining moments of modern Russia's history. He challenged Putin's party at the ballot box and saw firsthand how it stifles opponents. He rallied support from the streets of Moscow to the halls of the US Congress. And he paid the price for his defiance: He saw his friends murdered, narrowly escaped two poisonings, and was convicted of "high treason."
But Kara-Murza's hope for a democratic future in Russia remains undimmed. A tribute to resilience and courage in the face of oppression, ONE DAY FREE is a reminder that the darkness of authoritarianism must eventually give way to the light of freedom.
* * *
About the Author:
Vladimir Kara-Murza is a Russian opposition leader, former political prisoner, and laureate of the Vaclav Havel Human Rights Prize. Previously deputy leader of the People's Freedom Party and a candidate for the Russian parliament, he is a Pulitzer Prize-winning columnist at The Washington Post and holds an MA in history from the University of Cambridge.
* * *
About PublicAffairs:
Since its founding in 1997, PublicAffairs has been publishing prize-winning and bestselling works of serious non-fiction, with a focus on current affairs, public policy, foreign affairs, and technology. Drawing on deep expertise, our authors seek to educate and inform readers about the issues and events shaping the world today.
* * *
About Basic Books Group:
The Basic Books Group seeks to make the world smarter by publishing expert authors and enduring books. The group includes Basic Books, Seal Press, PublicAffairs, Bold Type Books, Basic Venture, and Basic Liberty.
* * *
About Hachette Book Group:
Hachette Book Group (HBG) is a leading U.S. general-interest book publisher made up of dozens of esteemed imprints within the publishing groups Basic Books Group, Grand Central Publishing Group, Hachette Audio, Little, Brown and Company, Little, Brown Books for Young Readers, Orbit, Workman Publishing, and Running Press Group. We also provide custom distribution, fulfillment, and sales services to several publishing companies.
Our books and authors have received the Pulitzer Prize, National Book Award, Caldecott Medal, Newbery Medal, Booker Prize, Nobel Prize, James Beard Award, and other major honors.
We are committed to diversity in our company and our publishing programs, and to fostering a culture of inclusion for all our employees and authors. We are proud to be part of Hachette Livre, the world's third-largest trade and educational publisher.
* * *
URL: PublicAffairs
URL: Basic Books Group
* * *
Original text here: https://www.hachettebookgroup.com/basic-books/publicaffairs-announces-one-day-free-by-vladimir-kara-murza/
GE Aerospace's CF34 Engines to Power Aero-Dienst's New Air Ambulance Fleet
EVENDALE, Ohio, Oct. 22 -- GE Aerospace, a provider of jet and turboprop engines, as well as integrated systems for commercial, military, business and general aviation aircraft, posted the following news release:
* * *
GE Aerospace's CF34 Engines to Power Aero-Dienst's New Air Ambulance Fleet
LAS VEGAS - October 21 - GE Aerospace (NYSE: GE) today announced that Aero-Dienst has taken delivery of its first CF34 powered aircraft marking a milestone in the company's air ambulance fleet modernization. A second CF34 powered aircraft is expected to be delivered next year.
The new Challenger 650 aircraft ... Show Full Article EVENDALE, Ohio, Oct. 22 -- GE Aerospace, a provider of jet and turboprop engines, as well as integrated systems for commercial, military, business and general aviation aircraft, posted the following news release: * * * GE Aerospace's CF34 Engines to Power Aero-Dienst's New Air Ambulance Fleet LAS VEGAS - October 21 - GE Aerospace (NYSE: GE) today announced that Aero-Dienst has taken delivery of its first CF34 powered aircraft marking a milestone in the company's air ambulance fleet modernization. A second CF34 powered aircraft is expected to be delivered next year. The new Challenger 650 aircraftwill be modified into air ambulances post-delivery, strengthening Aero-Dienst's ability to perform medical transport missions.
Both aircraft will be covered by GE Aerospace's OnPoint support services program.
Sterling Leaven, General Manager of Business Aviation at GE Aerospace said, "Aero-Dienst's mission is vitally important, and we are proud to be underwing on their modernized fleet of air ambulances. Backed by our OnPoint services, these CF34 engines will power life-saving medical treatment and transportation across the world."
Aero-Dienst performs patient repatriation flights at the highest medical level, transporting over 1,000 patients annually from foreign countries back to Germany. During these often life-saving missions, its aircraft become flying intensive care units that carry experienced teams of doctors and paramedics, acting as the "university hospital of flight ambulances."
Aero-Dienst Managing Director, Dr. Oliver Kosing said, "Reliability isn't optional in air ambulance operations - it's essential. As the OEM, GE offers the fast, dependable service quality our mission requires, backed by GE Aerospace OnPoint's comprehensive coverage. That, combined with the strong partnership and consistently positive experience from our own maintenance teams over the years, made GE the clear choice for both of our new aircraft."
GE Aerospace's OnPoint solutions are customized service agreements tailored to the operational and financial needs of each airline customer. These agreements help lower the customers' cost of ownership and maximize the use of their assets. Backed by GE Aerospace's global support network, OnPoint services may include overhaul, on wing support, new and used serviceable parts, component repair, technology upgrades, engine leasing, integrated systems support and diagnostics and integrated systems.
* * *
About GE Aerospace
GE Aerospace is a global aerospace propulsion, services, and systems leader with an installed base of approximately 50,000 commercial and 30,000 military aircraft engines. With a global team of approximately 57,000 employees building on more than a century of innovation and learning, GE Aerospace is committed to inventing the future of flight, lifting people up, and bringing them home safely. Learn more about how GE Aerospace and its partners are defining flight for today, tomorrow, and the future at www.geaerospace.com.
* * *
About Aero-Dienst
Your Jet - Our Job - Since 1958.
With a 65-year track record in maintaining, operating, selling and managing a wide range of business and ambulance aircraft, Aero-Dienst is considered one of the leading business aviation companies in Europe. By employing more than 350 aviation professionals who focus on precision, reliability and absolute customer satisfaction, Aero-Dienst has earned a worldwide reputation for excellence in best-value-for-money aviation services - customer-focused, transparent and fair.
* * *
Original text here: https://www.geaerospace.com/news/press-releases/ge-aerospaces-cf34-engines-power-aero-diensts-new-air-ambulance-fleet
[Category: BizAerospace]
* * *
GE Aerospace's CF34 Engines to Power Aero-Dienst's New Air Ambulance Fleet
LAS VEGAS - October 21 - GE Aerospace (NYSE: GE) today announced that Aero-Dienst has taken delivery of its first CF34 powered aircraft marking a milestone in the company's air ambulance fleet modernization. A second CF34 powered aircraft is expected to be delivered next year.
The new Challenger 650 aircraft ... Show Full Article EVENDALE, Ohio, Oct. 22 -- GE Aerospace, a provider of jet and turboprop engines, as well as integrated systems for commercial, military, business and general aviation aircraft, posted the following news release: * * * GE Aerospace's CF34 Engines to Power Aero-Dienst's New Air Ambulance Fleet LAS VEGAS - October 21 - GE Aerospace (NYSE: GE) today announced that Aero-Dienst has taken delivery of its first CF34 powered aircraft marking a milestone in the company's air ambulance fleet modernization. A second CF34 powered aircraft is expected to be delivered next year. The new Challenger 650 aircraftwill be modified into air ambulances post-delivery, strengthening Aero-Dienst's ability to perform medical transport missions.
Both aircraft will be covered by GE Aerospace's OnPoint support services program.
Sterling Leaven, General Manager of Business Aviation at GE Aerospace said, "Aero-Dienst's mission is vitally important, and we are proud to be underwing on their modernized fleet of air ambulances. Backed by our OnPoint services, these CF34 engines will power life-saving medical treatment and transportation across the world."
Aero-Dienst performs patient repatriation flights at the highest medical level, transporting over 1,000 patients annually from foreign countries back to Germany. During these often life-saving missions, its aircraft become flying intensive care units that carry experienced teams of doctors and paramedics, acting as the "university hospital of flight ambulances."
Aero-Dienst Managing Director, Dr. Oliver Kosing said, "Reliability isn't optional in air ambulance operations - it's essential. As the OEM, GE offers the fast, dependable service quality our mission requires, backed by GE Aerospace OnPoint's comprehensive coverage. That, combined with the strong partnership and consistently positive experience from our own maintenance teams over the years, made GE the clear choice for both of our new aircraft."
GE Aerospace's OnPoint solutions are customized service agreements tailored to the operational and financial needs of each airline customer. These agreements help lower the customers' cost of ownership and maximize the use of their assets. Backed by GE Aerospace's global support network, OnPoint services may include overhaul, on wing support, new and used serviceable parts, component repair, technology upgrades, engine leasing, integrated systems support and diagnostics and integrated systems.
* * *
About GE Aerospace
GE Aerospace is a global aerospace propulsion, services, and systems leader with an installed base of approximately 50,000 commercial and 30,000 military aircraft engines. With a global team of approximately 57,000 employees building on more than a century of innovation and learning, GE Aerospace is committed to inventing the future of flight, lifting people up, and bringing them home safely. Learn more about how GE Aerospace and its partners are defining flight for today, tomorrow, and the future at www.geaerospace.com.
* * *
About Aero-Dienst
Your Jet - Our Job - Since 1958.
With a 65-year track record in maintaining, operating, selling and managing a wide range of business and ambulance aircraft, Aero-Dienst is considered one of the leading business aviation companies in Europe. By employing more than 350 aviation professionals who focus on precision, reliability and absolute customer satisfaction, Aero-Dienst has earned a worldwide reputation for excellence in best-value-for-money aviation services - customer-focused, transparent and fair.
* * *
Original text here: https://www.geaerospace.com/news/press-releases/ge-aerospaces-cf34-engines-power-aero-diensts-new-air-ambulance-fleet
[Category: BizAerospace]
Bracewell Earns 37 Rankings in IFLR1000 Western Europe 2027
HOUSTON, Texas, Oct. 22 -- Bracewell, a law firm, issued the following news release:
* * *
Bracewell Earns 37 Rankings in IFLR1000 Western Europe 2027
October 21, 2026
LONDON AND PARIS - Bracewell LLP earned 37 rankings in IFLR1000 Western Europe 2027, including eight practice and 29 individual rankings for banking, bank lending, M&A, project development and project finance in France and the UK.
IFLR1000 ranks financial and corporate law firms and lawyers around the world based on independent research, client feedback and market intelligence.
Bracewell's IFLR1000 Western Europe 2027 Rankings
France
Banking
* ... Show Full Article HOUSTON, Texas, Oct. 22 -- Bracewell, a law firm, issued the following news release: * * * Bracewell Earns 37 Rankings in IFLR1000 Western Europe 2027 October 21, 2026 LONDON AND PARIS - Bracewell LLP earned 37 rankings in IFLR1000 Western Europe 2027, including eight practice and 29 individual rankings for banking, bank lending, M&A, project development and project finance in France and the UK. IFLR1000 ranks financial and corporate law firms and lawyers around the world based on independent research, client feedback and market intelligence. Bracewell's IFLR1000 Western Europe 2027 Rankings France Banking *Anne Lapierre
Project Development
* Arnaud Belisaire
* Simon Cudennec
Project Development: Energy and Infrastructure (lawyer ranking only)
* Anne Lapierre
Project Finance (lawyer rankings only)
* Arnaud Belisaire
* Simon Cudennec
* Anne Lapierre
United Kingdom
Bank Lending: Borrower Side
* Olivia Caddy
* Jason Fox
* Eimear Murphy
Bank Lending: Lender Side (practice ranking only)
Banking (lawyer rankings only)
* Olivia Caddy
* Jason Fox
* Oliver Irwin
Corporate and M&A (lawyer ranking only)
* Francois Feuillat
Energy and Infrastructure (lawyer ranking only)
* Olivia Caddy
M&A (lawyer rankings only)
* Adam Blythe
* Nicholas Neuberger
* Darren Spalding
M&A: Large-Cap (practice ranking only)
M&A: Mid-Cap (practice ranking only)
Project Development
* Adam Blythe
* Ben James
* Ronen "Ro" Lazarovitch
Project Finance
* Olivia Caddy
* Jason Fox
* Oliver Irwin
* Ben James
* Tom Jamieson
* Ronen "Ro" Lazarovitch
* Gordon Stewart
Projects: Infrastructure (lawyer ranking only)
* Tom Jamieson
* * *
Original text here: https://www.bracewell.com/news-events/bracewell-earns-37-rankings-in-iflr1000-western-europe-2027/
[Category: BizLaw/Legal]
* * *
Bracewell Earns 37 Rankings in IFLR1000 Western Europe 2027
October 21, 2026
LONDON AND PARIS - Bracewell LLP earned 37 rankings in IFLR1000 Western Europe 2027, including eight practice and 29 individual rankings for banking, bank lending, M&A, project development and project finance in France and the UK.
IFLR1000 ranks financial and corporate law firms and lawyers around the world based on independent research, client feedback and market intelligence.
Bracewell's IFLR1000 Western Europe 2027 Rankings
France
Banking
* ... Show Full Article HOUSTON, Texas, Oct. 22 -- Bracewell, a law firm, issued the following news release: * * * Bracewell Earns 37 Rankings in IFLR1000 Western Europe 2027 October 21, 2026 LONDON AND PARIS - Bracewell LLP earned 37 rankings in IFLR1000 Western Europe 2027, including eight practice and 29 individual rankings for banking, bank lending, M&A, project development and project finance in France and the UK. IFLR1000 ranks financial and corporate law firms and lawyers around the world based on independent research, client feedback and market intelligence. Bracewell's IFLR1000 Western Europe 2027 Rankings France Banking *Anne Lapierre
Project Development
* Arnaud Belisaire
* Simon Cudennec
Project Development: Energy and Infrastructure (lawyer ranking only)
* Anne Lapierre
Project Finance (lawyer rankings only)
* Arnaud Belisaire
* Simon Cudennec
* Anne Lapierre
United Kingdom
Bank Lending: Borrower Side
* Olivia Caddy
* Jason Fox
* Eimear Murphy
Bank Lending: Lender Side (practice ranking only)
Banking (lawyer rankings only)
* Olivia Caddy
* Jason Fox
* Oliver Irwin
Corporate and M&A (lawyer ranking only)
* Francois Feuillat
Energy and Infrastructure (lawyer ranking only)
* Olivia Caddy
M&A (lawyer rankings only)
* Adam Blythe
* Nicholas Neuberger
* Darren Spalding
M&A: Large-Cap (practice ranking only)
M&A: Mid-Cap (practice ranking only)
Project Development
* Adam Blythe
* Ben James
* Ronen "Ro" Lazarovitch
Project Finance
* Olivia Caddy
* Jason Fox
* Oliver Irwin
* Ben James
* Tom Jamieson
* Ronen "Ro" Lazarovitch
* Gordon Stewart
Projects: Infrastructure (lawyer ranking only)
* Tom Jamieson
* * *
Original text here: https://www.bracewell.com/news-events/bracewell-earns-37-rankings-in-iflr1000-western-europe-2027/
[Category: BizLaw/Legal]
AstraZeneca: Ultomiris Received Accelerated Approval in the U.S. as First and Only C5 Complement Inhibitor to Reduce Proteinuria in Adults With Primary Immunoglobulin A Nephropathy
WILMINGTON, Delaware, Oct. 22 -- AstraZeneca, a biopharmaceutical company, issued the following news release:
* * *
ULTOMIRIS(R) (ravulizumab-cwvz) received accelerated approval in the US as first and only C5 complement inhibitor to reduce proteinuria in adults with primary immunoglobulin A nephropathy
21 October 2026
Based on I CAN Phase III trial results from prespecified interim analysis in which ULTOMIRIS demonstrated 43.4% reduction in proteinuria vs placebo at 34 weeks
Late-breaking results from I CAN Phase III trial will be presented at American Society of Nephrology's Kidney Week 2026
-
Alexion, ... Show Full Article WILMINGTON, Delaware, Oct. 22 -- AstraZeneca, a biopharmaceutical company, issued the following news release: * * * ULTOMIRIS(R) (ravulizumab-cwvz) received accelerated approval in the US as first and only C5 complement inhibitor to reduce proteinuria in adults with primary immunoglobulin A nephropathy 21 October 2026 Based on I CAN Phase III trial results from prespecified interim analysis in which ULTOMIRIS demonstrated 43.4% reduction in proteinuria vs placebo at 34 weeks Late-breaking results from I CAN Phase III trial will be presented at American Society of Nephrology's Kidney Week 2026 - Alexion,AstraZeneca Rare Disease's ULTOMIRIS(R) (ravulizumab-cwvz) has been approved in the US to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression.
This indication is approved under accelerated approval based on reduction of proteinuria. It has not been established whether ULTOMIRIS slows kidney function decline in patients with IgAN. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the ongoing I CAN Phase III trial evaluating ULTOMIRIS in adults with IgAN who are at risk of disease progression./1 The trial is ongoing and will assess the primary endpoint of change from baseline in estimated glomerular filtration rate (eGFR) at week 106, with data intended to support traditional FDA approval./2
The approval follows Priority Review by the US Food and Drug Administration (FDA) based on positive results from a prespecified interim analysis of the I CAN trial. Results showed ULTOMIRIS demonstrated a 43.4% reduction in proteinuria vs placebo at 34 weeks./3 ULTOMIRIS is administered intravenously every eight weeks in adults (based on body weight), following a loading dose./1
IgAN is a rare, inflammatory disease of the kidneys that can lead to chronic kidney disease and progress to end-stage kidney disease (ESKD). It begins when the body develops abnormal IgA proteins resulting in immune complexes that are deposited in the kidneys causing damage. The deposition of these complexes activates the complement system, leading to terminal complement-driven inflammation. This results in damage and loss of essential parts of the kidney, including cells in the glomeruli, the part of the kidneys that filters and cleans the blood./4 IgAN affects more than 200,000 people in the US./5,6 Approximately half of people with IgAN who have elevated protein levels in urine or reduced kidney function are at high risk of progression to ESKD, or kidney failure, within 10 years of diagnosis./7-9
Richard Lafayette, MD, Professor of Medicine (Nephrology) at the Stanford University Medical Center, Founder and Director of the Stanford Glomerular Disease Center and external scientific committee co-chair of the I CAN trial, said: "For many people living with IgAN, persistent proteinuria remains a significant challenge despite available treatments, signaling ongoing kidney injury and heightened risk of disease progression. With this approval of ULTOMIRIS, physicians now have a C5 inhibitor that delivers sustained terminal complement inhibition, targeting a central driver of kidney inflammation to meaningfully reduce proteinuria in patients living with this progressive disease."
Bonnie Schneider, Director & Co-Founder, IgA Nephropathy Foundation, said: "This approval reflects the importance of continued innovation to help improve outcomes for people living with IgAN. With its approved use across several other rare diseases and established safety profile, ULTOMIRIS provides a new treatment option in IgAN that gives patients - and their physicians - more choice as they navigate their care."
Marc Dunoyer, Chief Executive Officer, Alexion, said: "As the first and only C5 inhibitor approved for the reduction of proteinuria in adults with IgAN, ULTOMIRIS offers a new treatment option for people living with this serious disease. Many patients continue to face the risk of progression to kidney failure, underscoring the need for more targeted therapies that can slow the course of disease. This approval marks the fifth indication for ULTOMIRIS, building on Alexion's pioneering leadership across multiple complement-mediated rare diseases."
In the prespecified interim analysis from the I CAN Phase III trial, ULTOMIRIS demonstrated a 46.6% reduction in 24-hour urine protein creatinine ratio (UPCR) from baseline (95% confidence interval [CI]: 39.0%, 53.2%) at week 34, compared to 5.6% (95% CI: -4.9%, 15.0%) in patients receiving placebo, resulting in a placebo-adjusted treatment effect of 43.4% (95% CI: 33.5%, 51.8%; p<0.0001). The reduction in proteinuria was rapid, observed as early as week 10 with ULTOMIRIS (36.7% [95% CI: 30.2%, 42.6%]) and sustained through 34 weeks, compared to placebo (8.5% [95% CI: 0.5%, 15.8%]). These results were consistent across patient subgroups, reflecting diverse demographic and baseline clinical characteristics and disease severity.3
The safety profile observed in the trial was consistent with the known profile of ULTOMIRIS and was generally well tolerated, with no new safety concerns identified. Based on results from the prespecified interim analysis, the most common adverse events (AE) reported were upper respiratory tract infection (11.3%), nasopharyngitis (9.2%) and infusion-related reactions (8.4%) in those treated with ULTOMIRIS; and upper respiratory tract infection (10.2%), nasopharyngitis (9.0%) and hypertension (6.6%) in those receiving placebo./3
The interim results from the I CAN trial were presented at the 2026 European Renal Association (ERA) Congress, and late-breaking results will be presented at the American Society of Nephrology's Kidney Week on 23 October 2026./3,10
Regulatory submissions based on the interim results from the I CAN trial are also under review in Japan and additional countries.
INDICATIONS & IMPORTANT SAFETY INFORMATION for ULTOMIRIS(R) (ravulizumab-cwvz)
INDICATIONS
Paroxysmal Nocturnal Hemoglobinuria (PNH)
ULTOMIRIS is indicated for the treatment of adult and pediatric patients one month of age and older with paroxysmal nocturnal hemoglobinuria (PNH).
Atypical Hemolytic Uremic Syndrome (aHUS)
ULTOMIRIS is indicated for the treatment of adult and pediatric patients one month of age and older with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy (TMA).
Limitation of Use:
ULTOMIRIS is not indicated for the treatment of patients with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS).
Generalized Myasthenia Gravis (gMG)
ULTOMIRIS is indicated for the treatment of adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody-positive.
Neuromyelitis Optica Spectrum Disorder (NMOSD)
ULTOMIRIS is indicated for the treatment of adult patients with neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody positive.
Immunoglobulin A Nephropathy (IgAN)
ULTOMIRIS is indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression.
This indication is approved under accelerated approval based on reduction of proteinuria. It has not been established whether ULTOMIRIS slows kidney function decline in patients with IgAN. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory clinical trial.
IMPORTANT SAFETY INFORMATION
WARNING: SERIOUS MENINGOCOCCAL INFECTIONS
ULTOMIRIS, a complement inhibitor, increases the risk of serious infections caused by Neisseria meningitidis [see Warnings and Precautions (5.1)]. Life-threatening and fatal meningococcal infections have occurred in patients treated with complement inhibitors. These infections may become rapidly life-threatening or fatal if not recognized and treated early.
* Complete or update vaccination for meningococcal bacteria (for serogroups A, C, W, Y, and B) at least 2 weeks prior to the first dose of ULTOMIRIS, unless the risks of delaying ULTOMIRIS therapy outweigh the risk of developing a serious infection. Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for vaccinations against meningococcal bacteria in patients receiving a complement inhibitor. See Warnings and Precautions (5.1) for additional guidance on the management of the risk of serious infections caused by meningococcal bacteria.
* Patients receiving ULTOMIRIS are at increased risk for invasive disease caused by Neisseria meningitidis, even if they develop antibodies following vaccination. Monitor patients for early signs and symptoms of serious meningococcal infections and evaluate immediately if infection is suspected.
Because of the risk of serious meningococcal infections, ULTOMIRIS is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called ULTOMIRIS and SOLIRIS REMS [see Warnings and Precautions (5.2)].
CONTRAINDICATIONS
* Initiation in patients with unresolved serious Neisseria meningitidis infection.
WARNINGS AND PRECAUTIONS
Serious Meningococcal Infections
ULTOMIRIS, a complement inhibitor, increases a patient's susceptibility to serious, life-threatening, or fatal infections caused by meningococcal bacteria (septicemia and/or meningitis) in any serogroup, including non-groupable strains. Life-threatening and fatal meningococcal infections have occurred in both vaccinated and unvaccinated patients treated with complement inhibitors.
Revaccinate patients in accordance with ACIP recommendations considering the duration of ULTOMIRIS therapy. Note that ACIP recommends an administration schedule in patients receiving complement inhibitors that differs from the administration schedule in the vaccine prescribing information. If urgent ULTOMIRIS therapy is indicated in a patient who is not up to date with meningococcal vaccines according to ACIP recommendations, provide antibacterial drug prophylaxis and administer meningococcal vaccines as soon as possible. Various durations and regimens of antibacterial drug prophylaxis have been considered, but the optimal durations and drug regimens for prophylaxis and their efficacy have not been studied in unvaccinated or vaccinated patients receiving complement inhibitors, including ULTOMIRIS. The benefits and risks of treatment with ULTOMIRIS, as well as those associated with antibacterial drug prophylaxis in unvaccinated or vaccinated patients, must be considered against the known risks for serious infections caused by Neisseria meningitidis.
Vaccination does not eliminate the risk of serious meningococcal infections, despite development of antibodies following vaccination.
Closely monitor patients for early signs and symptoms of meningococcal infection and evaluate patients immediately if infection is suspected. Inform patients of these signs and symptoms and instruct patients to seek immediate medical care if they occur. Promptly treat known infections. Meningococcal infection may become rapidly life-threatening or fatal if not recognized and treated early. Consider interruption of ULTOMIRIS in patients who are undergoing treatment for serious meningococcal infection depending on the risks of interrupting treatment in the disease being treated.
ULTOMIRIS and SOLIRIS REMS
Due to the risk of serious meningococcal infections, ULTOMIRIS is available only through a restricted program called ULTOMIRIS and SOLIRIS REMS.
Prescribers must enroll in the REMS, counsel patients about the risk of serious meningococcal infection, provide patients with the REMS educational materials, assess patient vaccination status for meningococcal vaccines (against serogroups A, C, W, Y, and B) and vaccinate if needed according to current ACIP recommendations two weeks prior to the first dose of ULTOMIRIS. Antibacterial drug prophylaxis must be prescribed if treatment must be started urgently, and the patient is not up to date with both meningococcal vaccines according to current ACIP recommendations at least two weeks prior to the first dose of ULTOMIRIS. Patients must receive counseling about the need to receive meningococcal vaccines and to take antibiotics as directed, signs and symptoms of meningococcal infection, and be instructed to carry the Patient Safety Card at all times during and for 8 months following ULTOMIRIS treatment.
Further information is available at www.UltSolREMS.com or 1-888-765-4747.
Other Infections
Serious infections with Neisseria species (other than Neisseria meningitidis), including disseminated gonococcal infections, have been reported.
ULTOMIRIS blocks terminal complement activation; therefore, patients may have increased susceptibility to infections, especially with encapsulated bacteria, such as infections caused by Neisseria meningitidis but also Streptococcus pneumoniae, Haemophilus influenzae, and to a lesser extent, Neisseria gonorrhoeae. Children treated with ULTOMIRIS may be at increased risk of developing serious infections due to Streptococcus pneumoniae and Haemophilus influenzae type b (Hib). Administer vaccinations for the prevention of Streptococcus pneumoniae and Haemophilus influenzae type b (Hib) infections according to ACIP recommendations. Patients receiving ULTOMIRIS are at increased risk for infections due to these organisms, even if they develop antibodies following vaccination.
Monitoring Disease Manifestations after ULTOMIRIS Discontinuation
Treatment Discontinuation for PNH
After discontinuing treatment with ULTOMIRIS, closely monitor for signs and symptoms of hemolysis, identified by elevated LDH along with sudden decrease in PNH clone size or hemoglobin, or re-appearance of symptoms such as fatigue, hemoglobinuria, abdominal pain, shortness of breath (dyspnea), major adverse vascular event (including thrombosis), dysphagia, or erectile dysfunction. Monitor any patient who discontinues ULTOMIRIS for at least 16 weeks to detect hemolysis and other reactions. If signs and symptoms of hemolysis occur after discontinuation, including elevated LDH, consider restarting treatment with ULTOMIRIS.
Treatment Discontinuation for aHUS
ULTOMIRIS treatment of aHUS should be a minimum duration of 6 months. Due to heterogeneous nature of aHUS events and patient-specific risk factors, treatment duration beyond the initial 6 months should be individualized. There are no specific data on ULTOMIRIS discontinuation. After discontinuing treatment with ULTOMIRIS, patients should be monitored for clinical symptoms and laboratory signs of TMA complications for at least 12 months. TMA complications post-discontinuation can be identified if any of the following is observed: Clinical symptoms of TMA include changes in mental status, seizures, angina, dyspnea, thrombosis or increasing blood pressure. In addition, at least two of the following laboratory signs observed concurrently and results should be confirmed by a second measurement 28 days apart with no interruption: a decrease in platelet count of 25% or more as compared to either baseline or to peak platelet count during ULTOMIRIS treatment; an increase in serum creatinine of 25% or more as compared to baseline or to nadir during ULTOMIRIS treatment; or, an increase in serum LDH of 25% or more as compared to baseline or to nadir during ULTOMIRIS treatment. If TMA complications occur after discontinuation, consider reinitiation of ULTOMIRIS treatment or appropriate organ-specific supportive measures.
Thromboembolic Event Management
The effect of withdrawal of anticoagulant therapy during treatment with ULTOMIRIS has not been established. Treatment should not alter anticoagulant management.
Infusion-Related Reactions
Administration of ULTOMIRIS may result in systemic infusion-related reactions, including anaphylaxis and hypersensitivity reactions. In clinical trials, infusion-related reactions occurred in approximately 1 to 8% of patients, including lower back pain, abdominal pain, muscle spasms, drop or elevation in blood pressure, rigors, limb discomfort, drug hypersensitivity (allergic reaction), and dysgeusia (bad taste). These reactions did not require discontinuation of ULTOMIRIS. If signs of cardiovascular instability or respiratory compromise occur, interrupt ULTOMIRIS and institute appropriate supportive measures.
ADVERSE REACTIONS
Adverse Reactions for PNH
Adverse reactions reported in 10% or more of patients with PNH were upper respiratory tract infection and headache. Serious adverse reactions were reported in 15 (6.8%) patients receiving ULTOMIRIS. The serious adverse reactions in patients treated with ULTOMIRIS included hyperthermia and pyrexia. No serious adverse reaction was reported in more than 1 patient treated with ULTOMIRIS. One fatal case of sepsis was identified in a patient treated with ULTOMIRIS. In clinical studies, clinically relevant adverse reactions in 1% of adult patients include infusion-related reactions.
Adverse reactions reported in 10% of pediatric patients treated with ULTOMIRIS who were treatment-naive vs eculizumab-experienced were anemia (20% vs 25%), abdominal pain (0% vs 38%), constipation (0% vs 25%), pyrexia (20% vs 13%), upper respiratory tract infection (20% vs 75%), pain in extremity (0% vs 25%), and headache (20% vs 25%).
Adverse Reactions for aHUS
Most common adverse reactions in patients with aHUS (incidence 20%) were upper respiratory tract infection, diarrhea, nausea, vomiting, headache, hypertension and pyrexia. Serious adverse reactions were reported in 42 (57%) patients with aHUS receiving ULTOMIRIS. The most frequent serious adverse reactions reported in more than 2 patients (2.7%) treated with ULTOMIRIS were hypertension, pneumonia and abdominal pain.
Adverse reactions reported in 20% of pediatric patients treated with ULTOMIRIS were diarrhea, constipation, vomiting, pyrexia, upper respiratory tract infection, decreased vitamin D, headache, cough, rash, and hypertension.
Adverse Reactions for gMG
Most common adverse reactions in adult patients with gMG (incidence 10%) were diarrhea and upper respiratory tract infection. Serious adverse reactions were reported in 20 (23%) of patients treated with ULTOMIRIS and in 14 (16%) patients receiving placebo. The most frequent serious adverse reactions were infections reported in at least 8 (9%) patients treated with ULTOMIRIS and in 4 (4%) patients treated with placebo. Of these infections, one fatal case of COVID-19 pneumonia was identified in a patient treated with ULTOMIRIS and one case of infection led to discontinuation of ULTOMIRIS.
Adverse Reactions for NMOSD
Most common adverse reactions in adult patients with NMOSD (incidence 10%) were COVID-19, headache, back pain, arthralgia, and urinary tract infection. Serious adverse reactions were reported in 8 (13.8%) patients with NMOSD receiving ULTOMIRIS.
Adverse Reactions for IgAN
Most common adverse reaction in adult patients with IgAN (incidence 10%) was upper respiratory tract infection. Serious adverse reactions were reported in 11 (4.6%) patients with IgAN receiving ULTOMIRIS and in 22 (9.0%) patients receiving placebo.
DRUG INTERACTIONS
Plasma Exchange, Plasmapheresis, and Intravenous Immunoglobulins
Concomitant use of ULTOMIRIS with plasma exchange (PE), plasmapheresis (PP), or intravenous immunoglobulin (IVIg) treatment can reduce serum ravulizumab concentrations and requires a supplemental dose of ULTOMIRIS.
Neonatal Fc Receptor Blockers
Concomitant use of ULTOMIRIS with neonatal Fc receptor (FcRn) blockers (e.g., efgartigimod) may lower systemic exposures and reduce effectiveness of ULTOMIRIS. Closely monitor for reduced effectiveness of ULTOMIRIS.
USE IN SPECIFIC POPULATIONS
Pregnancy Exposure Registry
There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ULTOMIRIS during pregnancy. Healthcare providers and patients may call 1-833-793-0563 or go to www.UltomirisPregnancyStudy.com to enroll in or to obtain information about the registry.
To report SUSPECTED ADVERSE REACTIONS, contact Alexion Pharmaceuticals, Inc. at 1-844-259-6783 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see accompanying full Prescribing Information for ULTOMIRIS, including Boxed WARNING regarding serious and life-threatening or fatal meningococcal infections.
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Notes
Immunoglobulin A Nephropathy (IgAN)
Immunoglobulin A nephropathy (IgAN) is a rare, inflammatory disease of the kidneys that can lead to chronic kidney disease (CKD) and progress to end-stage kidney disease (ESKD). It begins when the body develops abnormal IgA proteins resulting in immune complexes that are deposited in the kidneys causing damage. The deposition of these complexes activates the complement system, leading to terminal complement-driven inflammation. This results in damage and loss of essential parts of the kidney, including cells in the glomeruli, the part of the kidneys that filters and cleans the blood. Over time, this damage impacts the ability of the kidneys to function properly, resulting in chronic kidney disease that can progress to end-stage kidney disease./4
The signs and symptoms of IgAN can include blood in the urine (hematuria), foamy urine (proteinuria), swelling in hands and feet (edema) and high blood pressure (hypertension)./11 Most people with IgAN do not experience symptoms in the early stages of the disease, and therefore, it often goes undetected until it has progressed. At diagnosis, irreversible kidney damage may have already occurred./12,13 Approximately half of people with IgAN who have elevated protein levels in urine or reduced kidney function are at high risk of progression to ESKD, or kidney failure, within 10 years of diagnosis.7-9
I CAN (ALXN1210-IgAN-320)
I CAN (ALXN1210-IgAN-320) is a global, Phase III, randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of ULTOMIRIS(R) in adults with immunoglobulin A nephropathy (IgAN) who are at risk of disease progression. Participants were on stable concomitant IgAN treatment(s) consistent with standard of care for at least three months prior to screening.2
Participants were randomized 1:1 to receive either ULTOMIRIS or placebo, administered intravenously for a total of 106 weeks. Patients in the treatment arm received a loading dose of ULTOMIRIS on Day 1, followed by regular weight-based maintenance dosing of ULTOMIRIS beginning on Day 15 and then every eight weeks through the 106-week blinded treatment period. Patients who completed the randomized control period had the option to enter an open-label access period.2
The primary endpoints are change from baseline in proteinuria based on 24-hour urine protein creatinine ratio (UPCR) at week 34 and change from baseline in estimated glomerular filtration rate (eGFR) at week 106, assessed at the interim analysis and final analysis, respectively. Key secondary endpoints for the final analysis include reduction in 24-hour UPCR 50% from baseline at week 34, change from baseline in proteinuria based on 24-hour UPCR at week 10, time to sustained 30% eGFR decline up to week 106 and time to first occurrence of composite kidney event up to week 106. The trial was designed to enroll approximately 510 participants from 28 countries across North America, South America, Europe, Asia and Australia.2
ULTOMIRIS(R) (ravulizumab-cwvz)
ULTOMIRIS(R) (ravulizumab-cwvz), the longest-acting C5 complement inhibitor, provides immediate, complete and sustained complement inhibition. The medication works by inhibiting the C5 protein in the terminal complement cascade, a part of the body's immune system. When activated in an uncontrolled manner, the complement cascade over-responds, leading the body to attack its own healthy cells. Following a loading dose, ULTOMIRIS is administered intravenously every eight weeks in adults, or every four or eight weeks in pediatric patients (based on body weight).
ULTOMIRIS is approved in the US, EU, Japan, China and other countries for the treatment of certain adults with paroxysmal nocturnal hemoglobinuria (PNH) and is also approved for certain children with PNH in the US, EU, China and other countries.
ULTOMIRIS is also approved in the US, EU, Japan and other countries for the treatment of certain adults and children with atypical hemolytic uremic syndrome (aHUS).
Additionally, ULTOMIRIS is approved in the US, EU, Japan, China and other countries for the treatment of certain adults with generalized myasthenia gravis (gMG).
Further, ULTOMIRIS is approved in the US, EU, Japan, China and other countries for the treatment of certain adults with neuromyelitis optica spectrum disorder (NMOSD).
ULTOMIRIS is approved in the US and other countries for adults with primary immunoglobulin A nephropathy (IgAN).
ULTOMIRIS is being assessed as a treatment for additional indications as part of a broad development program.
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Alexion
Alexion, AstraZeneca Rare Disease, is focused on serving patients and families affected by rare diseases and devastating conditions through the discovery, development and delivery of life-changing medicines. A pioneering leader in rare disease for more than three decades, Alexion was the first to translate the complex biology of the complement system into transformative medicines, and today it continues to build a diversified pipeline across disease areas with significant unmet need, using an array of innovative modalities. As part of AstraZeneca, Alexion is continually expanding its global geographic footprint to serve more rare disease patients around the world. It is headquartered in Boston, US.
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AstraZeneca
AstraZeneca (LSE/STO/NYSE: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines in Oncology, Rare Disease, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca's innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit astrazeneca-us.com and follow the Company on Social Media @AstraZeneca.
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References
1. ULTOMIRIS(R) (ravulizumab-cwvz) US prescribing information; October 2026.
2. ClinicalTrials.gov. A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Participants With Immunoglobulin A Nephropathy (IgAN). NCT Identifier: NCT06291376. Available here. Accessed October 2026.
3. Barratt J, et al. Ravulizumab in IgA nephropathy: a prespecified interim analysis of a randomized phase 3 trial (I CAN). Presented at European Renal Association (ERA) Congress; 2026 Jun 6; Glasgow, Scotland.
4. Cheung CK, et al. The pathogenesis of IgA nephropathy and implications for treatment. Nat Rev Nephrol. 2025;21(1):9-23. doi:10.1038/s41581-024-00885-3. Epub 2024 Sep 4.
5. AstraZeneca Data on File - Epidemiology estimates are composed of a triangulation of different data sources including Data Monitor, Decision Resources Group, Kantar Health, and internal input (updated as of July 2026). Available here. Accessed October 2026.
6. DeCongelio M, et al. The incidence and prevalence of immunoglobulin A nephropathy in the United States. Clin Nephrol. 2025;103(1):19-25.
7. Pitcher D, et al. Long-term outcomes in IgA nephropathy. Clin J Am Soc Nephrol. 2023;18:727-38.
8. Sim JJ, et al. CKD progression, kidney failure, and mortality among US patients with IgA nephropathy. Nephrology Dialysis Transplantation. 2025;40(11): 2104-2117.
9. Wong K, et al. Effects of rare kidney diseases on kidney failure: a longitudinal analysis of the UK National Registry of Rare Kidney Diseases (RaDaR) cohort. Lancet. 2024;403(10433):1279-1289.
10. Lafayette R, et al. Effects of Ravulizumab on Proteinuria and Hematuria in IgAN: A Prespecified Interim Analysis of the Phase 3 I CAN Trial. Presented at the American Society of Nephrology (ASN) Kidney Week Congress; 2026 Oct 23; Denver, CO. Abstract FR-OR107.
11. Rajasekaran A, et al. IgA Nephropathy: An Interesting Autoimmune Kidney Disease. Am J Med Sci. 2021; 361(2):176-194.
12. Kidney Disease: Improving Global Outcomes (KDIGO) IgAN and IgAV Work Group, et al. KDIGO 2025 Clinical Practice Guideline for the Management of Immunoglobulin A Nephropathy (IgAN) and Immunoglobulin A Vasculitis (IgAV). Kidney Int. 2025; 108(4S): S1-S71.
13. Stamellou E, et al. IgA nephropathy. Nat Rev Dis Primers. 2023;9(1):67. doi:10.1038/s41572-023-00476-9.
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Original text here: https://www.astrazeneca-us.com/content/az-us/media/press-releases/2026/ULTOMIRIS-ravulizumab-cwvz-received-accelerated-approval-in-the-US-as-first-and-only-C5-complement-inhibitor-to-reduce-proteinuria-in-adults-with-primary-immunoglobulin-A-nephropathy.html
[Category: BizPharmaceuticals]
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ULTOMIRIS(R) (ravulizumab-cwvz) received accelerated approval in the US as first and only C5 complement inhibitor to reduce proteinuria in adults with primary immunoglobulin A nephropathy
21 October 2026
Based on I CAN Phase III trial results from prespecified interim analysis in which ULTOMIRIS demonstrated 43.4% reduction in proteinuria vs placebo at 34 weeks
Late-breaking results from I CAN Phase III trial will be presented at American Society of Nephrology's Kidney Week 2026
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Alexion, ... Show Full Article WILMINGTON, Delaware, Oct. 22 -- AstraZeneca, a biopharmaceutical company, issued the following news release: * * * ULTOMIRIS(R) (ravulizumab-cwvz) received accelerated approval in the US as first and only C5 complement inhibitor to reduce proteinuria in adults with primary immunoglobulin A nephropathy 21 October 2026 Based on I CAN Phase III trial results from prespecified interim analysis in which ULTOMIRIS demonstrated 43.4% reduction in proteinuria vs placebo at 34 weeks Late-breaking results from I CAN Phase III trial will be presented at American Society of Nephrology's Kidney Week 2026 - Alexion,AstraZeneca Rare Disease's ULTOMIRIS(R) (ravulizumab-cwvz) has been approved in the US to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression.
This indication is approved under accelerated approval based on reduction of proteinuria. It has not been established whether ULTOMIRIS slows kidney function decline in patients with IgAN. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the ongoing I CAN Phase III trial evaluating ULTOMIRIS in adults with IgAN who are at risk of disease progression./1 The trial is ongoing and will assess the primary endpoint of change from baseline in estimated glomerular filtration rate (eGFR) at week 106, with data intended to support traditional FDA approval./2
The approval follows Priority Review by the US Food and Drug Administration (FDA) based on positive results from a prespecified interim analysis of the I CAN trial. Results showed ULTOMIRIS demonstrated a 43.4% reduction in proteinuria vs placebo at 34 weeks./3 ULTOMIRIS is administered intravenously every eight weeks in adults (based on body weight), following a loading dose./1
IgAN is a rare, inflammatory disease of the kidneys that can lead to chronic kidney disease and progress to end-stage kidney disease (ESKD). It begins when the body develops abnormal IgA proteins resulting in immune complexes that are deposited in the kidneys causing damage. The deposition of these complexes activates the complement system, leading to terminal complement-driven inflammation. This results in damage and loss of essential parts of the kidney, including cells in the glomeruli, the part of the kidneys that filters and cleans the blood./4 IgAN affects more than 200,000 people in the US./5,6 Approximately half of people with IgAN who have elevated protein levels in urine or reduced kidney function are at high risk of progression to ESKD, or kidney failure, within 10 years of diagnosis./7-9
Richard Lafayette, MD, Professor of Medicine (Nephrology) at the Stanford University Medical Center, Founder and Director of the Stanford Glomerular Disease Center and external scientific committee co-chair of the I CAN trial, said: "For many people living with IgAN, persistent proteinuria remains a significant challenge despite available treatments, signaling ongoing kidney injury and heightened risk of disease progression. With this approval of ULTOMIRIS, physicians now have a C5 inhibitor that delivers sustained terminal complement inhibition, targeting a central driver of kidney inflammation to meaningfully reduce proteinuria in patients living with this progressive disease."
Bonnie Schneider, Director & Co-Founder, IgA Nephropathy Foundation, said: "This approval reflects the importance of continued innovation to help improve outcomes for people living with IgAN. With its approved use across several other rare diseases and established safety profile, ULTOMIRIS provides a new treatment option in IgAN that gives patients - and their physicians - more choice as they navigate their care."
Marc Dunoyer, Chief Executive Officer, Alexion, said: "As the first and only C5 inhibitor approved for the reduction of proteinuria in adults with IgAN, ULTOMIRIS offers a new treatment option for people living with this serious disease. Many patients continue to face the risk of progression to kidney failure, underscoring the need for more targeted therapies that can slow the course of disease. This approval marks the fifth indication for ULTOMIRIS, building on Alexion's pioneering leadership across multiple complement-mediated rare diseases."
In the prespecified interim analysis from the I CAN Phase III trial, ULTOMIRIS demonstrated a 46.6% reduction in 24-hour urine protein creatinine ratio (UPCR) from baseline (95% confidence interval [CI]: 39.0%, 53.2%) at week 34, compared to 5.6% (95% CI: -4.9%, 15.0%) in patients receiving placebo, resulting in a placebo-adjusted treatment effect of 43.4% (95% CI: 33.5%, 51.8%; p<0.0001). The reduction in proteinuria was rapid, observed as early as week 10 with ULTOMIRIS (36.7% [95% CI: 30.2%, 42.6%]) and sustained through 34 weeks, compared to placebo (8.5% [95% CI: 0.5%, 15.8%]). These results were consistent across patient subgroups, reflecting diverse demographic and baseline clinical characteristics and disease severity.3
The safety profile observed in the trial was consistent with the known profile of ULTOMIRIS and was generally well tolerated, with no new safety concerns identified. Based on results from the prespecified interim analysis, the most common adverse events (AE) reported were upper respiratory tract infection (11.3%), nasopharyngitis (9.2%) and infusion-related reactions (8.4%) in those treated with ULTOMIRIS; and upper respiratory tract infection (10.2%), nasopharyngitis (9.0%) and hypertension (6.6%) in those receiving placebo./3
The interim results from the I CAN trial were presented at the 2026 European Renal Association (ERA) Congress, and late-breaking results will be presented at the American Society of Nephrology's Kidney Week on 23 October 2026./3,10
Regulatory submissions based on the interim results from the I CAN trial are also under review in Japan and additional countries.
INDICATIONS & IMPORTANT SAFETY INFORMATION for ULTOMIRIS(R) (ravulizumab-cwvz)
INDICATIONS
Paroxysmal Nocturnal Hemoglobinuria (PNH)
ULTOMIRIS is indicated for the treatment of adult and pediatric patients one month of age and older with paroxysmal nocturnal hemoglobinuria (PNH).
Atypical Hemolytic Uremic Syndrome (aHUS)
ULTOMIRIS is indicated for the treatment of adult and pediatric patients one month of age and older with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy (TMA).
Limitation of Use:
ULTOMIRIS is not indicated for the treatment of patients with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS).
Generalized Myasthenia Gravis (gMG)
ULTOMIRIS is indicated for the treatment of adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody-positive.
Neuromyelitis Optica Spectrum Disorder (NMOSD)
ULTOMIRIS is indicated for the treatment of adult patients with neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody positive.
Immunoglobulin A Nephropathy (IgAN)
ULTOMIRIS is indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression.
This indication is approved under accelerated approval based on reduction of proteinuria. It has not been established whether ULTOMIRIS slows kidney function decline in patients with IgAN. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory clinical trial.
IMPORTANT SAFETY INFORMATION
WARNING: SERIOUS MENINGOCOCCAL INFECTIONS
ULTOMIRIS, a complement inhibitor, increases the risk of serious infections caused by Neisseria meningitidis [see Warnings and Precautions (5.1)]. Life-threatening and fatal meningococcal infections have occurred in patients treated with complement inhibitors. These infections may become rapidly life-threatening or fatal if not recognized and treated early.
* Complete or update vaccination for meningococcal bacteria (for serogroups A, C, W, Y, and B) at least 2 weeks prior to the first dose of ULTOMIRIS, unless the risks of delaying ULTOMIRIS therapy outweigh the risk of developing a serious infection. Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for vaccinations against meningococcal bacteria in patients receiving a complement inhibitor. See Warnings and Precautions (5.1) for additional guidance on the management of the risk of serious infections caused by meningococcal bacteria.
* Patients receiving ULTOMIRIS are at increased risk for invasive disease caused by Neisseria meningitidis, even if they develop antibodies following vaccination. Monitor patients for early signs and symptoms of serious meningococcal infections and evaluate immediately if infection is suspected.
Because of the risk of serious meningococcal infections, ULTOMIRIS is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called ULTOMIRIS and SOLIRIS REMS [see Warnings and Precautions (5.2)].
CONTRAINDICATIONS
* Initiation in patients with unresolved serious Neisseria meningitidis infection.
WARNINGS AND PRECAUTIONS
Serious Meningococcal Infections
ULTOMIRIS, a complement inhibitor, increases a patient's susceptibility to serious, life-threatening, or fatal infections caused by meningococcal bacteria (septicemia and/or meningitis) in any serogroup, including non-groupable strains. Life-threatening and fatal meningococcal infections have occurred in both vaccinated and unvaccinated patients treated with complement inhibitors.
Revaccinate patients in accordance with ACIP recommendations considering the duration of ULTOMIRIS therapy. Note that ACIP recommends an administration schedule in patients receiving complement inhibitors that differs from the administration schedule in the vaccine prescribing information. If urgent ULTOMIRIS therapy is indicated in a patient who is not up to date with meningococcal vaccines according to ACIP recommendations, provide antibacterial drug prophylaxis and administer meningococcal vaccines as soon as possible. Various durations and regimens of antibacterial drug prophylaxis have been considered, but the optimal durations and drug regimens for prophylaxis and their efficacy have not been studied in unvaccinated or vaccinated patients receiving complement inhibitors, including ULTOMIRIS. The benefits and risks of treatment with ULTOMIRIS, as well as those associated with antibacterial drug prophylaxis in unvaccinated or vaccinated patients, must be considered against the known risks for serious infections caused by Neisseria meningitidis.
Vaccination does not eliminate the risk of serious meningococcal infections, despite development of antibodies following vaccination.
Closely monitor patients for early signs and symptoms of meningococcal infection and evaluate patients immediately if infection is suspected. Inform patients of these signs and symptoms and instruct patients to seek immediate medical care if they occur. Promptly treat known infections. Meningococcal infection may become rapidly life-threatening or fatal if not recognized and treated early. Consider interruption of ULTOMIRIS in patients who are undergoing treatment for serious meningococcal infection depending on the risks of interrupting treatment in the disease being treated.
ULTOMIRIS and SOLIRIS REMS
Due to the risk of serious meningococcal infections, ULTOMIRIS is available only through a restricted program called ULTOMIRIS and SOLIRIS REMS.
Prescribers must enroll in the REMS, counsel patients about the risk of serious meningococcal infection, provide patients with the REMS educational materials, assess patient vaccination status for meningococcal vaccines (against serogroups A, C, W, Y, and B) and vaccinate if needed according to current ACIP recommendations two weeks prior to the first dose of ULTOMIRIS. Antibacterial drug prophylaxis must be prescribed if treatment must be started urgently, and the patient is not up to date with both meningococcal vaccines according to current ACIP recommendations at least two weeks prior to the first dose of ULTOMIRIS. Patients must receive counseling about the need to receive meningococcal vaccines and to take antibiotics as directed, signs and symptoms of meningococcal infection, and be instructed to carry the Patient Safety Card at all times during and for 8 months following ULTOMIRIS treatment.
Further information is available at www.UltSolREMS.com or 1-888-765-4747.
Other Infections
Serious infections with Neisseria species (other than Neisseria meningitidis), including disseminated gonococcal infections, have been reported.
ULTOMIRIS blocks terminal complement activation; therefore, patients may have increased susceptibility to infections, especially with encapsulated bacteria, such as infections caused by Neisseria meningitidis but also Streptococcus pneumoniae, Haemophilus influenzae, and to a lesser extent, Neisseria gonorrhoeae. Children treated with ULTOMIRIS may be at increased risk of developing serious infections due to Streptococcus pneumoniae and Haemophilus influenzae type b (Hib). Administer vaccinations for the prevention of Streptococcus pneumoniae and Haemophilus influenzae type b (Hib) infections according to ACIP recommendations. Patients receiving ULTOMIRIS are at increased risk for infections due to these organisms, even if they develop antibodies following vaccination.
Monitoring Disease Manifestations after ULTOMIRIS Discontinuation
Treatment Discontinuation for PNH
After discontinuing treatment with ULTOMIRIS, closely monitor for signs and symptoms of hemolysis, identified by elevated LDH along with sudden decrease in PNH clone size or hemoglobin, or re-appearance of symptoms such as fatigue, hemoglobinuria, abdominal pain, shortness of breath (dyspnea), major adverse vascular event (including thrombosis), dysphagia, or erectile dysfunction. Monitor any patient who discontinues ULTOMIRIS for at least 16 weeks to detect hemolysis and other reactions. If signs and symptoms of hemolysis occur after discontinuation, including elevated LDH, consider restarting treatment with ULTOMIRIS.
Treatment Discontinuation for aHUS
ULTOMIRIS treatment of aHUS should be a minimum duration of 6 months. Due to heterogeneous nature of aHUS events and patient-specific risk factors, treatment duration beyond the initial 6 months should be individualized. There are no specific data on ULTOMIRIS discontinuation. After discontinuing treatment with ULTOMIRIS, patients should be monitored for clinical symptoms and laboratory signs of TMA complications for at least 12 months. TMA complications post-discontinuation can be identified if any of the following is observed: Clinical symptoms of TMA include changes in mental status, seizures, angina, dyspnea, thrombosis or increasing blood pressure. In addition, at least two of the following laboratory signs observed concurrently and results should be confirmed by a second measurement 28 days apart with no interruption: a decrease in platelet count of 25% or more as compared to either baseline or to peak platelet count during ULTOMIRIS treatment; an increase in serum creatinine of 25% or more as compared to baseline or to nadir during ULTOMIRIS treatment; or, an increase in serum LDH of 25% or more as compared to baseline or to nadir during ULTOMIRIS treatment. If TMA complications occur after discontinuation, consider reinitiation of ULTOMIRIS treatment or appropriate organ-specific supportive measures.
Thromboembolic Event Management
The effect of withdrawal of anticoagulant therapy during treatment with ULTOMIRIS has not been established. Treatment should not alter anticoagulant management.
Infusion-Related Reactions
Administration of ULTOMIRIS may result in systemic infusion-related reactions, including anaphylaxis and hypersensitivity reactions. In clinical trials, infusion-related reactions occurred in approximately 1 to 8% of patients, including lower back pain, abdominal pain, muscle spasms, drop or elevation in blood pressure, rigors, limb discomfort, drug hypersensitivity (allergic reaction), and dysgeusia (bad taste). These reactions did not require discontinuation of ULTOMIRIS. If signs of cardiovascular instability or respiratory compromise occur, interrupt ULTOMIRIS and institute appropriate supportive measures.
ADVERSE REACTIONS
Adverse Reactions for PNH
Adverse reactions reported in 10% or more of patients with PNH were upper respiratory tract infection and headache. Serious adverse reactions were reported in 15 (6.8%) patients receiving ULTOMIRIS. The serious adverse reactions in patients treated with ULTOMIRIS included hyperthermia and pyrexia. No serious adverse reaction was reported in more than 1 patient treated with ULTOMIRIS. One fatal case of sepsis was identified in a patient treated with ULTOMIRIS. In clinical studies, clinically relevant adverse reactions in 1% of adult patients include infusion-related reactions.
Adverse reactions reported in 10% of pediatric patients treated with ULTOMIRIS who were treatment-naive vs eculizumab-experienced were anemia (20% vs 25%), abdominal pain (0% vs 38%), constipation (0% vs 25%), pyrexia (20% vs 13%), upper respiratory tract infection (20% vs 75%), pain in extremity (0% vs 25%), and headache (20% vs 25%).
Adverse Reactions for aHUS
Most common adverse reactions in patients with aHUS (incidence 20%) were upper respiratory tract infection, diarrhea, nausea, vomiting, headache, hypertension and pyrexia. Serious adverse reactions were reported in 42 (57%) patients with aHUS receiving ULTOMIRIS. The most frequent serious adverse reactions reported in more than 2 patients (2.7%) treated with ULTOMIRIS were hypertension, pneumonia and abdominal pain.
Adverse reactions reported in 20% of pediatric patients treated with ULTOMIRIS were diarrhea, constipation, vomiting, pyrexia, upper respiratory tract infection, decreased vitamin D, headache, cough, rash, and hypertension.
Adverse Reactions for gMG
Most common adverse reactions in adult patients with gMG (incidence 10%) were diarrhea and upper respiratory tract infection. Serious adverse reactions were reported in 20 (23%) of patients treated with ULTOMIRIS and in 14 (16%) patients receiving placebo. The most frequent serious adverse reactions were infections reported in at least 8 (9%) patients treated with ULTOMIRIS and in 4 (4%) patients treated with placebo. Of these infections, one fatal case of COVID-19 pneumonia was identified in a patient treated with ULTOMIRIS and one case of infection led to discontinuation of ULTOMIRIS.
Adverse Reactions for NMOSD
Most common adverse reactions in adult patients with NMOSD (incidence 10%) were COVID-19, headache, back pain, arthralgia, and urinary tract infection. Serious adverse reactions were reported in 8 (13.8%) patients with NMOSD receiving ULTOMIRIS.
Adverse Reactions for IgAN
Most common adverse reaction in adult patients with IgAN (incidence 10%) was upper respiratory tract infection. Serious adverse reactions were reported in 11 (4.6%) patients with IgAN receiving ULTOMIRIS and in 22 (9.0%) patients receiving placebo.
DRUG INTERACTIONS
Plasma Exchange, Plasmapheresis, and Intravenous Immunoglobulins
Concomitant use of ULTOMIRIS with plasma exchange (PE), plasmapheresis (PP), or intravenous immunoglobulin (IVIg) treatment can reduce serum ravulizumab concentrations and requires a supplemental dose of ULTOMIRIS.
Neonatal Fc Receptor Blockers
Concomitant use of ULTOMIRIS with neonatal Fc receptor (FcRn) blockers (e.g., efgartigimod) may lower systemic exposures and reduce effectiveness of ULTOMIRIS. Closely monitor for reduced effectiveness of ULTOMIRIS.
USE IN SPECIFIC POPULATIONS
Pregnancy Exposure Registry
There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ULTOMIRIS during pregnancy. Healthcare providers and patients may call 1-833-793-0563 or go to www.UltomirisPregnancyStudy.com to enroll in or to obtain information about the registry.
To report SUSPECTED ADVERSE REACTIONS, contact Alexion Pharmaceuticals, Inc. at 1-844-259-6783 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see accompanying full Prescribing Information for ULTOMIRIS, including Boxed WARNING regarding serious and life-threatening or fatal meningococcal infections.
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Notes
Immunoglobulin A Nephropathy (IgAN)
Immunoglobulin A nephropathy (IgAN) is a rare, inflammatory disease of the kidneys that can lead to chronic kidney disease (CKD) and progress to end-stage kidney disease (ESKD). It begins when the body develops abnormal IgA proteins resulting in immune complexes that are deposited in the kidneys causing damage. The deposition of these complexes activates the complement system, leading to terminal complement-driven inflammation. This results in damage and loss of essential parts of the kidney, including cells in the glomeruli, the part of the kidneys that filters and cleans the blood. Over time, this damage impacts the ability of the kidneys to function properly, resulting in chronic kidney disease that can progress to end-stage kidney disease./4
The signs and symptoms of IgAN can include blood in the urine (hematuria), foamy urine (proteinuria), swelling in hands and feet (edema) and high blood pressure (hypertension)./11 Most people with IgAN do not experience symptoms in the early stages of the disease, and therefore, it often goes undetected until it has progressed. At diagnosis, irreversible kidney damage may have already occurred./12,13 Approximately half of people with IgAN who have elevated protein levels in urine or reduced kidney function are at high risk of progression to ESKD, or kidney failure, within 10 years of diagnosis.7-9
I CAN (ALXN1210-IgAN-320)
I CAN (ALXN1210-IgAN-320) is a global, Phase III, randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of ULTOMIRIS(R) in adults with immunoglobulin A nephropathy (IgAN) who are at risk of disease progression. Participants were on stable concomitant IgAN treatment(s) consistent with standard of care for at least three months prior to screening.2
Participants were randomized 1:1 to receive either ULTOMIRIS or placebo, administered intravenously for a total of 106 weeks. Patients in the treatment arm received a loading dose of ULTOMIRIS on Day 1, followed by regular weight-based maintenance dosing of ULTOMIRIS beginning on Day 15 and then every eight weeks through the 106-week blinded treatment period. Patients who completed the randomized control period had the option to enter an open-label access period.2
The primary endpoints are change from baseline in proteinuria based on 24-hour urine protein creatinine ratio (UPCR) at week 34 and change from baseline in estimated glomerular filtration rate (eGFR) at week 106, assessed at the interim analysis and final analysis, respectively. Key secondary endpoints for the final analysis include reduction in 24-hour UPCR 50% from baseline at week 34, change from baseline in proteinuria based on 24-hour UPCR at week 10, time to sustained 30% eGFR decline up to week 106 and time to first occurrence of composite kidney event up to week 106. The trial was designed to enroll approximately 510 participants from 28 countries across North America, South America, Europe, Asia and Australia.2
ULTOMIRIS(R) (ravulizumab-cwvz)
ULTOMIRIS(R) (ravulizumab-cwvz), the longest-acting C5 complement inhibitor, provides immediate, complete and sustained complement inhibition. The medication works by inhibiting the C5 protein in the terminal complement cascade, a part of the body's immune system. When activated in an uncontrolled manner, the complement cascade over-responds, leading the body to attack its own healthy cells. Following a loading dose, ULTOMIRIS is administered intravenously every eight weeks in adults, or every four or eight weeks in pediatric patients (based on body weight).
ULTOMIRIS is approved in the US, EU, Japan, China and other countries for the treatment of certain adults with paroxysmal nocturnal hemoglobinuria (PNH) and is also approved for certain children with PNH in the US, EU, China and other countries.
ULTOMIRIS is also approved in the US, EU, Japan and other countries for the treatment of certain adults and children with atypical hemolytic uremic syndrome (aHUS).
Additionally, ULTOMIRIS is approved in the US, EU, Japan, China and other countries for the treatment of certain adults with generalized myasthenia gravis (gMG).
Further, ULTOMIRIS is approved in the US, EU, Japan, China and other countries for the treatment of certain adults with neuromyelitis optica spectrum disorder (NMOSD).
ULTOMIRIS is approved in the US and other countries for adults with primary immunoglobulin A nephropathy (IgAN).
ULTOMIRIS is being assessed as a treatment for additional indications as part of a broad development program.
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Alexion
Alexion, AstraZeneca Rare Disease, is focused on serving patients and families affected by rare diseases and devastating conditions through the discovery, development and delivery of life-changing medicines. A pioneering leader in rare disease for more than three decades, Alexion was the first to translate the complex biology of the complement system into transformative medicines, and today it continues to build a diversified pipeline across disease areas with significant unmet need, using an array of innovative modalities. As part of AstraZeneca, Alexion is continually expanding its global geographic footprint to serve more rare disease patients around the world. It is headquartered in Boston, US.
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AstraZeneca
AstraZeneca (LSE/STO/NYSE: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines in Oncology, Rare Disease, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca's innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit astrazeneca-us.com and follow the Company on Social Media @AstraZeneca.
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References
1. ULTOMIRIS(R) (ravulizumab-cwvz) US prescribing information; October 2026.
2. ClinicalTrials.gov. A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Participants With Immunoglobulin A Nephropathy (IgAN). NCT Identifier: NCT06291376. Available here. Accessed October 2026.
3. Barratt J, et al. Ravulizumab in IgA nephropathy: a prespecified interim analysis of a randomized phase 3 trial (I CAN). Presented at European Renal Association (ERA) Congress; 2026 Jun 6; Glasgow, Scotland.
4. Cheung CK, et al. The pathogenesis of IgA nephropathy and implications for treatment. Nat Rev Nephrol. 2025;21(1):9-23. doi:10.1038/s41581-024-00885-3. Epub 2024 Sep 4.
5. AstraZeneca Data on File - Epidemiology estimates are composed of a triangulation of different data sources including Data Monitor, Decision Resources Group, Kantar Health, and internal input (updated as of July 2026). Available here. Accessed October 2026.
6. DeCongelio M, et al. The incidence and prevalence of immunoglobulin A nephropathy in the United States. Clin Nephrol. 2025;103(1):19-25.
7. Pitcher D, et al. Long-term outcomes in IgA nephropathy. Clin J Am Soc Nephrol. 2023;18:727-38.
8. Sim JJ, et al. CKD progression, kidney failure, and mortality among US patients with IgA nephropathy. Nephrology Dialysis Transplantation. 2025;40(11): 2104-2117.
9. Wong K, et al. Effects of rare kidney diseases on kidney failure: a longitudinal analysis of the UK National Registry of Rare Kidney Diseases (RaDaR) cohort. Lancet. 2024;403(10433):1279-1289.
10. Lafayette R, et al. Effects of Ravulizumab on Proteinuria and Hematuria in IgAN: A Prespecified Interim Analysis of the Phase 3 I CAN Trial. Presented at the American Society of Nephrology (ASN) Kidney Week Congress; 2026 Oct 23; Denver, CO. Abstract FR-OR107.
11. Rajasekaran A, et al. IgA Nephropathy: An Interesting Autoimmune Kidney Disease. Am J Med Sci. 2021; 361(2):176-194.
12. Kidney Disease: Improving Global Outcomes (KDIGO) IgAN and IgAV Work Group, et al. KDIGO 2025 Clinical Practice Guideline for the Management of Immunoglobulin A Nephropathy (IgAN) and Immunoglobulin A Vasculitis (IgAV). Kidney Int. 2025; 108(4S): S1-S71.
13. Stamellou E, et al. IgA nephropathy. Nat Rev Dis Primers. 2023;9(1):67. doi:10.1038/s41572-023-00476-9.
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Original text here: https://www.astrazeneca-us.com/content/az-us/media/press-releases/2026/ULTOMIRIS-ravulizumab-cwvz-received-accelerated-approval-in-the-US-as-first-and-only-C5-complement-inhibitor-to-reduce-proteinuria-in-adults-with-primary-immunoglobulin-A-nephropathy.html
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