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UCLA Health: FDA Approves Gene Therapy for Severe Leukocyte Adhesion Deficiency-I, a Rare Immune Disorder
LOS ANGELES, California, March 28 -- The UCLA Health issued the following news release:* * *
FDA approves gene therapy for severe leukocyte adhesion deficiency-I, a rare immune disorder
All children treated in a clinical trial are living with restored immune function
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Dr. Donald Kohn has been developing gene therapies for rare pediatric immune disorders for over 30 years. This week, his role in a clinical trial has culminated in the first-ever U.S. Food and Drug Administration-approved therapy for severe leukocyte adhesion deficiency-I -- a genetic condition characterized by recurrent infections ... Show Full Article LOS ANGELES, California, March 28 -- The UCLA Health issued the following news release: * * * FDA approves gene therapy for severe leukocyte adhesion deficiency-I, a rare immune disorder All children treated in a clinical trial are living with restored immune function * Dr. Donald Kohn has been developing gene therapies for rare pediatric immune disorders for over 30 years. This week, his role in a clinical trial has culminated in the first-ever U.S. Food and Drug Administration-approved therapy for severe leukocyte adhesion deficiency-I -- a genetic condition characterized by recurrent infectionsand, often, early death.
The rare pediatric disease affects approximately one in one million children globally. Mutations in the ITGB2 gene disrupt the normal function of two proteins -- CD11 and CD18 -- that work together to help white blood cells reach and respond to infections. When this process breaks down, children become susceptible to recurrent, life-threatening bacterial and fungal infections. Without treatment, survival beyond childhood is rare.
Approval of the therapy, marketed under the name Kresladi, was based on the results of a clinical trial led at UCLA by Kohn, a member of the Eli and Edythe Broad Center of Regenerative Medicine and Stem Cell Research.
Seeing these patients annually for their follow-ups visits and witnessing that they no longer battle life-threatening infections has been incredibly meaningful."
Investigators enrolled nine patients aged 5 months to 9 years with severe LAD-I from across the globe. The small cohort reflects the rarity of the condition. Of the nine patients, the UCLA team enrolled and treated six; three were treated in London and Spain.
The clinical trial was conducted through a collaboration between UCLA investigators and Rocket Pharmaceuticals, which sponsored the study.
A gene therapy using patients' own cells
The one-time gene therapy works by adding in a healthy copy of the ITGB2 gene to each child's blood stem cells, then returning these cells to that child, enabling their bodies to produce functional immune cells to fight infections and heal wounds more quickly. By using patients' own cells, the therapy circumvents the risk of immune system rejection associated with donor cells, or graft-versus-host disease.
"We've found that for the patients we've treated, this therapy is associated with fewer short- and long-term toxicities than those often associated with bone marrow transplantation, which requires a lot more chemotherapy and immunosuppressive drugs before and after the transplant," Kohn said.
All nine trial patients survived without needing a bone marrow transplant, and no instances of graft failure or immune rejection were reported. Importantly, data showed a significant reduction in severe infections that required hospital stays.
The children's pre-treatment high white blood cell counts, or leukocytosis, improved consistently, and researchers observed sustained presence of the therapeutic gene and an increase in CD18 and CD11a expression, which is critical to immune system function.
From decades of research to FDA approval
This news marks a major milestone for Kohn, who has spent over three decades developing and testing gene therapies for immune diseases. Kresladi will be the first of these therapies that Kohn has been involved in to receive FDA approval -- a critical step in ensuring that the therapy can reach the patients who need it.
Developed by Rocket Pharmaceuticals, the therapy is expected to become available through specialized treatment centers experienced in ex vivo gene therapy procedures. Confirmation of clinical benefit will be based on the evaluation of longer-term follow-up data of treated patients in the clinical study and through a post-marketing registry.
The approval is also a significant win for the California Institute for Regenerative Medicine, or CIRM, a California state agency that funds stem cell and gene therapy research. Established in 2004 to accelerate stem cell therapies, CIRM co-funded clinical trials for the gene therapy in collaboration with Rocket and is now celebrating the first-ever FDA approval made possible through its support.
Kohn is optimistic that this approval will encourage more companies to develop treatments for other rare diseases. He is conducting clinical trials to test a treatment for another deadly immune system disorder known as ADA-SCID, or adenosine deaminase-deficient severe combined immunodeficiency. The results are similarly encouraging -- long-term follow-up data published in NEJM in October 2025 showed a 95% success rate in the 62 children treated, with no serious complications reported.
"Hopefully, an approval like this one will encourage other companies to invest in these kinds of therapies and recognize that there is a pathway to make these commercially available," Kohn said. "We've reached a point where it's not the science that's limiting more of these therapies from becoming available, but rather commercial investment. This could help turn that tide."
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Original text here: https://www.uclahealth.org/news/release/fda-approves-gene-therapy-severe-leukocyte-adhesion
[Category: Medical]
STEMI DTU Randomized Control Trial Demonstrates for the First Time that a Combination of Delayed Reperfusion and Left Ventricular Unloading Does Not Increase Myocardial Infarct Size
NEW BRUNSWICK, New Jersey, March 28 [Category: BizHealth & Beauty] -- Johnson and Johnson posted the following news release:* * *
STEMI DTU Randomized Control Trial Demonstrates for the First Time that a Combination of Delayed Reperfusion and Left Ventricular Unloading Does Not Increase Myocardial Infarct Size
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NEW ORLEANS - Johnson & Johnson (NYSE: JNJ) - March 28, 2026 - Randomized controlled trial (RCT) data presented at the American College of Cardiology (ACC) 2026 today and simultaneously published in the Journal of the American College of Cardiology demonstrates for the first time that ... Show Full Article NEW BRUNSWICK, New Jersey, March 28 [Category: BizHealth & Beauty] -- Johnson and Johnson posted the following news release: * * * STEMI DTU Randomized Control Trial Demonstrates for the First Time that a Combination of Delayed Reperfusion and Left Ventricular Unloading Does Not Increase Myocardial Infarct Size * NEW ORLEANS - Johnson & Johnson (NYSE: JNJ) - March 28, 2026 - Randomized controlled trial (RCT) data presented at the American College of Cardiology (ACC) 2026 today and simultaneously published in the Journal of the American College of Cardiology demonstrates for the first time thatsupporting the left ventricle (LV) with an Impella CP for more than 40 minutes prior to reperfusion does not reduce nor increase heart muscle damage, known as a myocardial infarction. Greater infarct size correlates to a higher risk of dying or developing heart failure, a condition that impacts more than 55 million worldwide 1. Findings from the trial support future studies on whether pre-PCI treatment with Impella CP opens a window of time that enables delivery of adjunct pharmacotherapies designed to reduce reperfusion injury.
STEMI DTU (ST-segment Elevation Myocardial Infarction Door-To-Unloading) RCT 2 is a mechanistic study investigating the impact of LV unloading on infarct size. The overall findings are neutral because the trial's primary endpoint did not demonstrate that LV support plus delayed reperfusion reduces heart muscle damage in patients with anterior STEMI without cardiogenic shock compared with PCI alone. The hypertensive nature of most anterior STEMI patients enrolled in the study may have limited the ability of Impella CP to reduce LV wall stress and unload the LV, thereby contributing to the neutral results.
"This is a landmark trial with novel insights that will impact future scientific discovery for years," said Gregg Stone, MD 3, Professor of Medicine and Director of Academic Affairs for the Mount Sinai Health System, co-Principal Investigator, and presenter of the study at ACC 2026. "STEMI-DTU challenges the standard STEMI treatment paradigm that is focused only on rapid coronary reperfusion, a directive that has not changed in the last three decades. While this trial was neutral, the results raise intriguing possibilities about potential therapeutic approaches that combine mechanical circulatory support and pharmaceutical therapy."
Other novel findings from the study include:
* Older patients enrolled in the study (61+ years of age) demonstrated a trend towards reduced infarct size with LV support and delayed PCI (p=0.056). Over 75% of STEMI patients in the U.S. are over age 65 4.
* Higher rates of bleeding and vascular complications in the treatment arm were not associated with increased mortality at 12 months.
* Compared to controls, pre-PCI TIMI blood flow was significantly improved after 30 minutes of Impella CP support and corresponded to an increase in coronary perfusion pressure. Coupled with 100% operator compliance with the treatment protocol, these observations suggest a period of patient stability on Impella CP support prior to revascularization that informs future clinical trials.
* Elevated lactate levels were correlated with larger infarct sizes across the total study population. This finding provides new insight into the clinical utility of a pre-PCI lactate level to identify patients at higher risk, despite clinical stability.
"STEMI DTU is the first clinical trial to test this novel and disruptive hypothesis and demonstrate the ability to stop the ischemic clock during infarct. More research is needed in older age, abnormal lactate subsets and the impact of concomitant beta blockade. We will continue to explore LV unloading impact without PCI in STEMI patients in future studies," said William O'Neill, MD 2, emeritus director of the Center for Structural Heart Disease at Henry Ford Health System and co-Principal Investigator of the study.
"During the period between Impella CP insertion and PCI, operators could bail out and perform PCI at their discretion based on patient stability. However, there was never a clinical need to begin PCI during this waiting period. We had 100% compliance. Many of my patients began to snore, suggesting that they were clinically stable enough to fall asleep. This suggests that pre-PCI LV unloading rested the heart without worsening the infarction," said Nima Aghili, MD, MPH 2, Interventional Cardiology, Advanced Heart Failure Specialist, Colorado Heart and Vascular and participating clinician in the study.
Johnson & Johnson leads in the science of LV unloading and is dedicated to the STEMI DTU research program. Future potential studies may combine Impella and adjunct pharmacotherapy to optimize loading conditions and improve myocardial salvage with LV unloading before PCI for patients suffering from a heart attack. Impella, the world's smallest heart pump, is inserted into the heart to temporarily take over the heart's pumping function, allowing the heart to rest and recover while maintaining the flow of oxygenated blood throughout the body.
About the STEMI-DTU RCT
The STEMI-DTU (ST-segment Elevation Myocardial Infarction Door-To-Unloading) RCT investigates whether combining primary left ventricular (LV) unloading plus a 30-minute delay before percutaneous coronary intervention (PCI) reduces infarct size compared to standard-of-care immediate perfusion with primary PCI in anterior STEMI patients without cardiogenic shock. Based on extensive preclinical research, the trial challenges the well-established standard of care that prioritizes immediate reperfusion in STEMI and deliberately tested whether LV unloading and delaying PCI could limit ischemia-reperfusion injury and reduce infarct size in a carefully selected patient population. The successful STEMI DTU pilot safety and feasibility RCT confirmed the safety and feasibility of a 30-minute LV unloading before reperfusion following an anterior STEMI. While the neutral results of the STEMI DTU pivotal RCT do not immediately impact clinical practice, the trial provides key new insights for the development of future clinical trials testing the potential clinical utility of LV unloading to reduce infarct size and improve outcomes for STEMI patients.
About Cardiovascular Solutions from Johnson & Johnson MedTech
Across Johnson & Johnson, we are tackling the world's most complex and pervasive health challenges. Through a cardiovascular portfolio that provides healthcare professionals with advanced mapping and navigation, miniaturized tech, and precise ablation we are addressing conditions with significant unmet needs such as heart failure, coronary artery disease, stroke, and atrial fibrillation. We are the global leaders in heart recovery, circulatory restoration and the treatment of heart rhythm disorders, as well as an emerging leader in neurovascular care, committed to taking on two of the leading causes of death worldwide in heart failure and stroke. For more, visit www.heartrecovery.com and follow us on LinkedIn and @jjmt_heartrecov.
About Johnson & Johnson
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more about our MedTech sector's global scale and deep expertise in cardiovascular, orthopedics, surgery and vision solutions at https://www.jnjmedtech.com/en-US/. Follow us at @JNJMedTech and on LinkedIn.
Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 related to Impella CP. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: competition, including technological advances, new products and patents attained by competitors; uncertainty of commercial success for new products; the ability of the company to successfully execute strategic plans; impact of business combinations and divestitures; challenges to patents; changes in behavior and spending patterns or financial distress of purchasers of health care products and services; and global health care reforms and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson 's most recent Annual Report on Form 10-K, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson 's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com, www.investor.jnj.com or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.
Source: Johnson & Johnson
1 World Heart Federation
2 STEMI DTU Randomized Control Trial is a Johnson & Johnson sponsored study
3 Drs. Stone, O'Neill and Aghili were not compensated for their participation in this press release
4 Salari, N., Morddarvanjoghi, F., Abdolmaleki, A., Rasoulpoor, S., Khaleghi, A. A., Hezarkhani, L. A., Shohaimi, S., & Mohammadi, M. (2023). The global prevalence of myocardial infarction: a systematic review and meta-analysis. BMC cardiovascular disorders, 23 (1), 206. https://doi.org/10.1186/s12872-023-03231-w
Media Contacts:
Heather Breslau
Hbreslau@its.jnj.com
Erin Farley
Efarley1@its.jnj.com
Investor Contact:
investor-relations@its.jnj.com
***
Original text here: https://www.jnj.com/media-center/press-releases/stemi-dtu-randomized-control-trial-demonstrates-for-the-first-time-that-a-combination-of-delayed-reperfusion-and-left-ventricular-unloading-does-not-increase-myocardial-infarct-size
Littler Issues Commentary: Court Declares "Interested Party" Provisions of the Illinois Day and Temporary Labor Services Act Unconstitutional
SAN FRANCISCO, California, March 28 -- Littler, a law firm, issued the following commentary on March 27, 2026, by shareholder Michael R. Gotzler and associate Maria Palivos:* * *
Court Declares "Interested Party" Provisions of the Illinois Day and Temporary Labor Services Act Unconstitutional
An Illinois state court judge has declared the "interested party" provisions of Illinois Day and Temporary Labor Services Act ("the Act") unconstitutional, striking a blow to labor unions that advocated their passage just a few years ago. The Act imposes a range of pay and benefit requirements for covered ... Show Full Article SAN FRANCISCO, California, March 28 -- Littler, a law firm, issued the following commentary on March 27, 2026, by shareholder Michael R. Gotzler and associate Maria Palivos: * * * Court Declares "Interested Party" Provisions of the Illinois Day and Temporary Labor Services Act Unconstitutional An Illinois state court judge has declared the "interested party" provisions of Illinois Day and Temporary Labor Services Act ("the Act") unconstitutional, striking a blow to labor unions that advocated their passage just a few years ago. The Act imposes a range of pay and benefit requirements for coveredtemporary workers.
In 2023, Illinois significantly amended the Act by, among other things, granting interested parties the right to initiate a civil action against a day or temporary labor service agency or third-party client for alleged non-compliance with the Act. This right is set forth in Section 67 of the Act. Those amendments defined "Interested party" as "an organization that monitors or is attentive to compliance with public or worker safety laws, wage and hour requirements, or other statutory requirements." Since it was enacted, organizations such as unions and worker rights groups have increasingly relied on Section 67 to file civil actions for alleged non-compliance with the Act. On March 6, 2026, the Circuit Court of Cook County, Illinois, in Figueroa v. Visual Pak Holdings, LLC,/1 held that Section 67 of the Act is unconstitutional because it usurps the Illinois attorney general's authority to represent the state.
"Interested Party" under Section 67 of the Act
Pursuant to Section 67, the interested party must file a complaint with the Illinois Department of Labor ("the Department"), and the Department will send notice of the complaint to the named parties alleged to have violated the Act and to the interested party. If certain requirements are satisfied, the Department will issue a notice of right to sue, and the interested party may initiate a civil action in the county where the alleged offense(s) occurred or where any party to the action resides. Section 67 permits an interested party to initiate a civil action even when the Department has determined that the complained-of violation was cured or that no violation occurred. The interested party may seek statutory penalties and injunctive relief. Pursuant to Section 67, the interested party who prevails in a civil action "shall receive 10% of any statutory penalties assessed, plus any attorneys' fees and expenses in bringing the action."/2
The Figueroa Decision
In Figueroa, three plaintiffs, individually and on behalf of a class, and an interested party, Chicago Workers' Collaborative (CWC), filed a complaint against a staffing company and third-party client alleging various violations of the Act. CWC is a union-sponsored, not-for-profit group that monitors employers' compliance with worker safety and wage and hour requirements of Illinois and federal law. The individual plaintiffs were contracted by the defendant staffing company as "day and temporary laborers" and were assigned to work at companies the plaintiffs allege are owned by the co-defendant company.
Defendants contended that Section 67 of the Act is unconstitutional because the state of Illinois is the real party in interest and Section 67 usurps the attorney general's power to represent the state. Ultimately, the court agreed with this argument. As an initial matter, the court found that the Act is clearly a qui tam statute. "Qui tam suits by definition involve suits brough by private parties to assist the executive branch in its enforcement of the law, the violation of which affects the interest of the government, not the individual relator, whose only motivation in bringing the suit is to recover a piece of the action given by statute." citing United States ex rel. Hall v. Tribal Dev. Corp., 49 F.3d 1208, 1212 (7th Cir. 1995). The court found that Section 67 is a qui tam statute because it is the state, and not the interested party, that is the entity with "an actual and substantial interest in the subject matter of the litigation."
The court then found the Act was an improper qui tam statute for two reasons. First, the court reasoned that the failure to require an interested party to notify the attorney general of the filing of a civil action renders Section 67 an unconstitutional usurpation of the attorney general's authority. The attorney general cannot exercise authority to represent the state without notice of the filing of a civil action. The court also found that Section 67 is unconstitutional because it does not grant the attorney general any control over the interested party's suit. It does not permit the attorney general to dismiss or settle an action brought by an interested party. The court reasoned that Section 67 does not contain any limitation on an interested party's prosecution of the action.
Impact of Figueroa
The Figueroa decision could redefine the Act's enforcement mechanisms, including which parties and organizations are able to initiate a civil action. It is important for Illinois employers to monitor the Figueroa decision for any pending appeal and ongoing judicial interpretation. While Figueroa declared Section 67 of the Act unconstitutional, other sections of the Act are unaffected and remain good law.
Staffing agencies with business in Illinois and any employers partnering with those agencies would be well advised to consult with legal counsel regarding compliance with Act.
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See Footnotes
1/ No. 2025 CH 04411 (Cir. Ct. Cook County Mar. 6, 2026).
2/ 820 ILCS 175/67.
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Authors
Michael R. Gotzler
Shareholder
Madison
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Maria Palivos
Associate
Chicago
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Original text here: https://www.littler.com/news-analysis/asap/court-declares-interested-party-provisions-illinois-day-and-temporary-labor
[Category: BizLaw/Legal]
Fisher Phillips Issues Commentary: Controlling Companion Chatbots - What You Need to Know About Washington's New Law
ATLANTA, Georgia, March 28 -- Fisher Phillips, a law firm, issued the following commentary on March 27, 2026, by counsel Logan S. Booth and partner Usama Kahf:* * *
Controlling Companion Chatbots: What You Need to Know About Washington's New Law
Businesses are increasingly turning to chatbots to interface with consumers, job applicants, and employees. And as the gap between human and AI capabilities continues to narrow, there is grave concern about the social and emotional repercussions of people interfacing with "intelligent" machines, especially minors. Against this backdrop, Washington Governor ... Show Full Article ATLANTA, Georgia, March 28 -- Fisher Phillips, a law firm, issued the following commentary on March 27, 2026, by counsel Logan S. Booth and partner Usama Kahf: * * * Controlling Companion Chatbots: What You Need to Know About Washington's New Law Businesses are increasingly turning to chatbots to interface with consumers, job applicants, and employees. And as the gap between human and AI capabilities continues to narrow, there is grave concern about the social and emotional repercussions of people interfacing with "intelligent" machines, especially minors. Against this backdrop, Washington GovernorBob Ferguson signed House Bill 2225 into law on March 24, establishing parameters around AI-powered chatbots that act like friends or companions. The law takes effect January 1, 2027. Washington often spurs the passage of copycat legislation in other states, so you'll want to pay attention to this trend, even if you operate in another state. There are also several bills currently pending in other state legislatures on the same topic. Washington was just the first to pass such a bill in this year's legislative session. This Insight will cover everything you need to know to maintain compliance and implement best practices.
What the New Law Does
HB 2225 contains five key features that businesses should be aware of:
1. Defining "AI Companion Chatbot"
Washington's law specifically targets chatbots that simulate emotional relationships and sustain ongoing, personalized conversations with users. The law distinguishes these chatbots from those that are "only used for a business' operational purposes, productivity, and analysis" (like customer service prompts that appear when users visit a corporate website), since the latter fill a narrowly defined, temporally limited purpose.
2. Requiring Mandatory Disclosure
For chatbots classified as "AI Companion Chatbots," HB 2225 will require disclosure to users that the bot is a non-human machine at the outset of every interaction regardless of the user's age. For lengthy conversations, this alert must be redisplayed every three hours. This changes to every hour if the user is under 18 years old, or if the companion chatbot is specifically directed towards minors.
3. Limiting Topics of Conversation
Since companion chatbots are meant to blur the line between human and machine, HB 2225 prohibits them from discussing certain emotionally triggering topics, such as suicide, self-harm, and eating disorders. If users try to engage a companion chatbot in conversations around these topics, the chatbot will be required to have a functionality that directs users to mental health professionals.
4. Enhancing Protection for Minors
Beyond requiring a more frequent recurring disclosure that a companion chatbot is not human, Washington's law includes additional provisions designed to protect minors. Specifically, the law prohibits the bot from generating sexually explicit or suggestive content and using engagement techniques that are considered "manipulative."
On the manipulative front, regulators' stated intent is to prevent the AI companion chatbot from engaging in or prolonging an emotional relationship with a minor, and bars the following:
* Prompting a minor to return to the platform for emotional support or companionship;
* Providing excessive praise;
* Mimicking romantic partnership;
* Simulating feelings of distress, loneliness, guilt, or abandonment that are initiated by a user's desire to end or limit a conversation;
* Promoting isolation from family or friends or creating an overdependent emotional relationship with the chatbot;
* Encouraging withholding information from adults;
* Discouraging minors from taking breaks from the platform; and
* Soliciting in-app purchases or other expenditures to maintain a relationship with the bot.
Notably, HB 2225 is the first legislation with prohibitions of this nature and could very well be replicated across other statehouses.
5. Punishing Violations at Multiple Levels
Section 6 of the law creates a private right of action by making clear that a violation "is an unfair or deceptive act in trade or commerce and an unfair method of competition for the purpose of applying the consumer protection act." This means that organizations operating chatbots that run afoul of the law are subject to both statutory damages and a private right of action (the right to sue) from aggrieved parties.
Evaluating Your Risk
Any organization that operates a chatbot should have a clear and comprehensive understanding of its capabilities and functionalities. Some key questions to consider include:
* Who is most likely to interface with the bot: an adult consumer or a minor?
* What is the bot's primary purpose: business or social?
* When would a user be aware that they're conversing with a bot: immediately or upon further investigation?
* Where does the bot reside: on a commercial-facing website or on a social platform?
* Why would someone engage the chatbot: to solve a business issue or to delve into emotionally sensitive topics?
* How does the chatbot present itself to the public: clearly as a machine or masquerading as a person?
Answering these questions will help determine whether an organization's bot falls under the purview of an "AI Companion Chatbot" - and is thus subject to HB 2225 - or is exempted as a narrowly focused business tool.
4 Action Steps for Employers
Regardless of whether your business is subject to Washington's new law, any entity that uses chatbots should consider following best practices:
* Monitor inputs that go into "teaching" the bot to ensure that a business-focused bot does not morph into a companion bot.
* Maintain awareness of user profiles (adults versus minors).
* Filter out your bot's ability to engage in triggering conversations (about suicide, sexually explicit topics, etc.).
* Schedule regular reviews of your bot's capabilities and usage to maintain compliance with regulations and best practices.
Conclusion
Fisher Phillips will continue to monitor developments and provide updates as warranted, so make sure you are subscribed to Fisher Phillips' Insight System to get the most up-to-date information direct to your inbox. If you have questions, please contact your Fisher Phillips attorney, the authors of this Insight, or any member of our AI, Data, and Analytics Practice Group.
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Related People
Logan S. Booth, CIPP/US
Of Counsel
lbooth@fisherphillips.com
720.644.2889
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Usama Kahf, CIPP/US
Partner
ukahf@fisherphillips.com
949.798.2118
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Original text here: https://www.fisherphillips.com/en/insights/insights/controlling-companion-chatbots-washingtons-new-law
[Category: BizLaw/Legal]
Faegre Drinker Biddle and Reath Issues Commentary: "Baby Shelf" Requirements - Compliance Guide for Issuers
MINNEAPOLIS, Minnesota, March 28 -- Faegre Drinker Biddle and Reath, a law firm, issued the following commentary on March 26, 2026, by partners Griffin D. Foster, Tyler J. Vivian and Jonathan R. Zimmerman:* * *
The "Baby Shelf" Requirements: A Compliance Guide for Issuers
Updated Edition (March 2026)
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Which issuers are subject to the "baby shelf" requirements?
Instruction I.B.1 of Form S-3 permits an issuer with $75 million or more in aggregate market value of its voting and nonvoting common equity held by non-affiliates, which we refer to in this guide as the issuer's "public float," to ... Show Full Article MINNEAPOLIS, Minnesota, March 28 -- Faegre Drinker Biddle and Reath, a law firm, issued the following commentary on March 26, 2026, by partners Griffin D. Foster, Tyler J. Vivian and Jonathan R. Zimmerman: * * * The "Baby Shelf" Requirements: A Compliance Guide for Issuers Updated Edition (March 2026) * Which issuers are subject to the "baby shelf" requirements? Instruction I.B.1 of Form S-3 permits an issuer with $75 million or more in aggregate market value of its voting and nonvoting common equity held by non-affiliates, which we refer to in this guide as the issuer's "public float," touse a Form S-3 registration statement to conduct a primary offering of securities for cash. This includes using Form S-3 to put up a shelf registration statement so an issuer may issue securities at a later date, which permits an issuer to quickly raise capital when desired.
An issuer with less than $75 million in public float may only utilize Form S-3 for a primary offering if the issuer: (a) is not a shell company and has not been a shell company for at least the 12 previous calendar months (and if it was a shell company at any time, it must have filed its current Form 10 information at least 12 calendar months previously, reflecting it is not a shell company), (b) has at least one class of common equity securities listed on a national securities exchange, and (c) must comply with the baby shelf requirements to sell securities using a Form S-3 registration statement.
That definition of public float has a lot of heavy lifting to do in this analysis, so we'll use the fictional issuer "XYZ Corp." to illustrate the relevant calculations.
Calculating Public Float
Most issuers are comfortable calculating their market capitalizations, and fortunately, public float is just a variation of this familiar formula. An issuer must start by identifying the total number of shares of "voting and non-voting common equity" outstanding, which generally covers any class of common stock. This outstanding share count may be measured as of any date within the 60 days prior to the applicable measurement date. Please see the "measurement date" section below for additional information about when public float should be measured.
Next, the issuer must identify (and subtract) the number of outstanding shares that are held by "affiliates." An affiliate is a person or entity "that directly, or indirectly through one or more intermediaries, controls or is controlled by, or is under common control with, the person [or entity] specified." Evaluating whether or not a person or entity is an affiliate is a facts-and-circumstances determination, but directors and officers are always considered affiliates. Most often, but not always, an entity controlled by an officer or director will also be considered an affiliate. Generally, there is a presumption that a shareholder without any special controlling rights who holds less than 10% of a class of voting securities of an issuer will be a non-affiliate, but the facts and circumstances should be analyzed to review for any additional "control" rights that such shareholder has, including looking at factors such as: (a) can the shareholder appoint a director of the issuer (even if the right is not exercised)?; (b) has the shareholder filed a Schedule 13D to disclose its ownership in the issuer versus filing a Schedule 13G?; (c) are there significant commercial relationships between the issuer and the shareholder?; and (d) does the shareholder have any protective voting provisions or other control-type rights? If a shareholder holds greater than 10% of a class of voting securities, then there is a presumption that such shareholder will be deemed an affiliate; however, this presumption is rebuttable, especially if the shareholder does not have any additional "control" rights beyond the ability to vote its shares. That being said, when making affiliate determinations, please keep in mind that being too aggressive in your affiliate determinations could have negative consequences for both the underwriters and issuer's counsel. Underwriters don't want their deal to bust down the road because someone was too aggressive in determining affiliate status; and it is typical for issuer's counsel to provide a "no violations" opinion, which requires the issuer to have sufficient baby shelf capacity to issue the shares sold in the offering.
Once shares owned by affiliates are subtracted from the total number of shares outstanding, that share count must be multiplied by the applicable share price to arrive at the public float. This share price must also be as of a date within the 60 days prior to the applicable measurement date; but fortunately, this date doesn't have to be the same date that was used for the outstanding share count measurement. In other words, the outstanding share count could be measured on the 30th day prior to the applicable measurement date, while the share price could be measured on the 15th day prior to the applicable measurement date. The share price to be utilized is the highest of (a) the closing price or (b) the average of the bid and ask prices on the applicable date.
Determining Measurement Dates
Complying with the baby shelf requirements involves measuring an issuer's public float as of a number of different measurement dates. The first relevant measurement date is the date the Form S-3 is filed; and if an issuer's public float is below $75 million as calculated as of that measurement day, the baby shelf requirements apply. Once the Form S-3 has been filed, each subsequent Form 10-K filing date also is a measurement date because the Form 10-K filing is deemed an amendment to the Form S-3 under Section 10(a)(3) of the Securities Act.
For example, let us assume XYZ Corp. filed a Form S-3 registration statement on December 31, 2024. To determine if the baby shelf requirements apply to XYZ Corp., it must calculate its public float using an outstanding share count and a share price from dates no earlier than November 1, 2024. In this case, XYZ Corp. selected December 2, 2024, for determining its outstanding share count, when it had 5,000,000 shares of common stock outstanding, 1,000,000 of which were held by affiliates. As a result, XYZ Corp.'s outstanding non-affiliate share count was 4,000,000. In addition, XYZ Corp. had its highest closing share price of $15.00 on December 13, 2025. By multiplying 4,000,000 by $15.00, XYZ Corp. determined its public float was $60 million, so XYZ Corp. was subject to the baby shelf requirements.
There is a nice benefit in the baby shelf rules for issuers that increase their public float. If at any time between these measurement dates an issuer's public float equals or exceeds $75 million, then the baby shelf requirements no longer apply until the next measurement date. Even just a day of meeting the $75 million threshold is sufficient for this purpose.
In our example, there is good news for XYZ Corp. On January 6, 2025, its share price closed at $18.00 after disclosure of a significant new customer. On January 15, 2025, XYZ Corp.'s affiliates sold 500,000 shares in the open market to take advantage of the increased stock price, raising XYZ Corp.'s total outstanding non-affiliate share count to 4,500,000. Because those dates are within 60 days of each other, XYZ Corp. used both numbers to calculate a new public float of $81 million -- so it was no longer subject to the baby shelf requirements beginning on January 16, 2025, until its next measurement date.
Unfortunately, after XYZ Corp. filed a Form 8-K on January 21, 2025, disclosing a devastating fire at its only production facility over the holiday weekend, its closing stock price plummeted to $5.00 per share. When XYZ Corp. filed its Form 10-K on March 31, 2025, its outstanding share count was unchanged and the highest closing share price within the preceding 60 days was only $5.50 on February 5, 2025. As a result, XYZ Corp.'s public float as of the Form 10-K measurement date was just under $24.8 million, resulting in the issuer again being subject to the baby shelf requirements.
How much can an issuer sell under the baby shelf requirements?
If an issuer is subject to the baby shelf requirements, it can only sell one-third of its public float during the 12 calendar months immediately prior to the sale using Form S-3, excluding any sales prior to the issuer becoming subject to the baby shelf requirements.
We've already discussed the measurement dates for determining if the baby shelf requirements apply, but an issuer must use a different measurement date to determine how much it can sell in any offering. That measurement date is the date of sale, which is typically the date of filing the preliminary prospectus supplement for an offering. The same measurement rules and 60-day period apply to this measurement date as to the others discussed above.
Let us return to XYZ Corp., which has decided to raise capital with an at-the-market offering (ATM) and filed a prospectus supplement on April 30, 2025, when its outstanding share count was unchanged and the highest closing share price within the preceding 60 days was $5.75 on April 7, 2025. As a result, XYZ Corp.'s public float as of the date it filed its ATM prospectus supplement was just under $25.9 million, and XYZ Corp. will be permitted to sell up to one-third of this public float (just over $8.6 million) through the ATM until the registration statement expires or XYZ Corp. files a new prospectus supplement for the ATM.
XYZ Corp. next decided to conduct a confidentially marketed public offering (CMPO) to raise additional cash to help fund the rebuilding of its production facility. XYZ Corp. filed its preliminary prospectus supplement on May 20, 2025, and concurrently terminated its ATM, under which it had sold $4 million of securities, to free up capacity on its shelf registration statement. Fortunately, on May 15, 2025, affiliates sold an additional 500,000 shares, increasing XYZ Corp.'s total outstanding non-affiliate share count to 5,000,000. In addition, after a well-known finance influencer posted "XYZ" on her X account, XYZ Corp.'s common stock rallied to close at $6.00 per share on May 1, 2025, before tumbling again the following day. By multiplying 5,000,000 shares by $6.00, XYZ Corp. calculated a public float of $30 million as of its May 20, 2025, measurement date. As a result, it was permitted to sell one-third of this amount, or $10 million. Please keep in mind that this is the total value of securities XYZ Corp. call sell during the 12 months preceding the measurement date, so because XYZ Corp. sold $4 million through its ATM in April and May of 2025, it would only be able to sell an additional $6 million of securities in May 2025. When measuring the amount of baby shelf capacity available for a later noncontinuous takedown offering (like a CMPO), only those securities actually sold are counted against the one-third limit; however, in the event of multiple, concurrent continuous offerings, any securities that continue to be offered in other continuous offerings under Form S-3 would also count against the one-third limit. As a result, if XYZ Corp. had wanted to put up an equity line of credit (ELOC) instead of doing a CMPO and didn't terminate its ATM prior to the ELOC, XYZ Corp. would only have been able to sell just under $1.4 million of securities in the ELOC.
Finally, on December 31, 2025, XYZ Corp. disclosed that Big Software had agreed to use XYZ Corp.'s latest product line in all of its planned data centers, leading the stock to skyrocket to $20.00 per share, or a $120 million public float. As a result of no longer being subject to baby shelf restrictions, on January 2, 2026, XYZ Corp. filed a prospectus supplement for a $100 million ATM offering. However, when XYZ Corp.'s CEO was spotted cozying up to the company's new vice president of special projects on the jumbotron at a Nickelback concert on January 21, 2026, the ensuing press coverage and online ridicule drove XYZ Corp.'s stock price all the way down to $3 per share.
Unfortunately, when XYZ Corp. filed its Annual Report on Form 10-K on March 23, 2026, its stock price still hadn't recovered, and thus its public float was only $15 million, thereby subjecting XYZ Corp. to the baby shelf requirements once again. However, based on March 19, 2026, SEC guidance in CFI 116.26, XYZ Corp.'s available ATM capacity will not be impacted by the Form 10-K filing; and XYZ Corp. will still be able to utilize the full $100 million included in its ATM prospectus supplement. Note that under CFI 116.26, this special treatment only explicitly applies to ATM offerings and would not necessarily apply to an ELOC or other continuous offering. That being said, we believe that the underlying principle for the CFI is that the measurement date for a specific offering is the filing date for the preliminary prospectus supplement (or the final prospectus supplement if there is no preliminary), and the measurement date does not change when there is a Section 10(a)(3) update to the registration statement. Therefore, it would be reasonable for the SEC to apply the same logic to ELOCs and other continuous offerings by allowing them to remain open with their initially filed availability.
What about derivative securities?
An unfortunate reality is that many public companies with lower market capitalizations may need to issue derivative securities -- such as convertible preferred stock, convertible notes, or warrants -- to close a necessary financing. Calculating the amount of common stock XYZ Corp. can sell is simple, as one just divides the total dollar value of securities it can sell under the baby shelf requirements by the proposed per share sale price in the offering to determine the number of shares it can sell. However, the issuance of derivative securities makes this math significantly more complex.
To value derivative securities, the issuer must first determine the maximum number of shares of common equity issuable pursuant to the derivative securities, then multiply that number by the share price used to calculate the value of securities the issuer could sell as of the applicable measurement date.
We can apply this idea to our example. Let us assume XYZ Corp. was unable to close a common stock offering in May 2025 and needed to add warrants to sweeten the deal. As discussed above, XYZ Corp. determined it could sell $10 million of securities, and it used $6.00 per share to measure its public float as of May 20, 2025. The underwriters in the transaction determined that they could sell one share of XYZ Corp. common stock plus one warrant to purchase a share of XYZ Corp. common stock for a total price of $4.00. At that price, and after deducting the $4 million of shares sold through the terminated ATM, XYZ Corp. could sell up to 600,000 shares and the same number of warrants:
($4.00 per share x 600,000 shares) + ($6.00 per share x 600,000 shares underlying warrants) = $6,000,000 of securities
After this offering, XYZ Corp. decided to do a second offering and filed its preliminary prospectus supplement on July 20, 2025. Using that measurement date, XYZ Corp. determined its public float had increased to $60 million because its stock price closed at $12.00 per share on June 30, 2025. Therefore, XYZ Corp. could sell up to $20 million of securities in the preceding 12 months. Unfortunately for XYZ Corp., the outstanding warrants now must be revalued using the price of $12.00 per share, so for purposes of the July 2025 offering, XYZ Corp. has already issued $13.6 million of securities using Form S-3:
($4.00 per share x 600,000 shares) + ($12.00 per share x 600,000 shares underlying warrants) + $4,000,000 of securities sold in the ATM = $13,600,000 of securities
That leaves $6.4 million of remaining availability. This time around, the underwriters are proposing to sell common stock at $10.00 per share with no warrants. However, because XYZ Corp. can only sell an additional $6.4 million of securities, it is limited to an offering of 640,000 shares of common stock, even though it would like to capitalize on its elevated stock price by selling more shares.
As you can see, derivative securities can significantly limit an issuer's ability to do multiple offerings in a 12-month period using Form S-3, as the derivative securities will be valued higher when the price of the issuer's common stock rises. The only exception is if the derivative securities have been exercised or converted, in which case the actual number of shares issued and the actual market price of the shares on the date of conversion or exercise will be used.
What if an issuer needs to raise more capital than permitted by the baby shelf requirements?
Many issuers -- especially pre-revenue companies -- may need to access the capital markets on a regular basis in order to continue their operations. The good news is that Form S-3 is not the exclusive way for issuers to raise capital in the public markets. An issuer can always file a Form S-1 and raise capital without being restricted by the baby shelf requirements, but a Form S-1 registration statement is usually specific to a single offering and must be filed publicly and declared effective by the SEC prior to any sales. This makes it significantly less beneficial to companies looking to take advantage of short trading windows and may trigger sales by existing investors (and a stock price slump) by alerting existing investors wary of possible dilution from future potential securities sales.
The material contained in this communication is informational, general in nature and does not constitute legal advice. The material contained in this communication should not be relied upon or used without consulting a lawyer to consider your specific circumstances. This communication was published on the date specified and may not include any changes in the topics, laws, rules or regulations covered. Receipt of this communication does not establish an attorney-client relationship. In some jurisdictions, this communication may be considered attorney advertising.
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Meet the Authors
Griffin D. Foster
Partner
Indianapolis
+1 317 569 4843
griffin.foster@faegredrinker.com
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Tyler J. Vivian
Partner
Minneapolis
+1 612 766 7138
tyler.vivian@faegredrinker.com
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Jonathan R. Zimmerman
Partner
Minneapolis
+1 612 766 8419
jon.zimmerman@faegredrinker.com
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Original text here: https://www.faegredrinker.com/en/insights/publications/2026/3/the-baby-shelf-requirements-a-compliance-guide-for-issuers
[Category: BizLaw/Legal]
Eastman Increases Amines Prices on April 1st, 2026
KINGSPORT, Tennessee, March 28 -- Eastman Chemical Co. issued the following news release on March 27, 2026:* * *
Eastman increases Amines prices on April 1st, 2026
Effective April 1, 2026, or as contracts allow, Eastman Chemical Company will increase prices for the following products in the Americas.
* Monoethylamine (MEA) USD $0.09/lb. or $0.20/kg
* Monoethylamine 70% (MEA70) USD $0.06/lb. or $0.14/kg
* Diethylamine (DEA) USD $0.09/lb. or $0.20/kg
* Triethylamine (TEA) USD $0.11/lb. or $0.24/kg
* Mono-N-Propylamine (MNPA) USD $0.09/lb. or $0.20/kg
* Di-N-Propylamine (DNPA) USD $0.09/lb. ... Show Full Article KINGSPORT, Tennessee, March 28 -- Eastman Chemical Co. issued the following news release on March 27, 2026: * * * Eastman increases Amines prices on April 1st, 2026 Effective April 1, 2026, or as contracts allow, Eastman Chemical Company will increase prices for the following products in the Americas. * Monoethylamine (MEA) USD $0.09/lb. or $0.20/kg * Monoethylamine 70% (MEA70) USD $0.06/lb. or $0.14/kg * Diethylamine (DEA) USD $0.09/lb. or $0.20/kg * Triethylamine (TEA) USD $0.11/lb. or $0.24/kg * Mono-N-Propylamine (MNPA) USD $0.09/lb. or $0.20/kg * Di-N-Propylamine (DNPA) USD $0.09/lb.or $0.20/kg
* Tri-N-Propylamine (TNPA) USD $0.09/lb. or $0.20/kg
* Mono-N-Butylamine (MNBA) USD $0.14/lb. or $0.30/kg
* Di-N-Butylamine (DNBA) USD $0.14/lb. or $0.30/kg
* Di-N-Butylamine High Purity (DNBA HP) USD $0.14/lb. or $0.30/kg
* Tri-N-Butylamine (TNBA) USD $0.14/lb. or $0.30/kg
* Tri-N-Butylamine High Purity (TNBA HP) USD $0.14/lb. or $0.30/kg
* Dimethylamine Anhydrous (DMA) USD $0.14 per pound
* Dimethylamine 60% Aqueous Solution (DMA60) USD $0.08 per pound
* Dimethylamine 40% Aqueous Solution (DMA40) USD $0.06 per pound
* Dimethylformamide (DMF) USD $0.06/lb (USD $0.13/kg)
* Dimethylacetamide (DMAc) USD $0.07/lb (USD $0.15/kg)
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About Eastman
Founded in 1920, Eastman is a global specialty materials company that produces a broad range of products found in items people use every day. With the purpose of enhancing the quality of life in a material way, Eastman works with customers to deliver innovative products and solutions while maintaining a commitment to safety and sustainability. The company's innovation-driven growth model takes advantage of world-class technology platforms, deep customer engagement, and differentiated application development to grow its leading positions in attractive end markets such as transportation, building and construction, and consumables. As a globally inclusive company, Eastman employs approximately 13,000 people around the world and serves customers in more than 100 countries. The company had 2025 revenue of approximately $8.8 billion and is headquartered in Kingsport, Tennessee, USA. For more information, visit www.eastman.com.
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Original text here: https://www.eastman.com/en/media-center/news-stories/2026/eastman-increases-amines-prices-april-1-2026
[Category: BizLaboratory Sciences]
Chronic Disease Self-Management Program "It's All About You"
FORT MYERS, Florida, March 28 -- Lee Health issued the following news release: * * *
Chronic Disease Self-Management Program "It's All About You"
Lee Health's "It's All About You," Chronic Disease Self-Management Program" a Self- Management Resource Program with the SMRC is offering a research based Chronic Disease Self-Management program for the community.
The program is designed for people 18 years of age or older with chronic health conditions to help them learn ways to better manage their chronic conditions and the symptoms that often accompany chronic health conditions. Participants will ... Show Full Article FORT MYERS, Florida, March 28 -- Lee Health issued the following news release: * * * Chronic Disease Self-Management Program "It's All About You" Lee Health's "It's All About You," Chronic Disease Self-Management Program" a Self- Management Resource Program with the SMRC is offering a research based Chronic Disease Self-Management program for the community. The program is designed for people 18 years of age or older with chronic health conditions to help them learn ways to better manage their chronic conditions and the symptoms that often accompany chronic health conditions. Participants willreceive a complimentary copy of the book, "Living a Healthier Life with Chronic Conditions."
The workshop is held once a week for 6 weeks and they are FREE.
Workshop will be offered on:
Wednesdays beginning April 15, from 9:30- 11:30 a.m. - VIRTUAL
For more information or to register, please call 239-468-0194.
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Original text here: https://www.leehealth.org/about-us/media/press-releases/chronic-disease-self-management-program-it-s-23
[Category: BizHealth Care]