Thursday - December 11, 2025
FDA Issues Warning Letter to Ponya Therapeutics
December 10, 2025
WASHINGTON, Dec. 10 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to Lux Therapeutics LLC dba Ponya Therapeutics LLC from the Office of Compliance and Biologics Quality:

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Recipient: Mekonnen Abebe, Owner and Chief Executive Officer, Lux Therapeutics LLC dba Ponya Therapeutics LLC, 13 Corporate Blvd NE, Brookhaven, GA 30329, United States, MAbebe@ponyadx.com

Issuing Office: Office of . . .

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