Capricor Therapeutics (NASDAQ:CAPR) faces a three-month extension to the FDA review timeline for Deramiocel after the agency moved the PDUFA target action date for the Duchenne muscular dystrophy cell therapy from August 22 to November 22, 2026. The extension follows Capricor’s submission of a major amendment containing 24-month open-label extension data from the Phase 3 HOPE-3 study and additional analyses supporting a refined proposed indication focused on upper limb function.

– New PDUFA target action date of November 22, 2026 follows submission of additional Phase 3 HOPE-3 data and analyses supporting a refined proposed indication – SAN DIEGO, Aug. 24, 2026 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment of rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) target action

/PRNewswire/ -- Robbins LLP informs investors that a securities class action has been filed on behalf of all persons and entities that purchased or otherwise...

New York, New York and New Orleans, Louisiana--(Newsfile Corp. - August 24, 2026) - Kahn Swick & Foti, LLC ("KSF")...