Capricor Investors Face Sept. 28 Deadline as FDA Delays Deramiocel Ruling
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San Francisco – September 11, 2026 -- Investors in Capricor Therapeutics, Inc. (NASDAQ: CAPR) have until September 11, 2026, to seek lead plaintiff status in a securities class action tied to the company's Duchenne muscular dystrophy therapy, deramiocel, as the FDA extends its review timeline.
FDA pushes deramiocel decision to September 11, 2026
On September 11, 2026, Capricor disclosed that the FDA extended the PDUFA target action date for its lead cell therapy deramiocel from September 11, 2026, to September 11, 2026. The agency classified the company's post-Advisory Committee submission as a major amendment, which included 24-month open-label extension data from the Phase 3 HOPE-3 study and a bid to narrow the therapy's indication to upper limb function.