San Francisco – September 10, 2026 -- Investors in Capricor Therapeutics, Inc. (NASDAQ: CAPR) have until September 28, 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 November 22, 2026
On August 24, 2026, Capricor disclosed that the FDA extended the PDUFA target action date for its lead cell therapy deramiocel from August 22, 2026, to November 22, 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.
Lawsuit alleges undisclosed changes to trial statistics
The class action, covering purchasers of Capricor securities between December 17, 2025, and July 26, 2026, alleges that Capricor and its executives made materially misleading statements about deramiocel's regulatory pathway. The complaint claims defendants failed to disclose that pre-specified statistical analysis plan changes were adopted without FDA agreement before the BLA resubmission.
Topline results drove a 370% stock surge and a $150 million offering
On December 3, 2025, Capricor announced what it called positive topline results from the pivotal Phase 3 HOPE-3 study, with its CEO citing statistically significant improvements in skeletal and cardiac function. Shares surged 370% that day, closing up $23.60. The next day, Capricor priced a public offering of roughly 6 million shares at $25 per share.
FDA briefing documents triggered a 64% single-day collapse
On July 27, 2026, the FDA released briefing documents ahead of an Advisory Committee meeting stating that HOPE-3 "did not meet its pre-specified primary and secondary efficacy endpoints,