Capricor Therapeutics investors face a September 28, 2026, deadline to ask a court to appoint them as lead plaintiff in an ongoing securities class action concerning alleged misstatements about Deramiocel, a cell therapy for Duchenne muscular dystrophy. Rosen Law Firm issued a new investor notice, following notices from Hagens Berman Sobol Shapiro LLP and Pomerantz LLP. The FDA extended the Prescription Drug User Fee Act target action date for Capricor’s Biologics License Application from August 22 to November 22, 2026, after classifying a submission containing 24-month open-label extension data from the Phase 3 HOPE-3 study and a proposed narrower indication focused on upper limb function as a major amendment. The litigation alleges that Capricor and certain executives failed to disclose changes to the trial’s pre-specified statistical analysis plan without FDA agreement before resubmitting the application. Capricor shares rose 370% after positive HOPE-3 topline results were reported on December 3, 2025, then fell 64% to $7 on July 27, 2026, after FDA briefing documents said the study had not met its pre-specified primary and secondary efficacy endpoints. An advisory committee later voted 9-3 against the drug’s efficacy, and shares fell another 36% to $4.19 on July 30. No class has been certified, and investors do not need to seek lead-plaintiff status to participate in any potential recovery.