Hagens Berman Alerts Capricor Therapeutics, Inc. (NASDAQ: CAPR) Investors to FDA Review Extension for Deramiocel Amid Ongoing Securities Class Action and September 28 Lead Plaintiff Deadline

Hagens Berman Sobol Shapiro LLP notifies investors in Capricor Therapeutics, Inc. (NASDAQ: CAPR) of the upcoming September 28, 2026 lead plaintiff deadline in the ongoing securities class action. The U.S. Food and Drug Administration (FDA) has extended the review period for Capricor's Biologics License Application (BLA) for its cell therapy, deramiocel, for Duchenne muscular dystrophy (DMD). The decision date has been moved from August 22, 2026, to November 22, 2026. The lawsuit alleges that Capricor and its executives made materially false and misleading statements regarding clinical trial data and regulatory pathway for Deramiocel. Specifically, defendants allegedly failed to disclose that they adopted changes to the pre-specified statistical analysis plan (SAP) without FDA agreement prior to resubmitting its BLA. On December 3, 2025, Capricor announced positive topline results from its pivotal Phase 3 HOPE-3 Study, leading to a 370% stock surge. However, on July 27, 2026, the FDA revealed briefing documents indicating that Capricor made unagreed-upon post-hoc modifications to its SAP, and that the HOPE-3 study did not meet its pre-specified primary and secondary efficacy endpoints. Capricor shares crashed approximately 64% on July 27, 2026, and an Advisory Committee subsequently voted against the drug's efficacy.