CAPR INVESTOR DEADLINE: Capricor Therapeutics, Inc. Investors with Substantial Losses Have Opportunity to Lead Shareholder Class Action Lawsuit Before September 28, 2026 Deadline

The U.S. Food and Drug Administration (FDA) has extended the review period for Capricor Therapeutics, Inc.'s Biologics License Application (BLA), extending the decision date for its cell therapy, deramiocel, from August 22, 2026, to November 22, 2026. This extension follows a turbulent July 2026 Advisory Committee meeting and the submission of additional data, including 24-month open-label extension data from the Phase 3 HOPE-3 study, and a request to focus the indication on upper limb function. The lawsuit alleges that Capricor and its executives made misleading statements regarding clinical trial data and changes to the statistical analysis plan (SAP) without FDA agreement. The company announced positive topline results from the HOPE-3 study on December 3, 2025, leading to a significant stock price increase and a subsequent stock offering. However, on July 27, 2026, the FDA released briefing documents revealing that Capricor had made unagreed-upon post-hoc modifications to its SAP, and that the study did not meet its pre-specified efficacy endpoints. This disclosure caused Capricor's stock to drop approximately 64% in a single day, and an Advisory Committee subsequently voted against the drug's efficacy.