Capricor Therapeutics Inc. (NASDAQ: CAPR) shares surged 29% on Monday after the U.S. Food and Drug Administration extended the review period for its investigational cell therapy Deramiocel, pushing the Prescription Drug User Fee Act (PDUFA) target action date from August 22 to November 22, 2026.
The extension follows Capricor’s submission of additional Phase 3 HOPE-3 trial data and analyses to support a refined proposed indication for Deramiocel, an allogeneic cell therapy targeting Duchenne muscular dystrophy (DMD). The FDA’s Center for Biologics Evaluation and Research accepted the submission and classified it as a major amendment, citing the significant unmet medical need in DMD.
The amendment incorporates 24-month open-label extension data from the pivotal Phase 3 HOPE-3 study, alongside additional robustness analyses. Capricor requested the FDA review these data to support a refined indication focused on upper limb function, which served as the primary endpoint of the HOPE-3 trial. The company stated that the study met this endpoint by demonstrating a statistically significant benefit in upper limb function, positioning HOPE-3 as one of the most extensive clinical datasets evaluating this measure in DMD patients.
The FDA’s extension resulted from ongoing discussions with Capricor following a July 2026 Advisory Committee meeting. While the delay postpones the potential regulatory decision, the company’s shares reacted positively to the news, reflecting investor optimism regarding the therapy’s prospects in a high-need indication.
