Capricor Therapeutics' stock surged 71% to $7.19 on Friday, Aug. 14, 2026, after the company announced plans to amend its FDA approval application for its Duchenne muscular dystrophy (DMD) cell therapy, deramiocel, following a negative FDA advisory committee vote on efficacy. The FDA advisory committee voted 9–3 against recommending approval of deramiocel for DMD cardiomyopathy, citing concerns about the analysis of trial endpoints and the trial population's baseline heart function. Capricor plans to submit an amendment focused on the primary endpoint of upper limb function from the Phase 3 HOPE‑3 trial, including 24‑month data from the open‑label extension and additional analyses, which the FDA has indicated it is willing to review. The FDA’s action date for the existing application remains Aug. 22, 2026; after the amendment is submitted, the PDUFA date is expected to be extended by about three months, consistent with treatment of the resubmission as a major amendment. ...
- Get link
- X
- Other Apps