Capricor Plunges 55% After FDA Panel Rejects Duchenne Therapy Efficacy
Updated
Updated · moomoo.com · Jul 30
Capricor Plunges 55% After FDA Panel Rejects Duchenne Therapy Efficacy
3 articles · Updated · moomoo.com · Jul 30
Summary
Capricor Therapeutics fell 55.74% in premarket trading after an FDA advisory committee voted against the efficacy of deramiocel for Duchenne cardiomyopathy.
Multiple analyst downgrades compounded the selloff, reflecting fresh doubts that the therapy can win regulatory clearance.
A 9-3 panel vote on Wednesday found Capricor's clinical data did not provide substantial evidence of efficacy for deramiocel.
The FDA is expected to make its final decision by Aug. 22; while not bound by advisory panels, it usually follows their recommendations.