That’s a huge fall, Capricor Therapeutics stock Falls 26% Following FDA Briefing

Capricor Therapeutics (NASDAQ:CAPR) shares fell 40% Monday after the FDA posted briefing documents ahead of the company’s July 29 advisory committee meeting.

The Cellular, Tissue, and Gene Therapies Advisory Committee will meet to discuss the company’s resubmitted Biologics License Application for deramiocel, proposed for treatment of cardiomyopathy in male patients with Duchenne muscular dystrophy (DMD). The committee will consider whether results from the pivotal HOPE-3 study provide substantial evidence of effectiveness for the proposed indication.

The FDA briefing documents outlined the regulatory standards for approval, noting that substantial evidence of effectiveness generally requires at least two adequate and well-controlled clinical investigations, each convincing on its own.

Deramiocel is an investigational allogeneic cellular product derived from cadaver donor hearts. The original BLA submission was based on results from the phase 2 HOPE-2 study and its open-label extension, which showed no evidence of effectiveness on skeletal or cardiac function based on left ventricular ejection fraction and other cardiac parameters. The original application