Capricor Therapeutics slide on report FDA regulator ousted over co's cell therapy

Shares of drug developer Capricor Therapeutics CAPR.O fall as much as 40.7% to $7.08, its second largest daily fall in the last 5 years; last down 30%

STAT News reports that FDA's chief regulator of cell and gene therapies, Nicole Verdun, was ousted over disagreements on the review of a cell therapy for Duchenne muscular dystrophy developed by Capricor

Co is seeking approval for its therapy, deramiocel, as a treatment for patients diagnosed with DMD cardiomyopathy — a heart muscle complication that can develop in individuals with the genetic condition that causes progressive muscle weakness

Verdun had scheduled an advisory committee meeting to review the therapy, "but Vinay Prasad, director of the FDA’s Center for Biologics Evaluation and Research, was skeptical of the treatment and decided unilaterally to cancel the meeting," STAT reports, citing a person familiar with the matter

FDA is set to make its decision for the therapy by August 31

The company did not immediately respond to a Reuters request for comment

Including session moves stock down 45.1% YTD