US FDA declines to approve Capricor’s muscle disorder therapy

(Reuters) -Capricor Therapeutics said on Friday the U.S. Food and Drug Administration has declined to approve its cell therapy deramiocel for a heart condition associated with Duchenne muscular dystrophy.

The FDA said it needed more data to prove the therapy is effective.

Shares of the San Diego-based company fell 33% premarket.

Cardiomyopathy, a condition that affects heart muscles, is the leading cause of death in patients with DMD, a genetic disorder characterized by progressive muscle degeneration and weakness.

(Reporting by Christy Santhosh in Bengaluru; Editing by Sahal Muhammed)