Capricor plummets after FDA flags concerns over its Duchenne therapy
CAPR•FDA had previously declined approval
The FDA last year declined to approve the muscle disorder drug, citing a lack of efficacy data.
Capricor cites late-stage trial results
Capricor said in December that in a late-stage trial deramiocel significantly slowed the decline in muscle and heart function in patients compared with placebo.
Disease background and stock performance
Duchenne muscular dystrophy is a genetic disease that weakens muscles and affects the heart.
Up to the last close, the stock had fallen 31.7% year to date.
Shares fall after FDA staff raise effectiveness concerns
Shares of drug developer Capricor Therapeutics, CAPR.O, fell 69.2% to $6.06 in premarket trading after U.S. FDA staff reviewers raised concerns about whether the company's cell therapy, deramiocel, has sufficient evidence of effectiveness for treating cardiomyopathy in Duchenne muscular dystrophy.
