FDA Panel Votes 9-3 Against Capricor's Duchenne Therapy, Shares Crash 60%
CAPR is trading near its 52-week low of $4.3 (33% below the low) on elevated volume (8.1× avg).
Summary
An FDA advisory committee voted 9-3 against deramiocel's effectiveness data for Duchenne muscular dystrophy-related heart disease, sending shares down nearly 60% in premarket trading. The panel cited unconvincing cardiac-benefit evidence, missing data, and uncertainty over whether the heart-function measure reflected meaningful patient benefit. This follows FDA staff concerns raised on Monday and a prior Complete Response Letter last year. With the PDUFA date on August 22, the negative vote makes approval unlikely, and analysts expect another rejection. The company's lead asset is now at high risk, and the ongoing lawsuit against its distributor adds further uncertainty.
At the time of this announcement, CAPR was trading at $2.88 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $380.5M. The 52-week trading range was $4.30 to $40.37. This news item was assessed with negative market sentiment and an importance score of 10 out of 10. Source: Reuters.