Capricor hits 2-yr low after FDA panel votes against Duchenne therapy

Capricor shares plunged roughly 83%, from Friday's close of $19.70 to Thursday's $3.27, since the FDA released briefing documents on Monday.

More than 14.3 million shares traded, about 4.5 times the stock's 30-day average volume.

The FDA is expected to decide on the therapy by Aug. 22, though it is not bound by the panel's recommendation.

Including the session's move, the stock is down 88.7% year to date.

The U.S. FDA's panel of independent advisers voted 9-3 against Capricor's cell therapy, deramiocel, citing a lack of convincing evidence of benefit in Duchenne-related heart disease.

FDA staff raised concerns that Capricor changed key statistical analyses after the study was completed.

Cantor Fitzgerald analysts said the FDA's tone was "extremely negative" and sees an "unlikely path forward" for deramiocel.

Shares of drug developer Capricor Therapeutics CAPR.O fell 50% to $3.27.

Shares hit a more than two-year low and are down about 92% from their 52-week high of $40.37 reached in Dec. 2025.