Shares of drug developer Capricor Therapeutics (CAPR.O) fell 55% to $2.93 in premarket trading.
The U.S. FDA's panel of independent advisers voted 9-3 against Capricor's cell therapy, deramiocel, saying the company failed to provide convincing evidence that the therapy benefits Duchenne-related heart disease.
FDA staff raised concerns that Capricor changed key statistical analyses after the study was completed, potentially affecting the results.
Cantor Fitzgerald analysts said the FDA's tone was "extremely negative during the entire conversation" and sees an "unlikely path forward" for deramiocel.
Several panel members described the heart-function data as "fragile" due to missing data and uncertainty around the clinical benefit shown.
The FDA is expected to decide on the therapy by Aug. 22, though it is not bound by the panel's recommendation.
As of the last close, the stock was down 77.2% year to date.
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