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

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

Updates

** Shares of drug developer Capricor Therapeutics CAPR.O fall 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

** 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' says the FDA's tone was "extremely negative" and sees an "unlikely path forward" for deramiocel

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

** More than 14.3 mln shares traded, about 4.5 times the stock's 30-day avg volume

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

Including session's move, stock down 88.7% YTD


(Reporting by Kamal Choudhury in Bengaluru)

((Kamal.Choudhury@thomsonreuters.com;))

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