Capricor tanks after FDA panel votes against Duchenne therapy
BUZZ-Capricor tanks after FDA panel votes against Duchenne therapy ** Shares of drug developer Capricor Therapeutics CAPR.O fall 55% to $2.93 premarket
** 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' says 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 last close, stock was down 77.2% YTD
(Reporting by Kamal Choudhury in Bengaluru)