Capricor more than doubles as FDA agrees to review fresh Duchenne drug data
BUZZ-Capricor more than doubles as FDA agrees to review fresh Duchenne drug data ** Shares of drug developer Capricor Therapeutics CAPR.O rise 116.9% to $9.13 premarket
** Co, late on Thursday, said the U.S. FDA agreed to review new data on its Duchenne muscular dystrophy therapy, deramiocel
** The company plans to submit additional trial data showing benefits in upper limb muscle function
** "The FDA has indicated it is willing to review this amendment and, upon receipt, to extend the PDUFA action date accordingly," CEO Linda Marban said
** The agency's decision was expected by August 22
** Cantor analyst Kristen Kluska called the FDA's willingness to review the new muscle data a "very unexpected, potentially positive surprise", adding that it reduces regulatory risks
** The U.S. Department of Health and Human Services, which oversees the FDA, did not immediately respond to a Reuters request for comment
** As of last close, stock down 85.4% YTD
(Reporting by Kamal Choudhury in Bengaluru)