Capricor jumps as FDA agrees to review fresh Duchenne drug data
BUZZ-Capricor jumps as FDA agrees to review fresh Duchenne drug data Updates
** Shares of drug developer Capricor Therapeutics CAPR.O rise 67.7% to $7.06
** Stock on track for its biggest one-day pct gain in over 8 months, if gains hold
** Shares were trading about 139% above their 52-week low of $2.96 hit on July 30
** 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
** "Apparent regulatory pivot supports the upside case" for approval, say Oppenheimer analysts
** More than 42 million shares traded, about 8.2 times the stock's 30-day average volume
** Despite Friday's rally, Capricor shares remained about 64% below their level before last month's regulatory setback
** As of last close, stock down 85.4% YTD
(Reporting by Kamal Choudhury in Bengaluru)