Capricor jumps as FDA agrees to review fresh Duchenne drug data
CAPR•FDA agrees to review new Duchenne data
Shares of drug developer Capricor Therapeutics
CAPR.O rose 67.7% to $7.06, putting the stock on track for its biggest one-day percentage gain in over eight months if gains hold.
The shares were trading about 139% above their 52-week low of $2.96 hit on July 30.
The company said late on Thursday that the U.S. FDA agreed to review new data on its Duchenne muscular dystrophy therapy, deramiocel. Capricor 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, Oppenheimer analysts said.
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 the last close, the stock was down 85.4% year to date.
