Capricor more than doubles 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 116.9% to $9.13 premarket after the company said late on Thursday that 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, the stock was down 85.4% year to date.
