Capricor rises after US FDA extends review of muscle disorder therapy
CAPR•FDA extends review of deramiocel by three months
Shares of Capricor Therapeutics (CAPR.O) rose 8.8% to $8.85 after the company said the U.S. Food and Drug Administration has extended the review of its experimental cell therapy for Duchenne muscular dystrophy by three months to November 22.
The extension will allow more time to review new clinical trial data submitted by the company for the drug deramiocel.
Company submitted additional trial data and analyses
Deramiocel aims to treat Duchenne, a rare and progressive genetic disease that causes muscle wasting and mostly affects boys.
Capricor said it submitted an amendment to the application that includes 24-month open-label extension data from its late-stage study and additional analyses supporting a narrower proposed indication focused on preserving upper limb function in patients with Duchenne muscular dystrophy.
In July, an FDA advisory panel voted nine-to-three against the effectiveness data of the drug.
Including session's moves, the stock is down 73% year-to-date.
