CAPR Downgraded to Perform by Oppenheimer
Oppenheimer downgrades CAPR due to dim outlook on deramiocel
CAPR Oppenheimer downgraded Capricor Therapeutics to Perform from Outperform.
The firm comes away from the July 29 Food and Drug Administration advisory committee meeting with a dim outlook on deramiocel's upcoming regulatory action.
The unfavorable vote "on the single question" of cardiomyopathy efficacy was accompanied by lukewarm sentiment around upper limb functional benefit.
While Oppenheimer believes another Complete Response Letter is likely, there may remain some potential for a conditional approval with confirmatory study requirement, presuming the agency can be flexible as the current review is for Duchenne muscular dystrophy heart disease only.