Oppenheimer sees potential accelerated approval ahead of Capricor DMD update

Oppenheimer notes that on Tuesday, Capricor Therapeutics will provide a regulatory update on deramiocel for Duchenne muscular dystrophy following recent pre-BLA meeting and related FDA interactions. Recall that on last month’s quarterly update call, Capricor intimated that it may be able to register deramiocel for sale in the U.S. through the accelerated approval pathway, the firm says. Oppenheimer believes it is likely that tomorrow’s update will support this potential, and regards last week’s expansion of the Nippon Shinyaku partnership as a favorable signal. The firm also thinks that deramiocel’s cardioprotective benefits may factor into the drug’s labeled indication given benefit shown here. Oppenheimer further believes such would put Capricor in strong position for pricing/reimbursement prospects given the lack of medicines approved for DMD-associated cardiomyopathy. The firm reiterates an Outperform rating on the shares.