Shares of Capricor Therapeutics Inc (NASDAQ: CAPR) jumped 15.7% on Tuesday after Oppenheimer upgraded the biotech stock to Outperform from Perform, citing regulatory progress for its experimental treatment deramiocel in Duchenne muscular dystrophy.
Analyst Leland Gershall set a price target of $54, reflecting confidence in the drug’s approval prospects following a recent update from the U.S. Food and Drug Administration. The FDA accepted additional material submitted since last month’s advisory committee meeting as a major amendment, establishing a new Prescription Drug User Fee Act (PDUFA) action date of November 22.
The regulator also indicated it may consider an indication for Duchenne muscular dystrophy based on upper limb function, aligning with the primary endpoint of Capricor’s Phase 3 HOPE-3 study. Gershall noted in a research note that the FDA’s signal suggests efficacy appears "less ambiguous" for this indication compared with cardiomyopathy.
Capricor’s CEO Linda Marbán has stated the company plans to release data from the 24-month open-label extension of the HOPE-3 study ahead of the PDUFA date, alongside other submissions to the FDA. The analyst added that the stock should "trend gradually higher" as investor sentiment reassesses deramiocel’s approval prospects.
The upgrade follows regulatory developments that have heightened expectations for deramiocel, a cell-based therapy under review for the rare genetic disorder.
