Oppenheimer upgrades Capricor to Outperform with $54 target after FDA Deramiocel update

Capricor Therapeutics shares rose 15.7% after Oppenheimer upgraded the stock to Outperform from Perform with a $54 price target on constructive FDA feedback for deramiocel in Duchenne muscular dystrophy. Regulators accepted material submitted since last month’s advisory committee meeting as a major amendment, moved the PDUFA date to Nov. 22 from Aug. 22, and signaled they may consider an upper limb function-based indication aligned with the Phase 3 HOPE-3 primary endpoint, where efficacy appears less equivocal than for cardiomyopathy. CEO Linda Marbán said Capricor plans to disclose 24-month HOPE-3 open-label extension data ahead of the decision. The longer review follows a 9-3 advisory vote against effectiveness evidence and a securities lawsuit alleging HOPE-3 data-integrity issues, while partner Nippon Shinyaku assesses launch timing against about ¥11.4 billion ($71.6 million) of U.S. sales already in its fiscal 2027 forecast.

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Oppenheimer upgrades Capricor to Outperform with $54 target after FDA Deramiocel update - CoinPost Terminal