B.Riley initiates Capricor Therapeutics stock with buy rating

Investing.com - B.Riley initiated coverage on Capricor Therapeutics (NASDAQ:CAPR) with a buy rating and a $21.00 price target on Thursday. According to InvestingPro data, analysts maintain a strong buy consensus with price targets ranging from $22 to $77, suggesting significant upside potential from the current $10.05 trading price.

The research firm cited the potential of Capricor’s Deramiocel to become the first therapy for Duchenne Muscular Dystrophy-cardiomyopathy, which addresses the leading cause of mortality in DMD patients.

B.Riley highlighted Phase II data showing clinically meaningful preservation of cardiac function through four years, including left ventricular ejection fraction improvements of 1.9% and 1.2% at 24 and 36 months, respectively.

The firm suggested investors may have overestimated regulatory risks related to FDA disruption, noting that the agency appears to be adopting a more flexible, rare disease-focused approach that could benefit Deramiocel as the only safe and potentially disease-modifying option ahead of its August PDUFA date.

B.Riley projects that post-approval, Deramiocel could operate in a favorable commercial environment with a 100-200 patient base representing $25 million to $50 million in top-line revenue within one quarter of launch.

In other recent news, Capricor Therapeutics announced that the FDA will not require an Advisory Committee meeting for its Duchenne muscular dystrophy (DMD) therapy candidate, Deramiocel. The company’s Biologics License Application for Deramiocel is under Priority Review, with an action date set for August 31, 2025. Recent data from a four-year study showed that Deramiocel preserved cardiac function in DMD patients, suggesting potential long-term benefits. Despite these developments, Oppenheimer lowered its price target for Capricor, citing concerns about the FDA review process and the removal of key FDA reviewers. The investment firm remains cautious about Deramiocel’s approval in the current review cycle. Meanwhile, H.C. Wainwright maintained a Buy rating on Capricor, advising investors not to overreact to recent FDA personnel changes. The firm views Deramiocel as having a strong clinical profile, with the upcoming FDA decision seen as a buying opportunity. The unexpected administrative leave of key FDA officials has raised concerns about regulatory stability, but analysts suggest only minor impacts on trial designs in the near term.

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