H.C. Wainwright maintains Buy on Capricor stock with $77 target

On Wednesday, H.C. Wainwright reaffirmed its Buy rating on Capricor Therapeutics (NASDAQ:CAPR) shares, with a price target of $77.00. Currently trading at $13.70, the stock has shown remarkable momentum with a 176% return over the past year. According to InvestingPro data, analysts maintain a strong bullish consensus on the stock, with price targets ranging from $25 to $77. The firm’s endorsement follows the Food and Drug Administration’s (FDA) recent acceptance of Capricor’s Biologics License Application (BLA) for deramiocel, a treatment for Duchenne muscular dystrophy (DMD) cardiomyopathy, on March 4. The FDA also granted the therapy Priority Review status. With a market capitalization of $623 million and a strong liquidity position (current ratio of 4.19), InvestingPro analysis indicates the company is well-positioned to support its commercialization efforts.

DMD cardiomyopathy is currently without an approved treatment and is the leading cause of death among DMD patients. The BLA for deramiocel is supported by cardiac data from the Phase 2 HOPE-2 and HOPE-2 open-label extension trials. These trials indicate that deramiocel treatment can lead to improvements in cardiac function, a significant development given the lack of existing therapies.

The FDA has set a Prescription Drug User Fee Act (PDUFA) date of August 31 for a decision on deramiocel. While it remains unclear if an Advisory Committee (AdCom) meeting will be necessary for the application, Capricor is actively preparing for various outcomes. The company’s preparations include steps for potential approval and commercialization, such as enhancing pre-commercial activities, expanding manufacturing capabilities, and establishing partnerships crucial for deramiocel’s launch in the U.S. and international markets.

H.C. Wainwright’s analyst cited the therapy’s strong safety and efficacy records as reasons for maintaining a positive outlook on Capricor’s stock. The firm believes deramiocel could emerge as a first-in-class treatment option for DMD patients. While the stock exhibits high volatility with a beta of 4.11, InvestingPro subscribers can access 13 additional investment tips and comprehensive analysis through the Pro Research Report, helping investors make more informed decisions about this potential breakthrough biotech company.

In other recent news, Capricor Therapeutics has announced significant progress regarding its Biologics License Application (BLA) for deramiocel, a treatment for Duchenne muscular dystrophy (DMD) cardiomyopathy. The U.S. Food and Drug Administration (FDA) has accepted the BLA and granted it Priority Review status, with a target action date set for August 31, 2025. This development marks a potential milestone for Capricor, as deramiocel could become the first approved therapy specifically targeting DMD cardiomyopathy. The submission is supported by data from Phase 2 clinical trials and has received Orphan Drug Designation from both the FDA and the European Medicines Agency (EMA). Additionally, Capricor has completed its rolling BLA submission, triggering a $10 million milestone payment from its partner, Nippon Shinyaku. Analysts at H.C. Wainwright and Jones Trading have maintained their Buy ratings, with price targets of $77.00 and $40.00, respectively, reflecting confidence in the company’s progress. Despite a recent FDA warning letter unrelated to deramiocel, Jones Trading believes the market reaction was exaggerated and remains optimistic about the therapy’s approval prospects. Capricor is actively preparing for commercialization, expanding manufacturing capabilities, and forming strategic partnerships to support deramiocel’s market introduction.

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