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H.C. Wainwright reiterated its Buy rating and $77.00 price target on Capricor Therapeutics (NASDAQ:CAPR) Monday despite recent regulatory uncertainty surrounding the company’s lead drug candidate. According to InvestingPro data, analysts maintain a strong buy consensus with price targets ranging from $25 to $77, suggesting significant upside potential from current levels.
The FDA sent a letter to the Federal Register withdrawing its notice regarding an Advisory Committee meeting for deramiocel, which had been scheduled for July 30 ahead of the August 31 PDUFA date. The letter concluded with the statement, "The FDA requires additional time regarding this notice prior to its publication."
Capricor has not received any direct notice from the FDA regarding changes to the Advisory Committee meeting as of Monday, according to H.C. Wainwright. The firm noted this appears to be an administrative action by the FDA following recent personnel changes at the agency.
The research firm maintained its positive outlook on deramiocel’s approval prospects despite the regulatory uncertainty. H.C. Wainwright characterized market reactions to the FDA’s notice withdrawal as an "overreaction" to the news.
Deramiocel is Capricor’s investigational therapy being evaluated for potential approval, with its scheduled regulatory decision date remaining August 31, according to the available information. InvestingPro analysis reveals the company maintains a strong financial position with a healthy current ratio of 6.55 and more cash than debt on its balance sheet. InvestingPro subscribers can access 12 additional key insights about CAPR’s valuation and growth prospects through the comprehensive Pro Research Report.
In other recent news, Capricor Therapeutics has reported a wider-than-expected loss for the first quarter of 2025, with earnings per share at -$0.53, missing the forecasted -$0.32. The company also saw a significant drop in revenue, recording $0 compared to $4.9 million in the same period last year. Despite these financial setbacks, Capricor maintains a strong cash position with $144.8 million on hand. In regulatory developments, the FDA completed a Pre-License Inspection of Capricor’s San Diego manufacturing facility for its Duchenne Muscular Dystrophy therapy, Deramiocel, resulting in a Form 483 with observations related to quality systems and documentation practices. None of these observations required material changes to the manufacturing process. Additionally, Roth/MKM has initiated coverage of Capricor with a Buy rating and a $31 price target, citing the potential of Deramiocel to enhance cardiac and skeletal muscle function in DMD patients. Capricor also announced the adoption of a 2025 Equity Incentive Plan, reserving 3.5 million shares for equity-based awards to employees, directors, and consultants.
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