On Thursday, H.C. Wainwright affirmed its Buy rating and $40.00 stock price target for Capricor Therapeutics (NASDAQ:CAPR), coinciding with the company's announcement of a rolling Biologics License Application (BLA) submission to the FDA for deramiocel, intended to treat DMD cardiomyopathy.
The analyst's positive stance is bolstered by Capricor's recent initiation of the BLA submission process, which began on October 9. The submission is based on cardiac data from the Phase 2 HOPE-2 and HOPE-2 OLE studies, and compared against natural history data from Vanderbilt University Medical Center and Cincinnati Children's Hospital Medical Center.
The company has highlighted the potential of deramiocel to offer significant clinical benefits and safety, noting the absence of approved products for DMD cardiomyopathy. The therapy is seen as a considerable advancement in the treatment of this condition. Capricor has also indicated that the BLA for deramiocel may qualify for priority review by the FDA.
Capricor anticipates the completion of the BLA submission for deramiocel in the fourth quarter of 2024. Following the completion of the rolling BLA submission, the FDA is expected to inform the company of the formal acceptance for review. The company is looking forward to a potential Prescription Drug User Fee Act (PDUFA) date in the second half of 2025.
In other recent news, Capricor Therapeutics has initiated the rolling submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for its product candidate deramiocel, a treatment for cardiomyopathy in Duchenne muscular dystrophy (DMD) patients.
The company plans to complete the submission process by the end of 2024. Capricor reported a net loss of approximately $11 million for Q2 2024, while generating revenues of around $4 million. However, the company maintains a strong cash position of $29.5 million, supported by a financial agreement with Nippon Shinyaku, totaling up to $35 million.
Analysts from Oppenheimer have sustained an Outperform rating for Capricor, while Maxim Group has maintained Buy ratings. In addition, Capricor is preparing for potential label expansion to address DMD skeletal muscle myopathy and is in advanced partnership discussions for distribution in Europe. These are some of the recent developments at Capricor Therapeutics.
InvestingPro Insights
Capricor Therapeutics' recent announcement of its rolling BLA submission for deramiocel has caught the attention of investors and analysts alike. InvestingPro data reveals some interesting insights that complement the company's recent developments.
Despite the positive news, InvestingPro Tips caution that Capricor suffers from weak gross profit margins and is not expected to be profitable this year. This aligns with the company's current focus on research and development, which often involves significant expenses before a product reaches the market.
However, it is worth noting that Capricor has shown strong market performance. The company's stock has demonstrated a remarkable 507.37% price total return over the past year, and a 304.44% return in just the last month. This surge likely reflects investor optimism about deramiocel's potential and the progress of the BLA submission.
The company's market capitalization stands at $611.69 million, indicating significant investor interest. However, with a Price to Book ratio of 53.18, the stock appears to be trading at a premium compared to its book value.
These insights provide a broader context for Capricor's current position as it navigates the regulatory process for deramiocel. Investors seeking a more comprehensive analysis can find 13 additional InvestingPro Tips for Capricor Therapeutics, offering a deeper understanding of the company's financial health and market position.
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