Capricor schedules FDA meeting on Duchenne therapy, delays earnings

SAN DIEGO - Capricor Therapeutics (NASDAQ:CAPR), a biotechnology company with strong financial health indicators according to InvestingPro data showing more cash than debt and liquid assets exceeding short-term obligations, has scheduled a Type A meeting with the U.S. Food and Drug Administration to discuss the regulatory pathway for Deramiocel, its cell therapy candidate for Duchenne muscular dystrophy (DMD), the biotechnology company announced Friday.

Due to the FDA meeting, Capricor has rescheduled the release of its second-quarter 2025 financial results to Monday, August 11, after market close, followed by a conference call with management at 4:30 p.m. ET. The announcement comes as the stock shows mixed performance, with InvestingPro data revealing a strong 108% return over the past year despite recent monthly weakness. Investors seeking deeper insights can access comprehensive analysis through InvestingPro’s detailed research reports, available for over 1,400 US stocks including CAPR.

Deramiocel is Capricor’s lead product candidate, an allogeneic cardiac-derived cell therapy currently in late-stage development for treating cardiomyopathy associated with DMD. The company is seeking approval through a Biologics License Application (BLA).

The Type A meeting represents a critical step in Capricor’s regulatory process for Deramiocel. These meetings typically occur when there are issues with a drug application that need resolution.

Capricor is also developing exosome technology through its StealthX platform, which is in preclinical development for applications including vaccinology and targeted delivery of therapeutics.

The company has previously entered into an agreement with Nippon Shinyaku Co., Ltd. for the exclusive commercialization and distribution of Deramiocel for DMD in the United States and Japan, contingent on regulatory approval.

Deramiocel remains an investigational candidate and has not received commercial approval for any indication, according to the company’s press release statement. While the company currently shows a current ratio of 6.55 and maintains minimal debt, InvestingPro analysis indicates analysts don’t expect profitability this year. InvestingPro subscribers can access 8 additional key insights about CAPR’s financial health and market position.

In other recent news, Capricor Therapeutics received a Complete Response Letter from the U.S. Food and Drug Administration, rejecting its Biologics License Application for Deramiocel, a cell therapy for Duchenne muscular dystrophy. The FDA cited insufficient evidence of effectiveness and requested additional clinical data, along with addressing outstanding Chemistry, Manufacturing, and Controls issues. Following this, H.C. Wainwright lowered its price target for Capricor to $24.00 from $77.00, while maintaining a Buy rating. Despite this setback, Oppenheimer reiterated its Outperform rating on Capricor, maintaining a $22.00 price target, attributing recent stock weakness to external factors. Additionally, B.Riley initiated coverage with a Buy rating and a $21.00 price target, highlighting the potential of Deramiocel to address a significant unmet need in Duchenne Muscular Dystrophy-cardiomyopathy. Capricor plans to resubmit data to the FDA in response to the agency’s feedback. These developments have drawn significant attention from analysts and investors alike.

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