Capricor Therapeutics Updates Deramiocel Application Progress
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jan 20 2026
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Capricor Therapeutics provided a regulatory update regarding its Biologics License Application, BLA, for Deramiocel, the Company's investigational first-in-class cell therapy for the treatment of Duchenne muscular dystrophy, DMD. As previously disclosed, the Company provided topline results from its Phase 3 HOPE-3 clinical study to the U.S. Food and Drug Administration, FDA, in late 2025. Following its review of these data, the FDA has formally requested the full HOPE-3 clinical study report, CSR, and supporting data to address the Complete Response Letter, CRL. The FDA did not request any additional clinical studies or new patient data as part of this request. Preparation of the HOPE-3 CSR is well underway, and the Company plans to submit the requested materials to the FDA in February 2026. The Company expects that this submission will address the items outlined in the CRL and support continued review of the BLA, including the assignment of a new Prescription Drug User Fee Act target action date.
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Analyst Views on CAPR
Wall Street analysts forecast CAPR stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for CAPR is 51.57 USD with a low forecast of 45.00 USD and a high forecast of 60.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
7 Analyst Rating
7 Buy
0 Hold
0 Sell
Strong Buy
Current: 21.570
Low
45.00
Averages
51.57
High
60.00
Current: 21.570
Low
45.00
Averages
51.57
High
60.00
About CAPR
Capricor Therapeutics, Inc. is a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment and prevention of rare diseases. The Company's program is focused on the development and commercialization of a cell therapy technology comprised of cardiosphere-derived cells (CDCs) for the treatment of Duchenne muscular dystrophy (DMD). Its lead product candidate deramiocel (also referred to as CAP-1002), is an allogeneic cardiac-derived cell therapy. CAP-1002 is advancing through Phase III clinical development for the treatment of Duchenne muscular dystrophy (DMD). CAP-1002 demonstrates immunomodulatory, antifibrotic, and regenerative actions specifically tailored for dystrophinopathies and heart disease. It leverages its exosome technology, using its StealthX platform in preclinical development focused on the areas of vaccinology, targeted delivery of oligonucleotides, proteins, and small molecule therapeutics.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Capricor (CAPR) Plans February FDA Data Submission After 2% Stock Drop
- FDA Data Request: Capricor Therapeutics announced that the FDA has requested the full HOPE-3 clinical study report without asking for additional clinical studies or new patient data, providing the company an opportunity to advance its application.
- Clinical Trial Progress: Although the FDA rejected the Deramiocel application in July due to insufficient evidence of effectiveness, the results from the December HOPE-3 study indicated significant improvements in muscle and heart function, which may help meet the FDA's requirements.
- Future Plans: Capricor plans to submit the requested data to the FDA in February, expecting that this will support the continued review of its application and address the concerns raised by the FDA in July, aiming to provide faster treatment options for late-stage DMD patients.
- Market Reaction: Despite a 2% drop in Capricor's stock on Tuesday morning, the stock has gained 69% over the past 12 months, reflecting some market optimism regarding the approval of Deramiocel, although overall retail sentiment remains bearish.
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Capricor Therapeutics Achieves Phase 3 Trial Success for DMD Therapy, Stock Soars 439.4%
- Phase 3 Trial Success: Capricor Therapeutics' Deramiocel met its primary and secondary endpoints in the Phase 3 HOPE-3 trial, significantly slowing upper limb functional decline by 54% and left ventricular ejection fraction decline by 91%, offering hope for DMD patients.
- Future Outlook: With FDA approval anticipated in 2026, Deramiocel could generate up to $1.5 billion in milestone payments, indicating the substantial market value of this therapy.
- Successful Financing: Following the announcement, the company raised $150 million in a public offering, providing crucial funding for further research and market launch, thereby boosting investor confidence.
- Market Potential: With approximately 200,000 global DMD patients, Capricor's commercialization agreement with Nippon Shinyaku highlights its strategic positioning in the U.S., Japan, and European markets.
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