Capricor Therapeutics Deramiocel Application Resumes FDA Review
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 1 day ago
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Should l Buy CAPR?
Capricor Therapeutics announced that the U.S. Food and Drug Administration has lifted the previously issued Complete Response Letter and resumed review of its Biologics License Application seeking full approval of Deramiocel, an investigational cell therapy, for the treatment of Duchenne muscular dystrophy cardiomyopathy. The submission has been classified as a Class 2 resubmission, with a Prescription Drug User Fee Act target action date of August 22, 2026. The Company received a Complete Response Letter from the FDA in July 2025. Following submission of data and supporting documentation from the HOPE-3 clinical trial, the FDA resumed review of the application and assigned a PDUFA target action date of August 22, 2026. At this time, the FDA has not identified any potential review issues in its response to the Company. Capricor also expects to be eligible to receive a Priority Review Voucher upon potential approval of Deramiocel.
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Analyst Views on CAPR
Wall Street analysts forecast CAPR stock price to rise
7 Analyst Rating
7 Buy
0 Hold
0 Sell
Strong Buy
Current: 33.400
Low
45.00
Averages
51.57
High
60.00
Current: 33.400
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.
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See More
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- Strong Stock Rebound: Capricor's shares surged from a 52-week low of $4.60 in December 2025 to approximately $35.80 by March 2026, demonstrating robust market demand and investor confidence, nearing its 52-week high.
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See More
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- Stock Performance: Capricor's shares rose by 11% following a review of the company's drug for muscle-wasting conditions.
- Drug Review Impact: The positive market reaction is attributed to the favorable assessment of Capricor's treatment, which targets specific health issues.
See More
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- Target Action Date: The target action date for the drug Deramciclus has been set for August 22, 2026.
- Company Involved: The announcement pertains to Capricor Therapeutics, which is involved in the development of this therapeutic.
See More
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- FDA Review Resumed: The FDA has lifted the Complete Response Letter for Capricor Therapeutics' Deramiocel BLA, resuming its review with a target action date of August 22, 2026, which opens significant market opportunities for the company.
- Clinical Trial Success: Deramiocel achieved its primary endpoint and all Type I error-controlled secondary endpoints in the HOPE-3 Phase 3 trial, demonstrating its potential as the first therapy to address both skeletal and cardiac manifestations of Duchenne muscular dystrophy (DMD).
- Priority Review Eligibility: The company expects to qualify for a Priority Review Voucher (PRV) upon potential approval of Deramiocel, which would expedite its market entry and enhance its competitive position in the rare disease treatment landscape.
- Significant Market Potential: DMD affects approximately 15,000 individuals in the U.S., with limited treatment options currently available; the successful launch of Deramiocel would provide new hope for patients while generating substantial economic returns for Capricor.
See More
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- FDA Review Resumed: Capricor Therapeutics announced that the review of its Biologics License Application (BLA) for the DMD cell therapy Deramiocel has resumed, marking a significant step closer to potential approval, with a target action date set for August 22, 2026.
- Clinical Trial Success: Deramiocel met its primary endpoint and all secondary endpoints in the HOPE-3 Phase 3 trial, demonstrating its efficacy in treating DMD cardiomyopathy, potentially making it the first therapy to address the full spectrum of the disease.
- Positive Market Reaction: Following the announcement, Capricor's stock surged 17%, reflecting strong investor confidence in the therapy, with sentiment on Stocktwits shifting from 'bullish' to 'extremely bullish', indicating optimistic expectations for its future performance.
- Potential for Priority Review: Should Deramiocel receive FDA approval, Capricor expects to qualify for a Priority Review Voucher (PRV), which would further expedite its market introduction and enhance the company's competitive position in the DMD treatment landscape.
See More
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- Stock Price Rally: Following the earnings report, NIO shares surged 10.6% to $5.47, reflecting investor optimism regarding the company's future growth prospects and potentially attracting more institutional investor interest.
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See More
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- FDA Lifts Response Letter: Capricor Therapeutics has had its Complete Response Letter lifted by the FDA after submitting data from the HOPE-3 trial, marking a significant advancement in its treatment for Duchenne muscular dystrophy.
- Clinical Trial Success: Deramiocel achieved positive results in the HOPE-3 trial, meeting the primary endpoint and all Type I error-controlled secondary endpoints, indicating its potential to be the first treatment addressing both skeletal and cardiac complications of this rare disorder.
- Strong Stock Rebound: Capricor's shares surged from a 52-week low of $4.60 in December 2025 to approximately $35.80 by March 2026, demonstrating robust market demand and investor confidence, nearing its 52-week high.
- Momentum Rating Boost: Benzinga's Edge Rankings show Capricor scoring 98.75/100 in the momentum category, further reflecting strong investor interest and a bullish trend in the stock.
See More
