Capricor Reports Loss, Awaits FDA Decision on Deramiocel
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 1 hour ago
0mins
Should l Buy CAPR?
Source: stocktwits
- Poor Financial Performance: Capricor reported a net loss of $0.62 per share for Q4 2025, significantly higher than the $0.16 loss in the same quarter of 2024 and exceeding Wall Street's estimate of a $0.54 loss, indicating increasing financial pressure on the company.
- Cash Reserves Situation: As of 2025, the company holds approximately $318.1 million in cash, cash equivalents, and marketable securities, and despite reporting no revenue, management believes this is sufficient to cover anticipated expenses and capital needs through 2027, reflecting a degree of financial stability.
- FDA Decision Anticipation: Capricor is awaiting the FDA's decision on Deramiocel, expected by August 22, 2026; if approved, the company’s San Diego GMP manufacturing facility will support a potential commercial launch, marking significant progress in the treatment of DMD.
- Market Sentiment Optimism: Despite the reported losses, retail sentiment around CAPR stock on Stocktwits remains in the 'extremely bullish' territory, with the stock gaining about 156% over the past 12 months, indicating strong market confidence in its future potential.
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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: 33.570
Low
45.00
Averages
51.57
High
60.00
Current: 33.570
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 Stock Jumps 11% Following FDA's Resumption of Review for Muscle-Wasting Drug
- 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
Capricor Therapeutics Inc. Announces PDUFA Target Action Date for DeramioCel on August 22, 2026
- 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
Deramiocel Poised to Be First Therapy for DMD's Cardiac and Skeletal Issues
- 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
Capricor (CAPR) Q4 2025 Earnings Call Transcript
See More
Capricor Therapeutics Q4 2025 Earnings Call Insights
- FDA Review Progress: Capricor's biologics license application for Deramiocel has been accepted by the FDA, with a target decision date set for August 22, 2026, marking a significant milestone in the treatment of Duchenne muscular dystrophy, and if approved, it will be the first therapy addressing both skeletal and cardiac manifestations.
- Clinical Trial Results: The HOPE-3 pivotal Phase III trial demonstrated a 91% slowing of disease progression in all evaluable patients, not only validating the efficacy of Deramiocel but also laying a solid foundation for future market launch, enhancing the company's position in the competitive biopharmaceutical landscape.
- Strong Financial Position: As of December 31, 2025, Capricor reported cash and cash equivalents totaling approximately $318.1 million, which is expected to support operations into the fourth quarter of 2027, showcasing robust financial resilience and growth potential.
- Commercial Readiness and Expansion: The company is actively advancing commercial preparations for Deramiocel, including market access and patient support plans, while also planning to expand manufacturing capacity by late 2027 to meet anticipated market demand, further strengthening its competitive edge.
See More
Capricor Reports Loss, Awaits FDA Decision on Deramiocel
- Poor Financial Performance: Capricor reported a net loss of $0.62 per share for Q4 2025, significantly higher than the $0.16 loss in the same quarter of 2024 and exceeding Wall Street's estimate of a $0.54 loss, indicating increasing financial pressure on the company.
- Cash Reserves Situation: As of 2025, the company holds approximately $318.1 million in cash, cash equivalents, and marketable securities, and despite reporting no revenue, management believes this is sufficient to cover anticipated expenses and capital needs through 2027, reflecting a degree of financial stability.
- FDA Decision Anticipation: Capricor is awaiting the FDA's decision on Deramiocel, expected by August 22, 2026; if approved, the company’s San Diego GMP manufacturing facility will support a potential commercial launch, marking significant progress in the treatment of DMD.
- Market Sentiment Optimism: Despite the reported losses, retail sentiment around CAPR stock on Stocktwits remains in the 'extremely bullish' territory, with the stock gaining about 156% over the past 12 months, indicating strong market confidence in its future potential.
See More
Capricor Stock Jumps 11% Following FDA's Resumption of Review for Muscle-Wasting Drug
- 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
Capricor Therapeutics Inc. Announces PDUFA Target Action Date for DeramioCel on August 22, 2026
- 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
Deramiocel Poised to Be First Therapy for DMD's Cardiac and Skeletal Issues
- 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
Capricor (CAPR) Q4 2025 Earnings Call Transcript
See More
Capricor Therapeutics Q4 2025 Earnings Call Insights
- FDA Review Progress: Capricor's biologics license application for Deramiocel has been accepted by the FDA, with a target decision date set for August 22, 2026, marking a significant milestone in the treatment of Duchenne muscular dystrophy, and if approved, it will be the first therapy addressing both skeletal and cardiac manifestations.
- Clinical Trial Results: The HOPE-3 pivotal Phase III trial demonstrated a 91% slowing of disease progression in all evaluable patients, not only validating the efficacy of Deramiocel but also laying a solid foundation for future market launch, enhancing the company's position in the competitive biopharmaceutical landscape.
- Strong Financial Position: As of December 31, 2025, Capricor reported cash and cash equivalents totaling approximately $318.1 million, which is expected to support operations into the fourth quarter of 2027, showcasing robust financial resilience and growth potential.
- Commercial Readiness and Expansion: The company is actively advancing commercial preparations for Deramiocel, including market access and patient support plans, while also planning to expand manufacturing capacity by late 2027 to meet anticipated market demand, further strengthening its competitive edge.
See More
Capricor Reports Loss, Awaits FDA Decision on Deramiocel
- Poor Financial Performance: Capricor reported a net loss of $0.62 per share for Q4 2025, significantly higher than the $0.16 loss in the same quarter of 2024 and exceeding Wall Street's estimate of a $0.54 loss, indicating increasing financial pressure on the company.
- Cash Reserves Situation: As of 2025, the company holds approximately $318.1 million in cash, cash equivalents, and marketable securities, and despite reporting no revenue, management believes this is sufficient to cover anticipated expenses and capital needs through 2027, reflecting a degree of financial stability.
- FDA Decision Anticipation: Capricor is awaiting the FDA's decision on Deramiocel, expected by August 22, 2026; if approved, the company’s San Diego GMP manufacturing facility will support a potential commercial launch, marking significant progress in the treatment of DMD.
- Market Sentiment Optimism: Despite the reported losses, retail sentiment around CAPR stock on Stocktwits remains in the 'extremely bullish' territory, with the stock gaining about 156% over the past 12 months, indicating strong market confidence in its future potential.
See More
