Positive Outlook for Capricor as They Prepare to Address Complete Response Letter
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 04 2025
0mins
Should l Buy CAPR?
Source: NASDAQ.COM
Positive Trial Results: Capricor Therapeutics reported successful topline results from its Phase 3 HOPE-3 trial of Deramiocel, showing a 54% slowing of skeletal muscle disease progression in Duchenne Muscular Dystrophy (DMD) patients and a 91% slowing of decline in left ventricular ejection fraction.
Safety and Efficacy: Deramiocel demonstrated a favorable safety profile and achieved statistical significance in both primary and secondary endpoints, reinforcing its potential benefits for muscle and heart function in DMD patients.
Regulatory Plans: Capricor plans to submit the HOPE-3 data to the FDA in response to a Complete Response Letter issued earlier, aiming for regulatory approval of Deramiocel, which has already received Orphan Drug and RMAT designations.
Stock Performance: Following the trial results, Capricor's stock price surged significantly, closing at $29.96 after reaching an intraday high of $40.37, reflecting a 371% increase.
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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: 23.670
Low
45.00
Averages
51.57
High
60.00
Current: 23.670
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.
See More
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.
See More
Capricor Therapeutics Stock Soars 439.4% Following Positive Phase 3 Trial Results for DMD Treatment
- Stock Surge: Capricor Therapeutics experienced a remarkable 439.4% stock increase in December, reflecting strong market confidence in its DMD treatment, Deramiocel, and highlighting investor enthusiasm for biotech advancements.
- Clinical Trial Success: The Phase 3 HOPE-3 trial met both primary and secondary endpoints, demonstrating a 54% reduction in upper limb functional decline and a 91% decrease in left ventricular ejection fraction decline, establishing a solid foundation for the drug's market potential.
- Funding and Partnerships: Following the announcement, the company raised $150 million and signed a commercialization agreement with Japanese pharmaceutical firm Nippon Shinyaku, with potential milestones totaling $1.5 billion, indicating high market recognition for the therapy.
- FDA Approval Outlook: Although the FDA did not approve its Biologics License Application in July, the company plans to submit a new application in 2026 incorporating HOPE-3 data, with management expressing confidence in securing approval, suggesting promising commercialization opportunities ahead.
See More
Capricor Announces Webinar on Positive HOPE-3 Trial Results for DMD Treatment
- Clinical Trial Progress: Capricor Therapeutics announced a webinar on December 17, 2025, to share positive topline results from its HOPE-3 trial for Duchenne muscular dystrophy (DMD), which is expected to attract significant interest from patients and families.
- Regulatory Discussion Update: The webinar will discuss how the HOPE-3 results inform ongoing regulatory discussions with the U.S. Food and Drug Administration (FDA), potentially accelerating the approval process for DMD treatments.
- Product Candidate Introduction: Capricor's lead product candidate, Deramiocel, is an allogeneic cardiac-derived cell therapy that has shown significant immunomodulatory and anti-fibrotic effects in clinical development, aimed at improving cardiac and skeletal muscle function in DMD patients.
- Technological Platform Advantage: Capricor is also leveraging its proprietary StealthX™ platform for preclinical development focused on vaccinology and targeted drug delivery, showcasing its potential to treat a wide range of diseases and further solidifying its innovative position in the biotechnology sector.
See More
Capricor Announces Webinar on Positive HOPE-3 Trial Results for DMD Treatment
- Clinical Trial Progress: Capricor Therapeutics announced positive topline results from its HOPE-3 trial for Deramiocel, a treatment for DMD, which is expected to facilitate ongoing regulatory discussions with the FDA, potentially providing more effective treatment options for patients.
- Webinar Announcement: PPMD will host a webinar on December 17, 2025, to share HOPE-3 trial results, encouraging patients and families to submit questions in advance, thereby enhancing patient engagement and increasing the company's influence within the patient community.
- Technological Innovation: Deramiocel is an allogeneic cardiac-derived cell therapy that has demonstrated significant immunomodulatory and anti-fibrotic effects in clinical development, aimed at improving cardiac and skeletal muscle function in DMD patients, indicating substantial market potential.
- Strategic Partnership: Capricor has entered into an exclusive commercialization agreement with Nippon Shinyaku Co., Ltd. for Deramiocel in the U.S. and Japan, which, pending regulatory approval, will further expand its international market presence.
See More
Martin Shkreli's Biotech Short Bet Faces Major Loss as Stock Rises 440%: Momentum Score Surges
Martin Shkreli's Short Position: Martin Shkreli, known as "Pharma bro," has taken a short position against Capricor Therapeutics, betting against their HOPE-3 cell therapy for Duchenne Muscular Dystrophy, which he claims will fail.
Stock Rally After Positive Results: Following a major regulatory milestone and positive results from the HOPE-3 trial, Capricor's stock surged 440% in one day, significantly impacting Shkreli's short position.
Momentum Score Surge: The stock's Momentum score in Benzinga’s Edge Rankings skyrocketed from 3.83 to 96.4 within a week, indicating a substantial increase in trading volume and volatility.
Shkreli's Response: In response to the stock's performance, Shkreli has criticized the trial data and accused Capricor's CEO of misrepresenting the results, despite the stock's favorable price trends.
See More
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.
See More
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.
See More
Capricor Therapeutics Stock Soars 439.4% Following Positive Phase 3 Trial Results for DMD Treatment
- Stock Surge: Capricor Therapeutics experienced a remarkable 439.4% stock increase in December, reflecting strong market confidence in its DMD treatment, Deramiocel, and highlighting investor enthusiasm for biotech advancements.
- Clinical Trial Success: The Phase 3 HOPE-3 trial met both primary and secondary endpoints, demonstrating a 54% reduction in upper limb functional decline and a 91% decrease in left ventricular ejection fraction decline, establishing a solid foundation for the drug's market potential.
- Funding and Partnerships: Following the announcement, the company raised $150 million and signed a commercialization agreement with Japanese pharmaceutical firm Nippon Shinyaku, with potential milestones totaling $1.5 billion, indicating high market recognition for the therapy.
- FDA Approval Outlook: Although the FDA did not approve its Biologics License Application in July, the company plans to submit a new application in 2026 incorporating HOPE-3 data, with management expressing confidence in securing approval, suggesting promising commercialization opportunities ahead.
See More
Capricor Announces Webinar on Positive HOPE-3 Trial Results for DMD Treatment
- Clinical Trial Progress: Capricor Therapeutics announced a webinar on December 17, 2025, to share positive topline results from its HOPE-3 trial for Duchenne muscular dystrophy (DMD), which is expected to attract significant interest from patients and families.
- Regulatory Discussion Update: The webinar will discuss how the HOPE-3 results inform ongoing regulatory discussions with the U.S. Food and Drug Administration (FDA), potentially accelerating the approval process for DMD treatments.
- Product Candidate Introduction: Capricor's lead product candidate, Deramiocel, is an allogeneic cardiac-derived cell therapy that has shown significant immunomodulatory and anti-fibrotic effects in clinical development, aimed at improving cardiac and skeletal muscle function in DMD patients.
- Technological Platform Advantage: Capricor is also leveraging its proprietary StealthX™ platform for preclinical development focused on vaccinology and targeted drug delivery, showcasing its potential to treat a wide range of diseases and further solidifying its innovative position in the biotechnology sector.
See More
Capricor Announces Webinar on Positive HOPE-3 Trial Results for DMD Treatment
- Clinical Trial Progress: Capricor Therapeutics announced positive topline results from its HOPE-3 trial for Deramiocel, a treatment for DMD, which is expected to facilitate ongoing regulatory discussions with the FDA, potentially providing more effective treatment options for patients.
- Webinar Announcement: PPMD will host a webinar on December 17, 2025, to share HOPE-3 trial results, encouraging patients and families to submit questions in advance, thereby enhancing patient engagement and increasing the company's influence within the patient community.
- Technological Innovation: Deramiocel is an allogeneic cardiac-derived cell therapy that has demonstrated significant immunomodulatory and anti-fibrotic effects in clinical development, aimed at improving cardiac and skeletal muscle function in DMD patients, indicating substantial market potential.
- Strategic Partnership: Capricor has entered into an exclusive commercialization agreement with Nippon Shinyaku Co., Ltd. for Deramiocel in the U.S. and Japan, which, pending regulatory approval, will further expand its international market presence.
See More
Martin Shkreli's Biotech Short Bet Faces Major Loss as Stock Rises 440%: Momentum Score Surges
Martin Shkreli's Short Position: Martin Shkreli, known as "Pharma bro," has taken a short position against Capricor Therapeutics, betting against their HOPE-3 cell therapy for Duchenne Muscular Dystrophy, which he claims will fail.
Stock Rally After Positive Results: Following a major regulatory milestone and positive results from the HOPE-3 trial, Capricor's stock surged 440% in one day, significantly impacting Shkreli's short position.
Momentum Score Surge: The stock's Momentum score in Benzinga’s Edge Rankings skyrocketed from 3.83 to 96.4 within a week, indicating a substantial increase in trading volume and volatility.
Shkreli's Response: In response to the stock's performance, Shkreli has criticized the trial data and accused Capricor's CEO of misrepresenting the results, despite the stock's favorable price trends.
See More
