Capricor Prepares FDA Submission for DMD Therapy Deramiocel
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 1 hour ago
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Should l Buy CAPR?
Source: stocktwits
- FDA Submission Preparation: Capricor is preparing to submit its DMD cell therapy Deramiocel to the FDA in February, addressing issues raised in a Complete Response Letter from July 2025, indicating that the company is making significant progress in preparing the clinical study report without the need for new trials, which could expedite market entry.
- Financial Expectations: According to Koyfin estimates, Capricor is expected to report no revenue for the quarter with an EBITDA loss of $24.60 million, slightly better than the previous quarter's loss of $25.79 million, suggesting a minor improvement in financial performance that may bolster investor confidence.
- Market Sentiment: On Stocktwits, retail sentiment towards Capricor is deemed 'extremely bullish', while Sarepta faces a 'bearish' sentiment due to legal and safety concerns, reflecting divergent investor outlooks on the future prospects of the two companies, which could influence stock price volatility.
- Earnings Pressure on Sarepta: Sarepta is expected to report quarterly revenue of $390.95 million with an EBITDA loss widening to $144.34 million, facing pressures from legal lawsuits and safety issues, which may negatively impact its stock price, with analysts showing mixed sentiments regarding its outlook.
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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: 29.150
Low
45.00
Averages
51.57
High
60.00
Current: 29.150
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 Prepares FDA Submission for DMD Therapy Deramiocel
- FDA Submission Preparation: Capricor is preparing to submit its DMD cell therapy Deramiocel to the FDA in February, addressing issues raised in a Complete Response Letter from July 2025, indicating that the company is making significant progress in preparing the clinical study report without the need for new trials, which could expedite market entry.
- Financial Expectations: According to Koyfin estimates, Capricor is expected to report no revenue for the quarter with an EBITDA loss of $24.60 million, slightly better than the previous quarter's loss of $25.79 million, suggesting a minor improvement in financial performance that may bolster investor confidence.
- Market Sentiment: On Stocktwits, retail sentiment towards Capricor is deemed 'extremely bullish', while Sarepta faces a 'bearish' sentiment due to legal and safety concerns, reflecting divergent investor outlooks on the future prospects of the two companies, which could influence stock price volatility.
- Earnings Pressure on Sarepta: Sarepta is expected to report quarterly revenue of $390.95 million with an EBITDA loss widening to $144.34 million, facing pressures from legal lawsuits and safety issues, which may negatively impact its stock price, with analysts showing mixed sentiments regarding its outlook.
See More
Trump Announces Global Tariff Increase to 15%
- Tariff Increase Impact: President Trump announced a rise in global tariffs from 10% to 15%, following a Supreme Court ruling deeming the previous rate ‘anti-American’, which may exacerbate market uncertainty and affect investor confidence.
- Market Reaction: U.S. stock futures sharply declined on Monday morning, with Nasdaq futures down 0.6%, S&P 500 and Dow futures each falling 0.5%, and Russell 2000 futures nearly down 1%, indicating investor concerns over tariff hikes and geopolitical tensions.
- Retail Sentiment Shift: Retail sentiment towards the SPDR S&P 500 ETF (SPY) shifted from ‘neutral’ to ‘bearish’, while the Invesco QQQ Trust (QQQ) ETF remained ‘bearish’ amid high trading volumes, reflecting a pessimistic outlook on future market performance.
- Economic Data Watch: Investors will monitor factory orders data set to be released at 10:00 AM ET today, along with commentary from Fed Governor Christopher Wallace, as these insights could further influence market sentiment and investment strategies.
See More
Capricor's DMD Therapy Gains FDA Attention with Phase 3 Data
- Clinical Trial Progress: Capricor's Deramiocel demonstrated significant skeletal muscle and cardiac function improvements in the Phase 3 Hope-3 trial, with results from 106 participants indicating a statistically significant slowing of upper limb function decline, which is expected to advance the FDA approval process.
- FDA Review Request: The FDA requested Capricor to submit the full clinical study report from the Hope-3 trial without requiring new clinical trials, providing Capricor with an opportunity to continue the review and potentially set a new decision date.
- Stock Price Surge: Capricor's shares surged nearly 30% this week, with a single-day increase of over 14% on Thursday, reaching the highest level since December, reflecting investor optimism ahead of the upcoming FDA filing.
- Analyst Optimism: Following the release of the Hope-3 data, several Wall Street firms raised their price targets for Capricor, with B. Riley increasing its target from $21 to $50, projecting sales exceeding $1 billion by 2030, indicating a high probability of success for the drug.
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 Prepares FDA Submission for DMD Therapy Deramiocel
- FDA Submission Preparation: Capricor is preparing to submit its DMD cell therapy Deramiocel to the FDA in February, addressing issues raised in a Complete Response Letter from July 2025, indicating that the company is making significant progress in preparing the clinical study report without the need for new trials, which could expedite market entry.
- Financial Expectations: According to Koyfin estimates, Capricor is expected to report no revenue for the quarter with an EBITDA loss of $24.60 million, slightly better than the previous quarter's loss of $25.79 million, suggesting a minor improvement in financial performance that may bolster investor confidence.
- Market Sentiment: On Stocktwits, retail sentiment towards Capricor is deemed 'extremely bullish', while Sarepta faces a 'bearish' sentiment due to legal and safety concerns, reflecting divergent investor outlooks on the future prospects of the two companies, which could influence stock price volatility.
- Earnings Pressure on Sarepta: Sarepta is expected to report quarterly revenue of $390.95 million with an EBITDA loss widening to $144.34 million, facing pressures from legal lawsuits and safety issues, which may negatively impact its stock price, with analysts showing mixed sentiments regarding its outlook.
See More
Trump Announces Global Tariff Increase to 15%
- Tariff Increase Impact: President Trump announced a rise in global tariffs from 10% to 15%, following a Supreme Court ruling deeming the previous rate ‘anti-American’, which may exacerbate market uncertainty and affect investor confidence.
- Market Reaction: U.S. stock futures sharply declined on Monday morning, with Nasdaq futures down 0.6%, S&P 500 and Dow futures each falling 0.5%, and Russell 2000 futures nearly down 1%, indicating investor concerns over tariff hikes and geopolitical tensions.
- Retail Sentiment Shift: Retail sentiment towards the SPDR S&P 500 ETF (SPY) shifted from ‘neutral’ to ‘bearish’, while the Invesco QQQ Trust (QQQ) ETF remained ‘bearish’ amid high trading volumes, reflecting a pessimistic outlook on future market performance.
- Economic Data Watch: Investors will monitor factory orders data set to be released at 10:00 AM ET today, along with commentary from Fed Governor Christopher Wallace, as these insights could further influence market sentiment and investment strategies.
See More
Capricor's DMD Therapy Gains FDA Attention with Phase 3 Data
- Clinical Trial Progress: Capricor's Deramiocel demonstrated significant skeletal muscle and cardiac function improvements in the Phase 3 Hope-3 trial, with results from 106 participants indicating a statistically significant slowing of upper limb function decline, which is expected to advance the FDA approval process.
- FDA Review Request: The FDA requested Capricor to submit the full clinical study report from the Hope-3 trial without requiring new clinical trials, providing Capricor with an opportunity to continue the review and potentially set a new decision date.
- Stock Price Surge: Capricor's shares surged nearly 30% this week, with a single-day increase of over 14% on Thursday, reaching the highest level since December, reflecting investor optimism ahead of the upcoming FDA filing.
- Analyst Optimism: Following the release of the Hope-3 data, several Wall Street firms raised their price targets for Capricor, with B. Riley increasing its target from $21 to $50, projecting sales exceeding $1 billion by 2030, indicating a high probability of success for the drug.
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
