Capricor's Biologics License Application Progress
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jun 26 2026
0mins
Source: Newsfilter
- Advisory Committee Meeting Scheduled: The FDA plans to hold an Advisory Committee meeting on July 29, 2026, to discuss Capricor's Biologics License Application (BLA) for Deramiocel, a cell therapy aimed at treating Duchenne muscular dystrophy, marking a significant advancement in the company's efforts to address rare diseases.
- Clinical Trial Support: The BLA is backed by the long-term outcomes from the company's HOPE-2 trial and HOPE-2-OLE trial, while the HOPE-3 trial achieved statistical significance on its primary endpoint (PUL v2.0) and key secondary cardiac endpoint (LVEF), demonstrating the efficacy of Deramiocel.
- Significant Therapeutic Potential: As a first-in-class therapy, Deramiocel has shown clinically meaningful and statistically significant benefits in skeletal and cardiac functions across multiple studies, with a consistent safety profile, indicating its substantial potential in treating Duchenne muscular dystrophy.
- Regulatory Support and Market Outlook: Deramiocel has received Orphan Drug Designation from both the FDA and EMA, along with Regenerative Medicine Advanced Therapy (RMAT) designation in the U.S., highlighting its competitive edge and future approval potential, which may qualify Capricor for a Priority Review Voucher.
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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: 23.210
Low
45.00
Averages
51.57
High
60.00
Current: 23.210
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 focuses 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. The clinical development program for Deramiocel has focused primarily on adolescents and young adults with DMD, including many patients who are non-ambulatory and experiencing progressive cardiac and skeletal muscle decline. Its StealthX exosome platform program consists of engineered exosomes for vaccine and therapeutic development. The StealthX vaccine is a proprietary vaccine developed internally utilizing exosomes that were engineered to express either spike or nucleocapsid proteins on the surface.
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 Executives Sell $1.46 Million in Shares Ahead of FDA Review
- Executive Stock Sales: CFO Anthony Bergmann and legal chief Karen Krasney sold approximately 48,200 shares for about $1.46 million on June 25, indicating a cautious outlook from executives that may impact investor confidence in Capricor's future prospects.
- FDA Review Approaches: Capricor's DMD therapy, Deramiocel, is set for an FDA panel review on July 29, with its Biologics License Application supported by positive data from the Hope-2 and Hope-3 trials, which could significantly influence the company's future trajectory if approved.
- Positive Clinical Trial Results: Capricor reported that patients treated with Deramiocel experienced less than a 5-point decline in upper-limb function over five years, compared to an expected 12-point decline in a matched control group, showcasing the drug's potential to slow DMD progression and possibly boosting market confidence.
- Market Sentiment Shift: Retail sentiment for CAPR on Stocktwits surged from 'bullish' to 'extremely bullish' amid a 592% increase in message volume within 24 hours, reflecting investor optimism regarding the upcoming FDA review outcomes.
See More
Capricor Advances Biologics License Application for DMD Treatment
- FDA Advisory Meeting Scheduled: The U.S. FDA's Cellular, Tissue, and Gene Therapies Advisory Committee plans to meet on July 29, 2026, to discuss Capricor's Biologics License Application (BLA) for Deramiocel aimed at treating Duchenne muscular dystrophy (DMD), providing the company with a direct engagement opportunity with the FDA that could expedite the approval process.
- Impressive Five-Year Study Data: The ongoing HOPE-2 Open-Label Extension study shows that Deramiocel offers durable skeletal and cardiac muscle benefits over five years, with the year-over-year decline in PUL 2.0 attenuated to approximately 1 point, indicating its potential to improve patient quality of life and enhance market competitiveness.
- Stability in Cardiac Function: The study reveals that Deramiocel maintains stable left ventricular ejection fraction (LVEF) over five years, contrasting with a modeled decline of about 3.2% per year in a propensity-matched external cardiac comparator, suggesting its effectiveness in cardiac protection, which may attract more investor interest.
- Favorable Safety Profile: The five-year HOPE-2 OLE study reports no new safety signals for Deramiocel, demonstrating a favorable safety profile that could enhance confidence among physicians and patients, thereby driving market acceptance of the product.
See More
Restaurant Brands International Options Volume Surges
- Surge in Options Volume: Restaurant Brands International (QSR) has seen an options volume of 27,631 contracts today, equating to approximately 2.8 million shares, which represents a significant 76.2% of its average daily trading volume over the past month.
- High-Frequency Contracts: Notably, the $75 strike call option expiring on July 17, 2026, has traded 16,523 contracts today, representing about 1.7 million shares, indicating strong market interest at this price point.
- CAPR Options Activity: In parallel, Capricor Therapeutics (CAPR) has recorded an options volume of 7,668 contracts today, approximately 766,800 shares, which constitutes 75.2% of its average daily trading volume over the past month, highlighting investor attention on the company.
- Put Option Trading: The $20 strike put option expiring on August 21, 2026, has seen a trading volume of 5,735 contracts today, representing around 573,500 shares, reflecting a cautious market sentiment regarding CAPR's future performance.
See More
Capricor's Hope-2 Study Shows Stable Efficacy Over Five Years
- Efficacy Sustained: Capricor Therapeutics' Hope-2 extension study demonstrated that Deramiocel continued to slow disease progression over five years, with patients showing less decline in upper limb function than expected, indicating the therapy's long-term effectiveness and safety.
- Stable Cardiac Function: Throughout the study, Deramiocel maintained stable cardiac function, and no new safety concerns were reported after over 800 intravenous infusions, showcasing a favorable safety profile.
- FDA Review Progress: Capricor confirmed that its Biologics License Application (BLA) remains on track for the Prescription Drug User Fee Act (PDUFA) target action date of August 22, 2026, reflecting the company's confidence in market access.
- Market Sentiment Shift: Despite CAPR stock dropping 11% at the time of writing, retail sentiment on Stocktwits shifted from 'bullish' to 'extremely bullish', indicating heightened investor interest in the upcoming FDA advisory committee meeting.
See More
Capricor's Deramiocel BLA Under FDA Review for Duchenne Muscular Dystrophy
- FDA Advisory Meeting Scheduled: The U.S. FDA's Cellular, Tissue, and Gene Therapies Advisory Committee will meet on July 29, 2026, to discuss Capricor Therapeutics' Biologics License Application (BLA) for Deramiocel aimed at treating Duchenne muscular dystrophy (DMD).
- Clinical Trial Support: The BLA is backed by data from the Phase 2 HOPE-2 trial, long-term follow-up from the HOPE-2 open-label extension study, and positive outcomes from the Phase 3 HOPE-3 trial, which achieved its primary endpoint of Performance of Upper Limb (PUL) and key secondary endpoint of left ventricular ejection fraction (LVEF).
- Drug Designations: Deramiocel (CAP-1002) has received Orphan Drug Designation from both the FDA and EMA, along with Regenerative Medicine Advanced Therapy (RMAT) designation in the U.S., indicating its potential in DMD treatment and eligibility for a Priority Review Voucher upon approval.
- Market Reaction: Despite the positive progress of Deramiocel's application, Capricor's stock has declined by 12.11% to $26.72, reflecting market caution regarding the drug's future success.
See More
Capricor's Biologics License Application Progress
- Advisory Committee Meeting Scheduled: The FDA plans to hold an Advisory Committee meeting on July 29, 2026, to discuss Capricor's Biologics License Application (BLA) for Deramiocel, a cell therapy aimed at treating Duchenne muscular dystrophy, marking a significant advancement in the company's efforts to address rare diseases.
- Clinical Trial Support: The BLA is backed by the long-term outcomes from the company's HOPE-2 trial and HOPE-2-OLE trial, while the HOPE-3 trial achieved statistical significance on its primary endpoint (PUL v2.0) and key secondary cardiac endpoint (LVEF), demonstrating the efficacy of Deramiocel.
- Significant Therapeutic Potential: As a first-in-class therapy, Deramiocel has shown clinically meaningful and statistically significant benefits in skeletal and cardiac functions across multiple studies, with a consistent safety profile, indicating its substantial potential in treating Duchenne muscular dystrophy.
- Regulatory Support and Market Outlook: Deramiocel has received Orphan Drug Designation from both the FDA and EMA, along with Regenerative Medicine Advanced Therapy (RMAT) designation in the U.S., highlighting its competitive edge and future approval potential, which may qualify Capricor for a Priority Review Voucher.
See More
Capricor Executives Sell $1.46 Million in Shares Ahead of FDA Review
- Executive Stock Sales: CFO Anthony Bergmann and legal chief Karen Krasney sold approximately 48,200 shares for about $1.46 million on June 25, indicating a cautious outlook from executives that may impact investor confidence in Capricor's future prospects.
- FDA Review Approaches: Capricor's DMD therapy, Deramiocel, is set for an FDA panel review on July 29, with its Biologics License Application supported by positive data from the Hope-2 and Hope-3 trials, which could significantly influence the company's future trajectory if approved.
- Positive Clinical Trial Results: Capricor reported that patients treated with Deramiocel experienced less than a 5-point decline in upper-limb function over five years, compared to an expected 12-point decline in a matched control group, showcasing the drug's potential to slow DMD progression and possibly boosting market confidence.
- Market Sentiment Shift: Retail sentiment for CAPR on Stocktwits surged from 'bullish' to 'extremely bullish' amid a 592% increase in message volume within 24 hours, reflecting investor optimism regarding the upcoming FDA review outcomes.
See More
Capricor Advances Biologics License Application for DMD Treatment
- FDA Advisory Meeting Scheduled: The U.S. FDA's Cellular, Tissue, and Gene Therapies Advisory Committee plans to meet on July 29, 2026, to discuss Capricor's Biologics License Application (BLA) for Deramiocel aimed at treating Duchenne muscular dystrophy (DMD), providing the company with a direct engagement opportunity with the FDA that could expedite the approval process.
- Impressive Five-Year Study Data: The ongoing HOPE-2 Open-Label Extension study shows that Deramiocel offers durable skeletal and cardiac muscle benefits over five years, with the year-over-year decline in PUL 2.0 attenuated to approximately 1 point, indicating its potential to improve patient quality of life and enhance market competitiveness.
- Stability in Cardiac Function: The study reveals that Deramiocel maintains stable left ventricular ejection fraction (LVEF) over five years, contrasting with a modeled decline of about 3.2% per year in a propensity-matched external cardiac comparator, suggesting its effectiveness in cardiac protection, which may attract more investor interest.
- Favorable Safety Profile: The five-year HOPE-2 OLE study reports no new safety signals for Deramiocel, demonstrating a favorable safety profile that could enhance confidence among physicians and patients, thereby driving market acceptance of the product.
See More
Restaurant Brands International Options Volume Surges
- Surge in Options Volume: Restaurant Brands International (QSR) has seen an options volume of 27,631 contracts today, equating to approximately 2.8 million shares, which represents a significant 76.2% of its average daily trading volume over the past month.
- High-Frequency Contracts: Notably, the $75 strike call option expiring on July 17, 2026, has traded 16,523 contracts today, representing about 1.7 million shares, indicating strong market interest at this price point.
- CAPR Options Activity: In parallel, Capricor Therapeutics (CAPR) has recorded an options volume of 7,668 contracts today, approximately 766,800 shares, which constitutes 75.2% of its average daily trading volume over the past month, highlighting investor attention on the company.
- Put Option Trading: The $20 strike put option expiring on August 21, 2026, has seen a trading volume of 5,735 contracts today, representing around 573,500 shares, reflecting a cautious market sentiment regarding CAPR's future performance.
See More
Capricor's Hope-2 Study Shows Stable Efficacy Over Five Years
- Efficacy Sustained: Capricor Therapeutics' Hope-2 extension study demonstrated that Deramiocel continued to slow disease progression over five years, with patients showing less decline in upper limb function than expected, indicating the therapy's long-term effectiveness and safety.
- Stable Cardiac Function: Throughout the study, Deramiocel maintained stable cardiac function, and no new safety concerns were reported after over 800 intravenous infusions, showcasing a favorable safety profile.
- FDA Review Progress: Capricor confirmed that its Biologics License Application (BLA) remains on track for the Prescription Drug User Fee Act (PDUFA) target action date of August 22, 2026, reflecting the company's confidence in market access.
- Market Sentiment Shift: Despite CAPR stock dropping 11% at the time of writing, retail sentiment on Stocktwits shifted from 'bullish' to 'extremely bullish', indicating heightened investor interest in the upcoming FDA advisory committee meeting.
See More
Capricor's Deramiocel BLA Under FDA Review for Duchenne Muscular Dystrophy
- FDA Advisory Meeting Scheduled: The U.S. FDA's Cellular, Tissue, and Gene Therapies Advisory Committee will meet on July 29, 2026, to discuss Capricor Therapeutics' Biologics License Application (BLA) for Deramiocel aimed at treating Duchenne muscular dystrophy (DMD).
- Clinical Trial Support: The BLA is backed by data from the Phase 2 HOPE-2 trial, long-term follow-up from the HOPE-2 open-label extension study, and positive outcomes from the Phase 3 HOPE-3 trial, which achieved its primary endpoint of Performance of Upper Limb (PUL) and key secondary endpoint of left ventricular ejection fraction (LVEF).
- Drug Designations: Deramiocel (CAP-1002) has received Orphan Drug Designation from both the FDA and EMA, along with Regenerative Medicine Advanced Therapy (RMAT) designation in the U.S., indicating its potential in DMD treatment and eligibility for a Priority Review Voucher upon approval.
- Market Reaction: Despite the positive progress of Deramiocel's application, Capricor's stock has declined by 12.11% to $26.72, reflecting market caution regarding the drug's future success.
See More
Capricor's Biologics License Application Progress
- Advisory Committee Meeting Scheduled: The FDA plans to hold an Advisory Committee meeting on July 29, 2026, to discuss Capricor's Biologics License Application (BLA) for Deramiocel, a cell therapy aimed at treating Duchenne muscular dystrophy, marking a significant advancement in the company's efforts to address rare diseases.
- Clinical Trial Support: The BLA is backed by the long-term outcomes from the company's HOPE-2 trial and HOPE-2-OLE trial, while the HOPE-3 trial achieved statistical significance on its primary endpoint (PUL v2.0) and key secondary cardiac endpoint (LVEF), demonstrating the efficacy of Deramiocel.
- Significant Therapeutic Potential: As a first-in-class therapy, Deramiocel has shown clinically meaningful and statistically significant benefits in skeletal and cardiac functions across multiple studies, with a consistent safety profile, indicating its substantial potential in treating Duchenne muscular dystrophy.
- Regulatory Support and Market Outlook: Deramiocel has received Orphan Drug Designation from both the FDA and EMA, along with Regenerative Medicine Advanced Therapy (RMAT) designation in the U.S., highlighting its competitive edge and future approval potential, which may qualify Capricor for a Priority Review Voucher.
See More
