Capricor (CAPR) Plans February FDA Data Submission After 2% Stock Drop
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jan 20 2026
0mins
Should l Buy CAPR?
Source: stocktwits
- 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.
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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: 30.120
Low
45.00
Averages
51.57
High
60.00
Current: 30.120
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.
Analysts Bullish on Capricor's Treatment Prospects
- FDA Review Resumed: The U.S. FDA has lifted the previously issued Complete Response Letter and resumed the review of the Biologics License Application for Deramiocel, with a decision expected by August 22, 2026, bringing renewed hope for Capricor's treatment prospects.
- Analyst Price Target Increases: B. Riley raised Capricor's price target from $50 to $63 while maintaining a ‘Buy’ rating, reflecting increased confidence in a smooth approval path for Deramiocel ahead of the decision date, with shares expected to rise.
- Positive Market Reaction: Despite Capricor reporting a wider-than-expected loss in its latest earnings call, leading to a 9% drop in shares, Roth Capital analysts view this pullback as a transient market correction and recommend buying, with a target price of $41.
- Strong Cash Position: Piper Sandler increased Capricor's price target from $45 to $58, noting the company ended 2025 with $318 million in cash to fund operations through 2027, indicating a solid financial foundation for future growth.
See More
CAPRICOR THERAPEUTICS INC: B. RILEY INCREASES TARGET PRICE FROM $50 TO $63
- Price Increase Announcement: Capricor Therapeutics has raised its target price from $50 to $63.
- Analyst Involvement: The price adjustment was made by analyst B. Riley, indicating a positive outlook for the company's stock.
See More
CAPR Stock Poised for Strongest Weekly Performance in Almost a Month: CEO Asserts 'No Chance' of Deramiocel Receiving Just Conditional Approval
CEO's Stance on Regulatory Approval: Linda Marban, CEO of Capricor Therapeutics, dismissed concerns regarding the conditional FDA approval for their therapy, Deramciclus, emphasizing that the trial met both primary and key secondary endpoints.
Financial Performance: Capricor reported a wider-than-expected Q4 loss of $0.62 per share with no revenue, but ended 2025 with approximately $318.1 million in cash, which will support operations into late 2027.
Launch Preparations: The company is preparing for a potential commercial launch of Deramciclus, having completed FDA pre-license inspections and planning to stockpile doses once labeling discussions are finalized.
Positive Clinical Data: Recent Phase 3 trial results showed significant improvements in upper limb function and cardiac health for patients with Duchenne muscular dystrophy, leading to increased physician interest and inquiries about the therapy.
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
Analysts Bullish on Capricor's Treatment Prospects
- FDA Review Resumed: The U.S. FDA has lifted the previously issued Complete Response Letter and resumed the review of the Biologics License Application for Deramiocel, with a decision expected by August 22, 2026, bringing renewed hope for Capricor's treatment prospects.
- Analyst Price Target Increases: B. Riley raised Capricor's price target from $50 to $63 while maintaining a ‘Buy’ rating, reflecting increased confidence in a smooth approval path for Deramiocel ahead of the decision date, with shares expected to rise.
- Positive Market Reaction: Despite Capricor reporting a wider-than-expected loss in its latest earnings call, leading to a 9% drop in shares, Roth Capital analysts view this pullback as a transient market correction and recommend buying, with a target price of $41.
- Strong Cash Position: Piper Sandler increased Capricor's price target from $45 to $58, noting the company ended 2025 with $318 million in cash to fund operations through 2027, indicating a solid financial foundation for future growth.
See More
CAPRICOR THERAPEUTICS INC: B. RILEY INCREASES TARGET PRICE FROM $50 TO $63
- Price Increase Announcement: Capricor Therapeutics has raised its target price from $50 to $63.
- Analyst Involvement: The price adjustment was made by analyst B. Riley, indicating a positive outlook for the company's stock.
See More
CAPR Stock Poised for Strongest Weekly Performance in Almost a Month: CEO Asserts 'No Chance' of Deramiocel Receiving Just Conditional Approval
CEO's Stance on Regulatory Approval: Linda Marban, CEO of Capricor Therapeutics, dismissed concerns regarding the conditional FDA approval for their therapy, Deramciclus, emphasizing that the trial met both primary and key secondary endpoints.
Financial Performance: Capricor reported a wider-than-expected Q4 loss of $0.62 per share with no revenue, but ended 2025 with approximately $318.1 million in cash, which will support operations into late 2027.
Launch Preparations: The company is preparing for a potential commercial launch of Deramciclus, having completed FDA pre-license inspections and planning to stockpile doses once labeling discussions are finalized.
Positive Clinical Data: Recent Phase 3 trial results showed significant improvements in upper limb function and cardiac health for patients with Duchenne muscular dystrophy, leading to increased physician interest and inquiries about the therapy.
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
