Capricor Therapeutics Inc. (CAPR)
Capricor Therapeutics shares tumble after FDA reviewers raise concerns over Duchenne therapy
Capricor Therapeutics (NASDAQ:CAPR) shares fell about 67% on Monday after US Food and Drug Administration (FDA) staff reviewers raised concerns about the evidence supporting the effectiveness of the company's experimental cell therapy, deramiocel, for Duchenne muscular dystrophy (DMD)-associated cardiomyopathy. The FDA released briefing documents ahead of a July 29 meeting of its Cellular, Tissue, and Gene Therapies Advisory Committee, which will review the therapy's efficacy and overall risk-benefit profile before the agency's August 22 Prescription Drug User Fee Act (PDUFA) target action date.
FDA staff flags concerns for Capricor's Duchenne heart disease therapy
U.S. Food and Drug Administration staff reviewers raised concerns about whether Capricor Therapeutics' cell therapy deramiocel has sufficient evidence of effectiveness for treating cardiomyopathy in Duchenne muscular dystrophy, according to briefing documents released on Monday.
Capricor Therapeutics Eyes FDA Approval Path for Duchenne Cell Therapy
Capricor Therapeutics NASDAQ: CAPR executives said the company is in active discussions with the U.S. Food and Drug Administration as it works toward a potential approval decision for deramiocel, its allogeneic cardiac-derived cell therapy for Duchenne muscular dystrophy.
Capricor Therapeutics, Inc. (CAPR) Presents at Goldman Sachs 47th Annual Global Healthcare Conference 2026 Transcript
Capricor Therapeutics, Inc. (CAPR) Presents at Goldman Sachs 47th Annual Global Healthcare Conference 2026 Transcript
Capricor: I Rate It A Buy After Stress-Testing The Sell Thesis
Capricor is rated a speculative Buy ahead of its August 22 PDUFA for deramiocel in Duchenne muscular dystrophy. Recent HOPE-3 data disclosures address most prior concerns about primary and cardiac endpoints, reducing trial-related risks. Key remaining risks include commercial disputes with NS Pharma/Nippon Shinyaku and limited initial manufacturing capacity.
Capricor Therapeutics, Inc. (CAPR) Q1 2026 Earnings Call Transcript
Capricor Therapeutics, Inc. (CAPR) Q1 2026 Earnings Call Transcript
Capricor Therapeutics Q1 Earnings Call Highlights
Capricor Therapeutics NASDAQ: CAPR said its Duchenne muscular dystrophy therapy candidate deramiocel remains under active FDA review, while the company is preparing to commercialize the product itself amid a legal dispute with distribution partner NS Pharma and parent company Nippon Shinyaku.
Capricor Therapeutics Stock Slides As Q4 Earnings Miss Estimates
Capricor posted a quarterly loss of 62 cents per share, missing the consensus estimate of a 54-cent loss and worsening from a 16-cent loss in the prior-year period.
Capricor Therapeutics, Inc. (CAPR) Q4 2025 Earnings Call Transcript
Capricor Therapeutics, Inc. (CAPR) Q4 2025 Earnings Call Transcript
CAPR Updates FDA on Deramiocel BLA, Plans HOPE-3 CSR Filing in February
CAPR said the FDA wants the full HOPE-3 study report for Deramiocel and confirmed no new clinical trials are needed.
Capricor Therapeutics, Inc. (CAPR) Discusses HOPE-3 Phase III Trial Results and Regulatory Path for Duchenne Muscular Dystrophy Therapy Transcript
Capricor Therapeutics, Inc. (CAPR) Discusses HOPE-3 Phase III Trial Results and Regulatory Path for Duchenne Muscular Dystrophy Therapy Transcript
Capricor Therapeutics, Inc. (CAPR) Discusses HOPE-3 Phase III Top Line Data for Deramiocel in Duchenne Muscular Dystrophy Transcript
Capricor Therapeutics, Inc. (CAPR) Discusses HOPE-3 Phase III Top Line Data for Deramiocel in Duchenne Muscular Dystrophy Transcript
