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 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 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 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
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 Top Line Data for Deramiocel in Duchenne Muscular Dystrophy Transcript
Capricor Therapeutics stock soars after meeting key goals with statistical significance in a phase III study of deramiocel for Duchenne cardiomyopathy.
Capricor Therapeutics Inc (NASDAQ:CAPR) is one of the best stocks on Wall Street today, up 263% to trade at $23.09, after the biotech company's cell therapy for a heart condition related to Duchenne's muscular dystrophy met the main goal of a late-stage study.