Capricor Therapeutics Inc
NASDAQ:CAPR
Capricor Therapeutics Inc
Capricor Therapeutics, Inc. engages in the discovery, development and commercialization of first-in-class biological therapies for the treatment of cardiac and other serious medical conditions. The company is headquartered in Beverly Hills, California and currently employs 48 full-time employees. The company went IPO on 2002-06-04. The firm consists of cell therapy program, including CAP-1002 for Duchenne Muscular Dystrophy program and CAP-1002 with CAP-1002 for coronavirus (COVID-19). The Company’s lead candidate, CAP-1002, is an allogeneic cardiac-derived cell therapy. CAP-1002 is in clinical development for treating Duchenne muscular dystrophy and the cytokine storm associated with COVID-19. Capricor is also developing its exosome technology therapeutic platform. The firm is focused on developing exosomes capable of delivering nucleic acids, including messenger RNA (mRNA) as well as proteins, to treat or prevent a range of diseases. CAP-1002 cell therapy programs initiated Pivotal Phase III, HOPE-3.
Capricor Therapeutics, Inc. engages in the discovery, development and commercialization of first-in-class biological therapies for the treatment of cardiac and other serious medical conditions. The company is headquartered in Beverly Hills, California and currently employs 48 full-time employees. The company went IPO on 2002-06-04. The firm consists of cell therapy program, including CAP-1002 for Duchenne Muscular Dystrophy program and CAP-1002 with CAP-1002 for coronavirus (COVID-19). The Company’s lead candidate, CAP-1002, is an allogeneic cardiac-derived cell therapy. CAP-1002 is in clinical development for treating Duchenne muscular dystrophy and the cytokine storm associated with COVID-19. Capricor is also developing its exosome technology therapeutic platform. The firm is focused on developing exosomes capable of delivering nucleic acids, including messenger RNA (mRNA) as well as proteins, to treat or prevent a range of diseases. CAP-1002 cell therapy programs initiated Pivotal Phase III, HOPE-3.
PDUFA date: FDA accepted Capricor's BLA for Deramiocel and set a PDUFA target action date of August 22, 2026.
Clinical data: HOPE-3 (n=106) met its primary endpoint (performance of the upper limb) and Type 1 error–controlled secondaries; LV ejection fraction showed a 91% slowing of disease progression overall and stronger effect in patients with cardiomyopathy (p=0.01).
Safety: Deramiocel has a consistent safety profile across >800 intravenous infusions and >100 patients in open‑label extension (some receiving continuous infusions up to 5 years).
Manufacturing capacity: Current San Diego facility can support ~250 patients/year (with stockpiling plan); planned expansion to add ~6 clean rooms to support ~2,500 patients/year (~10,000 doses) with that expansion expected online in late 2027.
Commercial readiness & strategy: Company is building a commercial organization (market access, reimbursement, patient support) and plans to transition open‑label patients to commercial supply; aiming to prepare for broad label consistent with data (skeletal and cardiac benefit).
Balance sheet: Cash, cash equivalents and marketable securities were approximately $318.1 million as of December 31, 2025 (cash believed sufficient to fund operations into Q4 2027; does not assume PRV sale or product revenue).
