Capricor Therapeutics Inc
F:4LN2
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Capricor Therapeutics Inc
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Capricor Therapeutics Inc
Capricor Therapeutics is a biotechnology company that develops cell-based medicines for serious diseases, with a main focus on heart and muscle disorders. Its lead program is deramiocel, an allogeneic cardiosphere-derived cell therapy being studied for Duchenne muscular dystrophy, a genetic disease that weakens muscles over time. The company also works on exosome-based therapies, which use tiny particles released by cells as a way to deliver treatment signals. The company does not sell a broad range of drugs. It earns money mainly through research and development funding, collaboration payments, and, if its programs succeed, potential future product sales or licensing deals. Its main customers are not typical consumers; they are regulators, research partners, doctors, hospitals, and eventually patients and payers if a therapy reaches the market. What makes Capricor different is that it sits very early in the drug-development chain and focuses on hard-to-treat rare diseases where standard medicines often do not help enough. Instead of making mass-market pills, it is building specialized biologic treatments that must be tested, approved, and then delivered through clinical and medical channels.
Capricor Therapeutics is a biotechnology company that develops cell-based medicines for serious diseases, with a main focus on heart and muscle disorders. Its lead program is deramiocel, an allogeneic cardiosphere-derived cell therapy being studied for Duchenne muscular dystrophy, a genetic disease that weakens muscles over time. The company also works on exosome-based therapies, which use tiny particles released by cells as a way to deliver treatment signals.
The company does not sell a broad range of drugs. It earns money mainly through research and development funding, collaboration payments, and, if its programs succeed, potential future product sales or licensing deals. Its main customers are not typical consumers; they are regulators, research partners, doctors, hospitals, and eventually patients and payers if a therapy reaches the market.
What makes Capricor different is that it sits very early in the drug-development chain and focuses on hard-to-treat rare diseases where standard medicines often do not help enough. Instead of making mass-market pills, it is building specialized biologic treatments that must be tested, approved, and then delivered through clinical and medical channels.
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).
