Capricor Therapeutics Stock Earnings Reports

Capricor reported that its BLA for deramiocel (for Duchenne muscular dystrophy) is under active FDA review with a PDUFA target action date of August 22, 2026. The company submitted a Class 2 resubmission after the July 2025 CRL supported by HOPE-3 Phase 3 data showing statistical and clinical benefit on primary (PUL v2.0) and key cardiac secondary endpoints (LVEF and cardiac MRI fibrosis stabilization). Safety data include >800 IV infusions and up to 5 years of OLE exposure in some patients. Capricor expects potential eligibility for a priority review voucher if approved. The company has initiated commercial readiness activities, scaling in-house GMP manufacturing (current capacity ~200–250 patients/year from existing facility; planned expansion to support ~2,000–2,500 patients/year with full validation targeted in 2027) and hiring key commercial and market access leadership. Capricor also filed suit (May 7, 2026) seeking rescission of its U.S. distribution agreement with NS Pharma/Nippon Shinyaku and a preliminary injunction to enable Capricor to distribute deramiocel pending approval; management cites an unfixable pricing/ transfer-price structure in the distribution agreement that would block access for Medicare/Medicaid/private-pay patients. Financially, the company had ~$279M in cash, equivalents and marketable securities as of March 31, 2026, which management believes funds operations into 2027 (excluding potential product revenue or PRV proceeds). Capricor continues R&D on exosome programs and plans lifecycle/indication expansions (including Becker muscular dystrophy) and international regulatory interactions (EMA, PMDA). Management emphasizes commitment to launching and getting deramiocel to eligible patients rapidly if approved, while the litigation proceeds.