Quarterly ResultMay 12, 2026, 04:13 PM
Capricor Q1 Net Loss $33.9M; Deramiocel BLA Under FDA Review
AI Summary
Capricor Therapeutics reported a net loss of $33.9 million, or $0.59 per share, for the first quarter ended March 31, 2026, an increase from $24.4 million in the prior year. The company's Deramiocel Biologics License Application (BLA) is under active FDA review with a PDUFA target action date of August 22, 2026, following the successful HOPE-3 Phase 3 trial. Capricor also announced it has filed a lawsuit against NS Pharma to rescind its U.S. distribution agreement, citing a flawed pricing structure and failure to fulfill commercial obligations, though the FDA review remains unaffected.
Key Highlights
- Deramiocel BLA under active FDA review with PDUFA target action date of August 22, 2026.
- Q1 2026 net loss was $33.9 million, or $0.59 per share, compared to $24.4 million ($0.53 per share) in Q1 2025.
- Cash, cash equivalents, and marketable securities totaled $278.6 million as of March 31, 2026.
- Total operating expenses increased to $36.8 million in Q1 2026 from $25.0 million in Q1 2025.
- Cash balance is expected to support operations into Q4 2027.
- Company filed suit against NS Pharma seeking rescission of U.S. distribution agreement.
- HOPE-3 Phase 3 trial met its primary and all Type I error-controlled secondary endpoints.
- A Chief Commercial Officer with direct DMD commercial experience is expected to join soon.