Capricor Therapeutics Reports Q3 Loss; Deramiocel BLA PDUFA Nov 22
Capricor Therapeutics announced its third quarter 2026 financial results, reporting a net loss of $42.7 million, or $0.73 per share, compared to a net loss of $24.6 million, or $0.54 per share, in the third quarter of 2025. Operating expenses increased significantly due to pre-commercial activities and manufacturing scale-up, leading to a workforce reduction of approximately 10%. The company's cash position decreased to $198.5 million. Key corporate updates include the ongoing FDA review of the Deramiocel BLA for Duchenne muscular dystrophy, with a PDUFA date set for November 22, 2026. Positive clinical data from the HOPE-3 trial, including a 76% slowing in upper limb decline and an award for cardiac results, were highlighted.
Key Highlights
- Capricor Therapeutics reported Q3 2026 net loss of $42.7 million ($0.73/share), compared to $24.6 million ($0.54/share) in Q3 2025.
- Total operating expenses for Q3 2026 were $44.7 million, up from $26.3 million in Q3 2025, driven by pre-commercial activities and manufacturing scale-up.
- Cash, cash equivalents, restricted cash and marketable securities totaled $198.5 million as of September 30, 2026, down from $318.1 million as of December 31, 2025.
- Deramiocel BLA for Duchenne muscular dystrophy under FDA review with PDUFA target action date of November 22, 2026.
- Two-year HOPE-3 OLE data showed 76% slower upper limb decline in patients switched from placebo to Deramiocel.
- HOPE-3 cardiac results received the American Heart Association Outstanding Research Award in Pediatric Cardiology.
- Company implemented a workforce reduction affecting approximately 10% of its employees in Q3 2026.
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