
Capricor Therapeutics Q2 Net Loss $40.7M; Deramiocel BLA Under FDA Review
Capricor Therapeutics reported a net loss of $40.7 million for the second quarter of 2026, an increase from $25.9 million in the same period last year, with total operating expenses rising to $42.9 million. The company maintained a strong cash position of $237.9 million as of June 30, 2026, sufficient to fund operations for at least the next twelve months. The Biologics License Application (BLA) for Deramiocel remains under active FDA review, despite a negative Advisory Committee vote (3 in favor, 9 against) regarding its use for cardiomyopathy in Duchenne Muscular Dystrophy, though feedback on upper limb function was supportive. The full HOPE-3 Phase 3 dataset, demonstrating statistically significant slowing of upper limb disease progression, was published in The Lancet.
Key Highlights
- Net loss for Q2 2026 was $40.7 million, compared to $25.9 million for Q2 2025.
- Cash, cash equivalents, and marketable securities totaled $237.9 million as of June 30, 2026.
- Deramiocel Biologics License Application (BLA) is under active FDA review.
- FDA Advisory Committee voted 3 in favor and 9 against for cardiomyopathy indication of Deramiocel.
- HOPE-3 Phase 3 results published in The Lancet, showing significant slowing of upper limb disease progression (p=0.029).
- Total operating expenses for Q2 2026 were $42.9 million, up from $27.7 million in Q2 2025.
- Company expects current cash to fund operations for at least the next twelve months.
Price Impact
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