Capricor advances amid mixed HOPE-3 data and FDA review
Capricor Therapeutics posted Q2 2026 results with no revenue, cash about $237.9 million, and a net loss of roughly $40.7 million; HOPE-3 data published in The Lancet showed a statistically significant slowing of upper limb disease progression, while an FDA advisory committee split (3 in favor, 9 against) on Deramiocel’s effectiveness for DMD cardiomyopathy left regulatory questions. The company’s BLA remains under FDA review, manufacturing readiness is advancing, and ongoing NS Pharma dispute and a Form 483 from an FDA inspection are being addressed. Capricor projects a cash runway of at least 12 months and will provide updates as regulatory clarity emerges, with regulatory engagement in Europe/Japan and a focus on expanding to younger DMD patients and Becker muscular dystrophy; other programs are on hold pending clarity.
