Registro de fuente primaria
El Cellular, Tissue and Gene Therapies Advisory Committee votó 3-9 que la evidencia disponible no respalda la eficacia de Deramiocel para la miocardiopatía por DMD. La votación no es vinculante y abordó una indicación más estrecha que la propuesta; la fecha objetivo de acción PDUFA sigue siendo el 22 de agosto de 2026.
EX-99 2 capr-20260729xex99.htm EX-99 Exhibit 99.1 Capricor Therapeutics Provides Update on FDA Advisory Committee Meeting for Deramiocel SAN DIEGO , July 30, 2026 (GLOBE NEWSWIRE) — Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for rare diseases, today announced that the U.S. Food and Drug Administration's Cellular, Tissue and Gene Therapies Advisory Committee voted that available evidence did not support the effectiveness of Deramiocel for the treatment of cardiomyopathy in patients with Duchenne muscular dystrophy (DMD), a rare and life-threatening disease for which there is no approved treatment for this cardiac complication (3 for, 9 against, 0 abstain). The Committee's vote is non-binding. The Committee's v
Capricor presentará datos de 5 años del HOPE-2 OLE y del HOPE-3 Ph3 en PPMD 2026