1차 출처 기록
결정급자문위원회 투표
Capricor: FDA AdComm, Deramiocel의 DMD 심근병증에 대한 유효성에 반대표
Cellular, Tissue and Gene Therapies Advisory Committee는 Deramiocel의 DMD 심근병증에 대한 유효성을 뒷받침하는 증거가 없다고 3-9로 투표했습니다. 이 투표는 구속력이 없으며 제안된 것보다 좁은 적응증을 다루었습니다. PDUFA 목표 조치일은 2026년 8월 22일로 유지됩니다.
핵심 사실
출처 발췌
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