1차 출처 기록
중대신청 제출
Prime Medicine, CGD 대상 PM359에 대해 FDA와의 협의 후 BLA 제출 계획
회사는 FDA와의 최종 협의를 진행 중이며, 협의 완료 후 PM359에 대한 BLA를 제출할 계획이라고 밝혔습니다. 최근 상호작용을 통해 기존 1/2상 데이터가 가속 승인 경로를 뒷받침할 수 있음을 시사했습니다.
핵심 사실
출처 발췌
EX-99.1 2 fy20258-kex991xpressrelease.htm EX-99.1 Document Exhibit 99.1 Prime Medicine Reports Full Year 2025 Financial Results and Provides Business Updates -- On track to file IND and/or CTA for Wilson Disease and AATD programs in 1H 2026 and mid-2026, respectively; initial clinical data for both expected in 2027 -- -- Ongoing engagement with FDA for PM359 in CGD; plan to submit BLA following final alignment -- -- Prime Medicine reported cash, cash equivalents, investments, and restricted cash of $191M providing cash runway into 2027 -- Cambridge, Mass., March 3, 2026 – Prime Medicine, Inc. (Nasdaq: PRME), a biotechnology company committed to delivering a new class of differentiated one-time curative genetic therapies, today reported financial results for the full year ended December 3