1차 출처 기록
중대신청 제출
Prime Medicine, CGD 대상 PM359의 BLA 제출을 위한 규제 대화 지속
회사는 CGD 대상 PM359의 긍정적인 1/2상 개념 증명 데이터 이후 FDA와의 규제 대화를 지속하고 있다고 보고했습니다. Prime Editing 치료제 최초의 규제 제출이 될 PM359의 잠재적 BLA 제출을 진행 중입니다.
핵심 사실
출처 발췌
EX-99.1 2 q120268-kex991xpressrelease.htm EX-99.1 Document Exhibit 99.1 Prime Medicine Reports First Quarter 2026 Financial Results and Provides Business Updates -- On track to file IND and/or CTA for PM577 in Wilson Disease in H1 2026 and for PM647 in AATD mid-2026; initial clinical data from both programs expected in 2027 -- -- Continued regulatory dialogue with the FDA toward BLA filing for PM359 in CGD -- -- Strengthened leadership team with appointment of Svetlana Makhni as Chief Financial Officer -- -- Cash, cash equivalents, investments, and restricted cash of $149.2 million as of March 31, 2026, providing cash runway into 2027 -- Cambridge, Mass., May 7, 2026 – Prime Medicine, Inc. (Nasdaq: PRME), a biotechnology company committed to delivering a new class of differentiated one-t