原始出處紀錄
重大申請已送件
Prime Medicine 計畫在與 FDA 達成一致後，為 CGD 的 PM359 提交 BLA
該公司表示正致力於與 FDA 達成最終一致，並打算在達成一致後提交 PM359 的 BLA。最近的互動顯示，現有的 1/2 期數據可能支持加速批准途徑。
關鍵事實
來源摘錄
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