一次情報の記録
重要申請提出
Prime Medicine、FDAとの調整後にCGD向けPM359のBLA提出を計画
同社はFDAとの最終調整に向けて取り組んでおり、その調整後にPM359のBLA提出を予定していると述べています。最近のやり取りから、既存のPhase 1/2データが迅速承認経路を支持する可能性があることが示唆されています。
主要事実
出典の抜粋
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