一次情報の記録
重要申請提出
Prime Medicine、CGD向けPM359のBLA申請に向けた規制当局との対話を継続
同社は、CGDに対するPM359の肯定的なPhase 1/2概念実証データを受けて、FDAとの規制当局との対話を継続していると報告しています。Prime Editing治療薬として初の規制当局への提出となるPM359のBLA申請に向け、進展しています。
主要事実
出典の抜粋
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