Cabaletta Bio 計劃於 2027 年提交 rese-cel 用於肌炎的 BLA

該公司宣布與 FDA 達成一致，在 RESET-Myositis 試驗中針對皮肌炎/抗合成酶症候群進行 14 名患者的單臂註冊隊列。所有符合關鍵標準的 Phase 1/2 患者均達到 16 週主要終點。註冊隊列的招募預計將在本季度開始，支持計劃於 2027 年提交 BLA。

關鍵事實

申報時間: 2025年11月10日下午12:33
事件: 申請已送件
方向: 正面
公司: CABACabaletta Bio
資產: rese-cel
來源: SEC 8-K
可信度: 有出處
主要終點: 16 週中度或重度總改善分數反應
註冊性試驗群組規模: 14 名患者

來源摘錄

EX-99.1 2 caba-ex99_1.htm EX-99.1 EX-99.1 Exhibit 99.1 Cabaletta Bio Reports Third Quarter 2025 Financial Results and Provides Business Update Rese-cel data presented at multiple medical meetings demonstrated potentially transformative, drug-free clinical responses with a favorable safety profile for autoimmune patients supporting outpatient use All myositis patients in the Phase 1/2 DM/ASyS cohort with sufficient follow-up who would have met key criteria for the registrational cohort met the registrational, 16-week primary endpoint Planned BLA submission for rese-cel in 2027 based on 14-patient, single-arm DM/ASyS registrational cohort initiating enrollment this quarter within the RESET-Myositis™ trial FDA alignment on additional registrational cohort designs for RESET-SSc™ and RES

SEC 8-K