Catalyst Event
Cogent Biosciences Inc (COGT) · Other
From KEDI U.S. Next Tech TOP10 Index (KUNTT10)
3/16/2026, 12:00:00 AM
The U.S. FDA accepted the New Drug Application (NDA) for bezuclastinib for patients with Non-Advanced Systemic Mastocytosis (NonAdvSM), assigning a PDUFA target action date of December 30, 2026, expected. High impact (>10%) estimated due to major regulatory milestone.
Korean Translation
미국 FDA, 비진행성 전신성 비만세포증(NonAdvSM) 환자 치료를 위한 베주클라스티닙의 신약 허가 신청(NDA)을 접수하고, 처방약 사용자 수수료법(PDUFA)에 따른 목표 조치일을 2026년 12월 30일로 지정함이 예상됨. 주요 규제 이정표 달성에 따라 10% 이상의 높은 시장 영향이 예상됨.
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