Catalyst Event
Gilead Sciences Inc (GILD) · Other
From Akros U.S. Tech 100 Index (AUT100)
4/29/2026, 12:00:00 AM
The U.S. FDA accepted Gilead's New Drug Application (NDA) for its once-daily single-tablet HIV treatment combination, bictegravir/lenacapavir, and granted it priority review with a PDUFA action date set for August 27, 2026, which is scheduled. High importance is estimated as this is a key pipeline milestone.
Korean Translation
미국 FDA가 길리어드의 1일 1회 단일정 HIV 치료제 복합제인 빅테그라비르/레나카파비르에 대한 신약 허가 신청(NDA)을 접수하고, 우선 심사 대상으로 지정함. PDUFA 결정일은 2026년 8월 27일로 예정됨. 주요 파이프라인 마일스톤으로서 중요도를 'High'로 예상함.
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