Catalyst Event
Gilead Sciences Inc (GILD) · Other
From Akros SCHK HK-U.S. Biotech Index (ASHUBIO)
4/29/2026, 12:00:00 AM
The U.S. FDA accepted for Priority Review the New Drug Application (NDA) for the investigational once-daily single-tablet HIV treatment regimen, bictegravir/lenacapavir (BIC/LEN) on 2026-04-29. This major regulatory milestone is estimated to have a high price impact of over 10% due to the significance of the HIV franchise.
Korean Translation
2026년 4월 29일 미국 FDA가 1일 1회 단일정 HIV 치료제 후보물질 빅테그라비르/레나카파비르(BIC/LEN)의 신약허가신청(NDA)을 우선심사 대상으로 접수함. HIV 사업부의 중요성을 고려할 때 10% 이상의 높은 주가 영향이 예상됨.
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