1차 출처 기록
중대PDUFA 날짜 확정
Gilead: FDA가 BIC/LEN NDA의 PDUFA 날짜를 2026년 8월 27일로 설정
FDA accepted the NDA for BIC/LEN under priority review. The agency assigned a PDUFA target action date of August 27, 2026, establishing the regulatory timeline for this single-tablet regimen in virologically suppressed HIV patients.
핵심 사실
- 제출
- 2026년 5월 7일 PM 08:03
- 이벤트
- PDUFA 날짜 확정
- 방향
- 중립
- 출처
- SEC 8-K
- 신뢰도
- 출처 확인
- 캘린더
- FDA 심사 결정 (PDUFA) · 2026년 8월 27일 · 결과 미기록
출처 발췌
EX-99.1 2 exhibit991earningspressrel.htm EXHIBIT 99.1 Document GILEAD SCIENCES ANNOUNCES FIRST QUARTER FINANCIAL RESULTS Product Sales Excluding Veklury Increased 8% Year-Over-Year to $6.8 billion Biktarvy Sales Increased 7% Year-Over-Year to $3.4 billion Foster City, CA, May 7, 2026 - Gilead Sciences, Inc. (Nasdaq: GILD) announced today its results of operations for the first quarter 2026. “Gilead teams have delivered another strong quarter with 8% year-over-year growth in our base business and 10% growth in HIV, supported by the successful launch of Yeztugo. We have raised our full year revenue guidance as a reflection of our performance," said Daniel O’Day, Gilead’s Chairman and Chief Executive Officer. “Building on the strongest pipeline in Gilead’s history, we are adding potentially