一次情報の記録
重要PDUFA 日設定
Gilead: FDAがBIC/LEN NDAのPDUFA日をAugust 27, 2026に設定
FDAはBIC/LENのNDAを優先審査で受理した。同機関はPDUFA目標アクション日をAugust 27, 2026に割り当て、ウイルス抑制されたHIV患者向けのこの単一錠剤レジメンの規制タイムラインを確立した。
主要事実
- 提出
- 2026年5月7日 20:03
- イベント
- PDUFA 日設定
- 方向
- 中立
- 出典
- SEC 8-K
- 信頼度
- 出典あり
- カレンダー
- FDA 審査決定 (PDUFA) · 2026年8月27日 · 結果未記録
出典の抜粋
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