BEGIN:VCALENDAR
VERSION:2.0
PRODID:-//Catalyst Calendar//CN-US Event Research//ZH
CALSCALE:GREGORIAN
METHOD:PUBLISH
X-WR-CALNAME:Catalyst Calendar
X-WR-CALDESC:Market-moving event research, reminders and post-event review.
BEGIN:VEVENT
UID:evt-gilead-bic-len-hiv-pdufa-aug2026@catalyst-calendar.local
DTSTAMP:20260720T200547Z
DTSTART:20260827T120000Z
DTEND:20260827T123000Z
SUMMARY:Gilead BIC/LEN每日单片HIV治疗NDA优先审评PDUFA窗口
DESCRIPTION:FDA已受理Gilead bictegravir/lenacapavir每日单片组合用于病毒学抑制成人HIV患者的NDA并授予优先审评，PDUFA日期为2026年8月27日；该事件可能影响HIV治疗从多药方案向简化高耐药屏障方案迁移的预期。\\nImpact score: 69\\nExpected: FDA决定是否批准BIC/LEN单片方案；市场关注其对Biktarvy生命周期、复杂多片方案替换和lenacapavir平台化的影响。\\nAffected: GILD(subject\, unknown\, score 78)\; GSK(peer\, mixed\, score 52)\; MRK(peer\, mixed\, score 46)\; IBB(etf\, mixed\, score 38)\\nSources: Gilead BIC/LEN NDA acceptance PR: https://www.gilead.com/news/news-details/2026/u-s--fda-grants-priority-review-of-new-drug-application-for-gileads-once-daily-hiv-treatment-of-bictegravir-plus-lenacapavir\\nGilead Q1 2026 results: https://www.gilead.com/news/news-details/2026/gilead-sciences-announces-first-quarter-financial-results\\nInformation only. Not investment advice.
URL:https://0.0.0.0:3000/?event=evt-gilead-bic-len-hiv-pdufa-aug2026
CATEGORIES:fda\,US\,FDA\,PDUFA\,HIV\,lenacapavir\,single-tablet regimen\,bictegravir
SEQUENCE:0
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TRIGGER:-P1D
ACTION:DISPLAY
DESCRIPTION:Review catalyst preview: Gilead BIC/LEN每日单片HIV治疗NDA优先审评PDUFA窗口
END:VALARM
BEGIN:VALARM
TRIGGER:PT24H
ACTION:DISPLAY
DESCRIPTION:Complete post-event review: Gilead BIC/LEN每日单片HIV治疗NDA优先审评PDUFA窗口
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