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-fda-leqembi-iqlik-starting-dose-pdufa-aug2026@catalyst-calendar.local
DTSTAMP:20260720T200641Z
DTSTART:20260824T130000Z
DTEND:20260824T133000Z
SUMMARY:Leqembi IQLIK皮下注射起始治疗FDA PDUFA延期后决定窗口
DESCRIPTION:Eisai/Biogen的Leqembi IQLIK每周皮下注射作为早期阿尔茨海默病起始治疗的sBLA被FDA延长审评，新PDUFA目标日期为2026年8月24日。\\nImpact score: 70\\nExpected: 若获批，皮下起始治疗可能降低早期阿尔茨海默病治疗启动门槛，影响抗淀粉样蛋白疗法商业化曲线。\\nAffected: 4523.T(subject\, unknown\, score 78)\; BIIB(licensee\, unknown\, score 73)\; BIOA-B.ST(licensor\, unknown\, score 62)\; LLY(peer\, mixed\, score 48)\; IBB(etf\, mixed\, score 40)\\nSources: BioArctic PDUFA date update: https://www.bioarctic.com/en/leqembi-iqlik-pdufa-date-updated-to-august-24-in-the-u-s/\\nEisai Leqembi IQLIK sBLA acceptance: https://www.eisai.com/news/2026/news202605.html\\nInformation only. Not investment advice.
URL:https://0.0.0.0:3000/?event=evt-fda-leqembi-iqlik-starting-dose-pdufa-aug2026
CATEGORIES:fda\,JP\,FDA\,PDUFA\,Alzheimer\,biologic
SEQUENCE:0
BEGIN:VALARM
TRIGGER:-P1D
ACTION:DISPLAY
DESCRIPTION:Review catalyst preview: Leqembi IQLIK皮下注射起始治疗FDA PDUFA延期后决定窗口
END:VALARM
BEGIN:VALARM
TRIGGER:PT24H
ACTION:DISPLAY
DESCRIPTION:Complete post-event review: Leqembi IQLIK皮下注射起始治疗FDA PDUFA延期后决定窗口
END:VALARM
END:VEVENT
END:VCALENDAR