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-leqembi-iqlik-subcutaneous-pdufa-aug2026@catalyst-calendar.local
DTSTAMP:20260720T200611Z
DTSTART:20260824T120000Z
DTEND:20260824T123000Z
SUMMARY:Eisai/Biogen Leqembi Iqlik阿尔茨海默病皮下注射起始剂量PDUFA窗口
DESCRIPTION:FDA将Leqembi Iqlik作为早期阿尔茨海默病起始剂量的sBLA审评延长至2026年8月24日，以审查补充资料；事件影响抗淀粉样蛋白疗法给药便利性和渗透率预期。\\nImpact score: 67\\nExpected: 决定将影响Leqembi从输注中心向居家皮下给药扩展的商业化斜率。\\nAffected: BIIB(subject\, mixed\, score 78)\; ESALY(subject\, mixed\, score 78)\; 4523.T(subject\, mixed\, score 76)\; LLY(peer\, mixed\, score 58)\; IBB(etf\, mixed\, score 44)\\nSources: Biogen Leqembi IQLIK update: https://investors.biogen.com/news-releases/news-release-details/update-fda-priority-review-leqembir-iqliktm-lecanemab-irmb\\nBioArctic Leqembi PDUFA update: https://www.bioarctic.com/en/leqembi-iqlik-pdufa-date-updated-to-august-24-in-the-u-s/\\nEisai prior sBLA acceptance: https://www.eisai.com/news/2026/news202608.html\\nBioArctic Leqembi IQLIK update: https://www.prnewswire.com/news-releases/leqembi-iqlik-pdufa-date-updated-to-august-24-in-the-us-302766719.html\\nEisai Leqembi Iqlik PDUFA update: https://www.eisai.com/news/2026/news202625.html\\nEisai original sBLA acceptance: https://www.eisai.com/news/2026/news202605.html\\nBiogen/Eisai PRNewswire acceptance release: https://www.prnewswire.com/news-releases/fda-accepts-leqembi-iqliktm-lecanemab-irmb-supplemental-biologics-license-application-as-a-subcutaneous-starting-dose-for-the-treatment-of-early-alzheimers-disease-under-priority-review-302669609.html\\nInformation only. Not investment advice.
URL:https://0.0.0.0:3000/?event=evt-leqembi-iqlik-subcutaneous-pdufa-aug2026
CATEGORIES:fda\,US\,FDA\,PDUFA\,阿尔茨海默病\,Leqembi\,皮下注射\,Alzheimer\,anti-amyloid\,subcutaneous\,subcutaneous biologic
SEQUENCE:0
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TRIGGER:-P1D
ACTION:DISPLAY
DESCRIPTION:Review catalyst preview: Eisai/Biogen Leqembi Iqlik阿尔茨海默病皮下注射起始剂量PDUFA窗口
END:VALARM
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TRIGGER:PT24H
ACTION:DISPLAY
DESCRIPTION:Complete post-event review: Eisai/Biogen Leqembi Iqlik阿尔茨海默病皮下注射起始剂量PDUFA窗口
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