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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-vrbpac-mflusiva-mrna-flu-june-2026@catalyst-calendar.local
DTSTAMP:20260720T200642Z
DTSTART:20260805T130000Z
DTEND:20260805T133000Z
SUMMARY:Moderna mRNA-1010流感疫苗FDA PDUFA决定窗口
DESCRIPTION:FDA已受理Moderna mRNA-1010季节性流感疫苗BLA修订申请，PDUFA目标日期为2026年8月5日；FDA疫苗咨询委员会此前已讨论MFLUSIVA用于50岁及以上人群。\\nImpact score: 76\\nExpected: FDA决定将影响mRNA呼吸道疫苗平台商业化、监管标准和2026/2027流感季供应预期。\\nAffected: MRNA(subject\, mixed\, score 90)\; BNTX(peer\, mixed\, score 62)\; PFE(peer\, mixed\, score 58)\; GSK(peer\, mixed\, score 57)\; SNY(peer\, mixed\, score 57)\; XBI(etf\, mixed\, score 56)\\nSources: FDA VRBPAC June 18 2026 meeting announcement: https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-june-18-2026-meeting-announcement\\nFDA VRBPAC 2026 meeting materials: https://www.fda.gov/advisory-committees/vaccines-and-related-biological-products-advisory-committee/2026-meeting-materials-vaccines-and-related-biological-products-advisory-committee\\nFDA advisory committee calendar: https://www.fda.gov/advisory-committees/advisory-committee-calendar\\nFDA advisory committees upcoming meetings: https://www.fda.gov/advisory-committees\\nFederal Register public inspection: https://www.federalregister.gov/public-inspection/2026-10321/hearings-meetings-proceedings-etc-vaccines-and-related-biological-products-advisory-committee-safety\\nFDA briefing document PDF: https://www.fda.gov/media/193130/download\\nModerna SEC exhibit on mRNA-1010 FDA correspondence: https://www.sec.gov/Archives/edgar/data/1682852/000168285226000012/exhibit991-02102026.htm\\nModerna review acceptance report: https://www.biospace.com/press-releases/moderna-announces-the-u-s-food-and-drug-administration-will-initiate-the-review-of-its-investigational-seasonal-influenza-vaccine-submission\\nFDA agenda PDF: https://www.fda.gov/media/193133/download\\nModerna investor relations: https://investors.modernatx.com/\\nBioPharma International advisory panel update: https://www.biopharminternational.com/view/fda-advisory-panel-votes-9-0-in-favor-of-moderna-s-mrna-flu-vaccine-setting-stage-for-august-decision\\nModerna press release feed: https://feeds.issuerdirect.com/news-release.html?newsid=8923338804483797&symbol=MRNA\\nFDA novel drug approvals page: https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2026\\nModerna trial page mRNA-1010 P304: https://trials.modernatx.com/study/?id=mRNA-1010-P304\\nModerna amended BLA release mirror: https://www.accessnewswire.com/newsroom/en/healthcare-and-pharmaceutical/moderna-announces-the-u.s.-food-and-drug-administration-will-initiate-1138398\\nPharmExec FDA review note: https://www.pharmexec.com/view/fda-initiating-review-moderna-seasonal-flu-vaccine-revised-regulatory-approach\\nWall Street Journal VRBPAC vote report: https://www.wsj.com/health/pharma/fda-votes-in-favor-of-benefit-risk-profile-for-modernas-flu-vaccine-11821d88\\nModerna Japanese official release: https://www.modernatx.com/ja-JP/press-release/2026/20260220\\nModerna RTF context PR feed: https://feeds.issuerdirect.com/news-release.html?newsid=7346090610333866&symbol=MRNA\\nInformation only. Not investment advice.
URL:https://0.0.0.0:3000/?event=evt-fda-vrbpac-mflusiva-mrna-flu-june-2026
CATEGORIES:fda\,US\,FDA\,VRBPAC\,mRNA vaccine\,influenza\,mRNA\,influenza vaccine\,vaccine\,PDUFA\,flu vaccine\,mRNA疫苗\,流感疫苗
SEQUENCE:0
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TRIGGER:-P1D
ACTION:DISPLAY
DESCRIPTION:Review catalyst preview: Moderna mRNA-1010流感疫苗FDA PDUFA决定窗口
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TRIGGER:PT24H
ACTION:DISPLAY
DESCRIPTION:Complete post-event review: Moderna mRNA-1010流感疫苗FDA PDUFA决定窗口
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