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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-replimune-rp1-melanoma-pdufa-aug2026@catalyst-calendar.local
DTSTAMP:20260720T200612Z
DTSTART:20260802T120000Z
DTEND:20260802T123000Z
SUMMARY:Replimune RP1晚期黑色素瘤BLA再提交FDA决定窗口
DESCRIPTION:RP1联合nivolumab治疗晚期黑色素瘤的BLA再提交进入FDA审评，外部日历和公司披露显示2026年8月2日前后为关键决定窗口；此前CRL使该事件具备较高二元风险。\\nImpact score: 74\\nExpected: 批准、再次CRL或限制性标签将影响溶瘤病毒免疫治疗平台与黑色素瘤后线治疗格局。\\nAffected: REPL(subject\, unknown\, score 92)\; XBI(etf\, mixed\, score 58)\; BMY(licensor\, mixed\, score 48)\; MRK(peer\, mixed\, score 46)\\nSources: Replimune FDA acceptance release: https://ir.replimune.com/news-releases/news-release-details/replimune-announces-fda-acceptance-rp1-biologics-license\\nReplimune planned BLA resubmission: https://ir.replimune.com/news-releases/news-release-details/replimune-announces-planned-rp1-bla-resubmission-following\\nReplimune CRL history: https://ir.replimune.com/news-releases/news-release-details/replimune-receives-complete-response-letter-fda-rp1-biologics-0\\nFDA CRL disclosure: https://download.open.fda.gov/crl/CRL_BLA125827_20260410.pdf\\nInformation only. Not investment advice.
URL:https://0.0.0.0:3000/?event=evt-replimune-rp1-melanoma-pdufa-aug2026
CATEGORIES:fda\,US\,FDA\,PDUFA\,melanoma\,oncolytic virus\,immunotherapy\,oncolytic immunotherapy
SEQUENCE:0
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TRIGGER:-P1D
ACTION:DISPLAY
DESCRIPTION:Review catalyst preview: Replimune RP1晚期黑色素瘤BLA再提交FDA决定窗口
END:VALARM
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TRIGGER:PT24H
ACTION:DISPLAY
DESCRIPTION:Complete post-event review: Replimune RP1晚期黑色素瘤BLA再提交FDA决定窗口
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