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-replimune-rp1-melanoma-adcom-pdufa-2026@catalyst-calendar.local
DTSTAMP:20260720T200555Z
DTSTART:20260725T130000Z
DTEND:20260725T133000Z
SUMMARY:Replimune RP1晚期黑色素瘤BLA再提交审评与AdCom/PDUFA窗口
DESCRIPTION:Replimune宣布FDA接受RP1联合nivolumab用于晚期黑色素瘤的BLA再提交，按Class 1 response设定2026年8月2日目标日期，并通知公司预计7月下旬召开AdCom。该事件是肿瘤溶瘤免疫疗法和FDA加速批准灵活性的高二元监管窗口。\\nImpact score: 76\\nExpected: 关注AdCom是否召开、投票问题、FDA是否认可单臂IGNYTE数据、加速批准路径和确认性试验要求。\\nAffected: REPL(subject\, unknown\, score 94)\; BMY(customer\, mixed\, score 48)\; MRK(peer\, mixed\, score 45)\; XBI(etf\, mixed\, score 62)\\nSources: Replimune FDA acceptance press release: https://ir.replimune.com/news-releases/news-release-details/replimune-announces-fda-acceptance-rp1-biologics-license\\nReplimune CRL background: https://ir.replimune.com/news-releases/news-release-details/replimune-receives-complete-response-letter-fda-rp1-biologics-0\\nFDA complete response letter PDF: 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-adcom-pdufa-2026
CATEGORIES:fda\,US\,FDA\,AdCom\,PDUFA\,melanoma\,oncolytic immunotherapy
SEQUENCE:0
BEGIN:VALARM
TRIGGER:-P1D
ACTION:DISPLAY
DESCRIPTION:Review catalyst preview: Replimune RP1晚期黑色素瘤BLA再提交审评与AdCom/PDUFA窗口
END:VALARM
BEGIN:VALARM
TRIGGER:PT24H
ACTION:DISPLAY
DESCRIPTION:Complete post-event review: Replimune RP1晚期黑色素瘤BLA再提交审评与AdCom/PDUFA窗口
END:VALARM
END:VEVENT
END:VCALENDAR