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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-itm-177lu-edotreotide-gep-net-pdufa-august-2026@catalyst-calendar.local
DTSTAMP:20260720T200621Z
DTSTART:20260828T130000Z
DTEND:20260828T133000Z
SUMMARY:ITM-11放射性配体疗法GEP-NETs NDA FDA PDUFA窗口
DESCRIPTION:ITM的n.c.a. 177Lu-edotreotide（ITM-11）用于胃肠胰神经内分泌肿瘤的NDA已获FDA受理，PDUFA目标日期为2026年8月28日，事件可能影响放射性配体疗法产业链预期。\\nImpact score: 60\\nExpected: FDA决定将检验放射性配体疗法在神经内分泌肿瘤中的竞争和供应链可扩展性。\\nAffected: ITM.PVT(subject\, unknown\, score 80)\; NVS(peer\, mixed\, score 70)\; BMY(peer\, mixed\, score 55)\; LLY(peer\, mixed\, score 43)\; GEHC(supplier\, mixed\, score 36)\; IBB(etf\, mixed\, score 35)\\nSources: ITM NDA acceptance and PDUFA announcement: https://www.itm-radiopharma.com/news/press-releases/press-releases-detail/itm-announces-fda-acceptance-of-new-drug-application-nda-and-pdufa-date-for-n-c-a-177lu-edotreotide-itm-11-in-gastroenteropancreatic-neuroendocrine-tumors-gep-nets-747/\\nClinicalTrials.gov COMPETE study: https://clinicaltrials.gov/study/NCT03049189\\nOncLive summary of NDA acceptance: https://www.onclive.com/view/fda-accepts-nda-for-177lu-edotreotide-for-gep-nets\\nInformation only. Not investment advice.
URL:https://0.0.0.0:3000/?event=evt-itm-177lu-edotreotide-gep-net-pdufa-august-2026
CATEGORIES:fda\,US\,FDA\,PDUFA\,radioligand therapy\,GEP-NET\,177Lu\,radiopharma\,radioligand-therapy
SEQUENCE:0
BEGIN:VALARM
TRIGGER:-P1D
ACTION:DISPLAY
DESCRIPTION:Review catalyst preview: ITM-11放射性配体疗法GEP-NETs NDA FDA PDUFA窗口
END:VALARM
BEGIN:VALARM
TRIGGER:PT24H
ACTION:DISPLAY
DESCRIPTION:Complete post-event review: ITM-11放射性配体疗法GEP-NETs NDA FDA PDUFA窗口
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