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PRODID:-//Catalyst Calendar//CN-US Event Research//ZH
CALSCALE:GREGORIAN
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X-WR-CALNAME:Catalyst Calendar
X-WR-CALDESC:Market-moving event research, reminders and post-event review.
BEGIN:VEVENT
UID:evt-bms-iberdomide-pdufa-august-2026@catalyst-calendar.local
DTSTAMP:20260720T200520Z
DTSTART:20260817T120000Z
DTEND:20260817T123000Z
SUMMARY:Bristol Myers Squibb iberdomide复发/难治多发性骨髓瘤NDA PDUFA窗口
DESCRIPTION:FDA已受理BMS iberdomide联合daratumumab/dexamethasone用于复发/难治多发性骨髓瘤的NDA，PDUFA日期为2026年8月17日；事件将检验CELMoD平台在来那度胺/泊马度胺后时代的商业化潜力。\\nImpact score: 68\\nExpected: FDA决定是否批准iberdomide联合方案；市场关注MRD/PFS证据、血液肿瘤竞争和BMS后Revlimid时代增长资产。\\nAffected: BMY(subject\, mixed\, score 82)\; PFE(subject\, unknown\, score 70)\; MRK(subject\, unknown\, score 68)\; ALPMY(subject\, unknown\, score 60)\; JNJ(peer\, mixed\, score 55)\; NVS(peer\, mixed\, score 55)\\nSources: Bristol Myers Squibb NDA acceptance PR: https://news.bms.com/news/corporate-financial/2026/U-S--Food-and-Drug-Administration-Accepts-Bristol-Myers-Squibbs-New-Drug-Application-for-Iberdomide-in-Patients-with-Relapsed-or-Refractory-Multiple-Myeloma/default.aspx\\nBMS clinical trial EXCALIBER-RRMM: https://www.bmsclinicaltrials.com/us/en/clinical-trials/NCT04975997\\nInternational Myeloma Foundation summary: https://www.myeloma.org/news-events/multiple-myeloma-news/fda-accepts-new-drug-application-iberdomide-rrmm\\nPfizer Padcev Keytruda priority review: https://www.pfizer.com/news/press-release/press-release-detail/us-fda-grants-priority-review-sbla-padcevtm-keytrudar\\nMerck Keytruda Padcev review: https://www.merck.com/news/fda-grants-priority-review-for-keytruda-pembrolizumab-and-keytruda-qlex-pembrolizumab-and-berahyaluronidase-alfa-pmph-each-with-padcev-enfortumab-vedotin-ejfv-for-cisplati/\\nClinicalTrials.gov EXCALIBER-RRMM: https://clinicaltrials.gov/study/NCT04975997\\nBMS iberdomide FDA acceptance: https://investors.bms.com/iframes/press-releases/press-release-details/2026/U-S--Food-and-Drug-Administration-Accepts-Bristol-Myers-Squibbs-New-Drug-Application-for-Iberdomide-in-Patients-with-Relapsed-or-Refractory-Multiple-Myeloma/default.aspx\\nBMS Q1 2026 investor presentation: https://www.bms.com/assets/bms/us/en-us/pdf/investor-info/doc_presentations/2026/BMY-2026-Q1-Results-Investor-Presentation-with-Appendix.pdf\\nInformation only. Not investment advice.
URL:https://0.0.0.0:3000/?event=evt-bms-iberdomide-pdufa-august-2026
CATEGORIES:fda\,US\,FDA\,PDUFA\,multiple myeloma\,CELMoD\,MRD\,hematology\,多发性骨髓瘤\,Project Orbis\,血液肿瘤\,oncology\,bladder cancer\,ADC\,protein degradation
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DESCRIPTION:Review catalyst preview: Bristol Myers Squibb iberdomide复发/难治多发性骨髓瘤NDA PDUFA窗口
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DESCRIPTION:Complete post-event review: Bristol Myers Squibb iberdomide复发/难治多发性骨髓瘤NDA PDUFA窗口
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