FDA approves iberdomide (Bristol Myers Squibb, NYSE: BMY) for relapsed/refractory multiple myeloma by PDUFA date August 17, 2026
Hit
✦ AI-generated prediction
Published on 24. July 2026
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Predicted for 17. August 2026
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Based on: Statistical Pattern
The PDUFA date for iberdomide (combination with daratumumab + dexamethasone, EXCALIBER-RRMM Phase 3 study) is August 17, 2026. BMS received both Breakthrough Therapy and Priority Review designation – both signals of strong regulatory support. The FDA historically approves ~83–87% of applications reaching a PDUFA date; with Breakthrough Therapy designation the rate is even higher (>90%). No negative Advisory Committee signal is known. Cassandra estimates the approval probability at 78% (slight discount vs historical average for a complex combination therapy).
Data basis for this prediction
- BMS FDA-Zulassungsantrag Iberdomide bestätigt: PDUFA 17. August 2026 – BMS Pressemitteilung (bms.com 2026)
- FDA Breakthrough Therapy + Priority Review Designation Iberdomide – BMS / Neurology Advisor (2026)
- EXCALIBER-RRMM Phase-3-Studie: positives PFS-Ergebnis – Life Science Daily News / BMS (2026)
- FDA PDUFA-Zulassungsrate bei Breakthrough Therapy: >90 %, FDA Drug Approvals Report 2015–2025
Note: This is an AI-generated statistical forecast for entertainment and information purposes. It does not constitute investment advice or a recommendation to buy or sell any financial instrument.
Verdict: Hit
Die FDA erteilte am 13. August 2026 – vier Tage vor dem PDUFA-Datum (17. August 2026) – eine Accelerated Approval für Iberdomide (Handelsname: Zenbexus, BMS) in Kombination mit Daratumumab/Hyaluronidase-fihj und Dexamethason für rezidiviertes/refraktäres Multiples Myelom (≥1 Vorbehandlung mit PI und IMiD). Basis war die EXCALIBER-RRMM Phase-3-Studie, Surrogatendpunkt MRD-negative CR. Die Vorhersage trat somit vollständig ein – Zulassung vor dem PDUFA-Datum, exakt die beantragte Indikation und Kombination. Quellen: FDA.gov (https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-iberdomide-daratumumab-and-hyaluronidase-fihj-and-dexamethasone), OncoDaily, HealthTree (08-13-2026).
📈 Economy
✦ AI
Take-Two Interactive reports Q2 FY2027 (July–September 2026) results on November 9 after market close. Estimated analyst consensus: approx. -$0.45 EPS (heavy investment cycle around GTA VI and other AAA titles). TTWO has beaten consensus in 6 of the last 8 quarters; strong Recurrent Consumer Spending base (mobile, NBA 2K, GTA Online) consistently delivers positive surprises on cost discipline. Report date confirmed by TipRanks Earnings Calendar (as of Nov 8, 2026). Verification by TTWO Investor Relations or Bloomberg by November 10, 2026, 10:00 ET.
📈 Economy
✦ AI
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📈 Economy
✦ AI
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