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
The S&P 500 closed at 7,636.36 on 9 September 2026. Falling below 7,450 by month-end would require a 2.4% decline. Headwinds: Fed rate hike of 25bp on 16 September (CentralBank.Watch: 59% probability), August PPI above expectations (+5.4% YoY), Iran-Gulf risk premium. Stabilizing factors: hike largely priced in (Polymarket: 93% for zero 2026 cuts), Q2 earnings solid, no recession signals. Historically, a single 25bp September hike rarely causes a monthly decline above 2.5%.
📈 Economy
✦ AI
Polymarket shows a 53% probability for a 25 basis point hike as of September 10, 2026. US Core CPI August 2026 (release September 11) is expected by market consensus to be above 3.0% YoY. The ECB raised its deposit rate by 25 bps to 2.50% on September 10, 2026 – an inflation-fighting signal that provides cover for the Fed. Against a hike: a mild slowdown in US industrial output. CME FedWatch also shows ~53% probability for a hike.
📈 Economy
✦ AI
The DAX closed at 25,562 points on September 9, 2026. A gain of +1.7% is required by month-end. Headwinds: ECB rate hike to 2.50% (September 10), 53% FOMC hike probability (September 16), persistently high oil prices (~$101/barrel Brent) weigh on energy-intensive DAX heavyweights. Tailwinds: strong SAP cloud growth expected, robust US demand, EUR/USD at 1.1644 benefits exporters. Implied 30-day volatility (VDAX): ~16%, corresponding to a σ range of roughly ±5.5% by month-end — the 26,000 level falls within the central distribution.