ZENBEXUS (iberdomide), the first FDA-approved CELMoD (cereblon E3 ligase modulator), granted accelerated approval on August 13, 2026 in combination with daratumumab and hyaluronidase-fihj and dexamethasone - four days ahead of its August 17 PDUFA goal date.
The PDUFA target action date was August 17, 2026; the FDA granted accelerated approval on August 13. Efficacy came from the Phase 3 EXCALIBER-RRMM trial (NCT04975997, 939 patients randomized): the MRD-negative complete response rate at any time was 41% with iberdomide plus daratumumab/hyaluronidase and dexamethasone versus 21% for the daratumumab/bortezomib/dexamethasone comparator (p<0.0001) in the 420-patient primary efficacy population. Progression-free survival remains under evaluation as the confirmatory clinical-benefit endpoint. The label carries a boxed warning for embryo-fetal toxicity and serious venous and arterial thromboembolism, with warnings for neutropenia, infections and second primary malignancies; the drug is available only through the ZENBEXUS REMS. The application held priority review plus breakthrough therapy and orphan drug designations, and was reviewed under Project Orbis with Swissmedic.
Run-up figures are the stock's own daily closing path over the 120 trading days before the decision, from our price history. Cohort move is the historical median absolute decision-day move for this market-cap tier. History, not a prediction.
Primary source: FDA approval notice, August 13, 2026
Yes. The FDA approved the application for ZENBEXUS (iberdomide) with daratumumab and hyaluronidase-fihj and dexa on August 13, 2026. The primary source is linked on this page.
ZENBEXUS (iberdomide) with daratumumab and hyaluronidase-fihj and dexa is a Bristol-Myers Squibb Company (BMY) program. The FDA decision came on August 13, 2026; the company's own announcement is linked on this page.
Measured over the 120 trading days before the decision (T-120 to T-1), BMY moved +8.6%. That is the recorded price path into this specific event -- historical measurement, not a prediction, and not investment advice.