iberdomide, daratumumab, and dexamethasone vs. daratumumab, bortezomib, and dexamethasone was approved by the FDA on August 13, 2026 for relapsed/refractory multiple myeloma (RRMM), the 32nd novel drug approval of 2026 on the FDA's Novel Drug Approvals list.
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
FDA record of the action: the FDA approved on August 13, 2026, per NDA 221075 ORIG-1 (FDA letter). The sponsor announced it the same day. Action dates on pdufa.bio come from the FDA's own record, not the press release. Every FDA action we hold, by FDA date: FDA approval letters.
| Fund | Shares | Value at quarter end | Filing |
|---|---|---|---|
| OrbiMed Advisors | 925,000 | $53.3 million | filed August 14, 2026 |
13F reports list long positions in common stock at quarter end, are due 45 days later, and show no short positions or later trades. Notes, warrants and other instruments are not counted as shares.
Yes. The FDA approved the application for ZENBEXUS (iberdomide) with daratumumab and hyaluronidase-fihj and dexa on August 13, 2026, per the FDA's own record. 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 FDA's own record of the decision 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.