BeOne Medicines Ltd. ONC
BeOne Medicines Ltd. (Nasdaq: ONC) is a hematology drug developer. Its lead program, zanubrutinib (BRUKINSA), is in Phase 3 for Chronic lymphocytic leukemia, Waldenström macroglobulinemia, mantle cell lymphoma, marginal zone lymphoma, follicular lymphoma.
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| zanubrutinib (BRUKINSA) | Multiple B-cell malignancies | small molecule | Approved |
| tislelizumab (TEVIMBRA) | Multiple solid tumor indications | antibody | Approved |
| zanidatamab (ZIIHERA) | HER2+ gastroesophageal adenocarcinoma (first-line with tislelizumab and chemotherapy) | antibody | Approved |
| zanidatamab (ZIIHERA - HERIZON-GEA-01) | HER2+ GEA first-line (combination with chemotherapy +/- tislelizumab) | antibody | Phase 3 |
| BTK CDAC | Not specified | small molecule | Phase 1 |
| CDK4 inhibitor | Not specified | small molecule | Phase 1 |
| PRMT5 inhibitor | Not specified | small molecule | Phase 1 |
| GPC3x4-1BB bsAb | Not specified | antibody | Phase 1 |
Recent results and decisions
- Nov 5, 2026met Pivotal Phase 2 portion of CaDAnCe-101 met its primary endpoint of overall response rate in patients with relapsed/refractory CLL.
Tacabrutideg (BTK CDAC): Pivotal Phase 2 portion of CaDAnCe-101 met its primary endpoint of overall response rate in patients with relapsed/refractory chronic lymphocytic leukemia (CLL).
Filing - Nov 5, 2026accepted BRUKINSA received U.S. FDA Priority Review designation for the Phase 3 MANGROVE filing.
Received U.S. Food and Drug Administration (FDA) Priority Review designation for the Phase 3 MANGROVE filing.
Filing - Nov 5, 2026approval TEVIMBRA received Japan regulatory approval for the treatment of adult patients with first-line nasopharyngeal cancer.
Received Japan regulatory approval for the treatment of adult patients with first-line nasopharyngeal cancer.
Filing
3 more on record.
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 3 hematology companies
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.