BeOne Medicines Ltd. ONC
BeOne Medicines Ltd. (Nasdaq: ONC) is an oncology drug developer. Its lead program, BRUKINSA (zanubrutinib), is in Phase 3 for CLL, MCL, WM, MZL, FL (B-cell malignancies). Its next catalyst on record is BGB-16673 (BTK-CDAC): Potential FDA accelerated approval submission based on Phase 2 in R/R CLL (2026).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: BGB-16673 (BTK-CDAC) — Potential FDA accelerated approval submission based on Phase 2 in R/R CLL (2026). 1 catalyst on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| BRUKINSA (zanubrutinib) | CLL, MCL, WM, MZL, FL | small molecule | Approved |
| BEQALZI (sonrotoclax) | R/R MCL (US accelerated approval); R/R CLL/SLL (China) | small molecule | Approved |
| TEVIMBRA | not stated in extract | unclear | Approved |
| BGB-16673 (BTK-CDAC) | CLL (R/R) | small molecule | Phase 3 |
| BRUKINSA + sonrotoclax | 1L CLL | small molecule | Phase 3 |
| BRUKINSA + rituximab (MANGROVE) | previously untreated MCL | small molecule | Phase 3 |
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 oncology companies
- Merck & Co., Inc. MRK
- Astrazeneca PLC AZN
- Bristol Myers Squibb Co BMY
- Revolution Medicines, Inc. RVMD
- Genmab A/S GMAB
- BioNTech SE BNTX
- Exelixis, Inc. EXEL
- Summit Therapeutics Inc. SMMT
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.