Zymeworks Inc. ZYME
Zymeworks Inc. (Nasdaq: ZYME) is an oncology drug developer. Its lead program, ZW191, is in Phase 1 for Folate receptor-alpha expressing solid tumors.
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| ZW191 | FRalpha solid tumors | antibody | Phase 1 |
Recent results and decisions
- Aug 6, 2026n/a FDA granted Breakthrough Therapy Designation to zanidatamab for previously treated HER2+ colorectal cancer.
The FDA granted Breakthrough Therapy Designation (BTD) for zanidatamab (Ziihera®), for the treatment of adults with previously treated, locally advanced, unresectable, or metastatic HER2-positive colorectal cancer.
Filing - May 7, 2026accepted FDA accepted Jazz sBLA for zanidatamab in 1L HER2+ GEA with Priority Review; PDUFA date August 25, 2026.
In April 2026, the U.S. FDA accepted our partner Jazz’s sBLA filing for Ziihera® (zanidatamab-hrii) combinations
Filing - May 7, 2026accepted Ex-US regulatory: China NMPA accepted the sBLA for zanidatamab in 1L HER2+ GEA (filed by BeOne).
China’s NMPA has accepted the sBLA for zanidatamab; the U.S. FDA has granted Breakthrough Therapy Designation to zanidatamab in combination with fluoropyrimidine- and platinum-based chemotherapy (±) TEVIMBRA, for this indication.
Filing
4 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 1 oncology 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.