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
- Oct 23, 2026accepted U.S. FDA granted IND clearance for ZW209 with additional global regulatory applications planned.
With U.S. Food and Drug Administration Investigational New Drug clearance received, a Phase 1, open-label, multicenter, global study investigating ZW209 has been initiated
Filing - Oct 23, 2026started Phase 1 open-label, multicenter, global study of ZW209 has been initiated to evaluate safety, tolerability, pharmacokinetics, and preliminary antitumor activity.
The study will enroll adult participants with select advanced solid tumors, including small cell lung cancer and other DLL3 expressing neuroendocrine tumors.
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
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.