---
schema_version: "secwatch.filing_event.v1"
accession: "0001937653-26-000051"
form_type: "8-K"
ticker: "ZYME"
cik: "0001937653"
company_name: "Zymeworks Inc."
filed_at: "2026-08-25T14:54:11+00:00"
generated_at: "2026-08-25T14:55:09.329473+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.9
calibrated_materiality_score: 0.9
confidence: "high"
source: SEC EDGAR
---

# FDA approves zanidatamab combo for HER2+ GEA; Zymeworks earns $250M milestone

## Summary
- FDA approval of Ziihera (zanidatamab-hrii) with/without tislelizumab plus chemo in first-line HER2+ GEA triggers $250M milestone from Jazz.
- Zymeworks has now received $650M total upfront and milestone payments from Jazz; remains eligible for up to $1.3B more and 10-20% royalties.
- BeOne collaboration: $81M received to date; up to $144M additional milestones plus up to 19.5% royalties on sales.
- Approval based on Phase 3 HERIZON-GEA-01 trial (published in NEJM); second FDA approval for zanidatamab in under two years.

## SEC filing metadata
- accession: 0001937653-26-000051
- form_type: 8-K
- ticker: ZYME
- cik: 0001937653
- company_name: Zymeworks Inc.
- filed_at: 2026-08-25T14:54:11+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.9
- calibrated_materiality_score: 0.9
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1937653/000193765326000051/0001937653-26-000051-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1937653/000193765326000051/zyme-20260825.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001937653-26-000051
- JSON: https://secwatch.observer/filing/0001937653-26-000051.json
- Plain text: https://secwatch.observer/filing/0001937653-26-000051.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.