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

Zymeworks Inc.

• 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.