FDA grants accelerated approval to Zymeworks' Ziihera for HER2+ BTC; $25M milestone earned

Zymeworks Inc.

Ziihera (zanidatamab-hrii) approved for adults with previously-treated unresectable/metastatic HER2+ BTC.
Approval based on 52% objective response rate and median DOR of 14.9 months from HERIZON-BTC-01 trial.
Zymeworks earns $25M milestone from Jazz; eligible for up to $500M regulatory + $862.5M commercial milestones.
Continued approval contingent on Phase 3 HERIZON-BTC-302 confirmatory trial.
Zanidatamab also in Phase 3 trials for GEA (top-line PFS data Q2 2025) and mBC.

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