secwatch.observer — SEC 8-K summary
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Issuer:     Zymeworks Inc. (ZYME)
CIK:        0001937653
Form:       8-K
Filed at:   2024-11-21T23:59:59+00:00
Accession:  0001193125-24-263398
Event type: regulatory
Sentiment:  positive
Materiality: 0.85
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1937653/000119312524263398/0001193125-24-263398-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1937653/000119312524263398/d769907d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-24-263398

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer