secwatch.observer — SEC 8-K summary
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Issuer:     Zymeworks Inc. (ZYME)
CIK:        0001937653
Form:       8-K
Filed at:   2026-05-07T23:59:59+00:00
Accession:  0001937653-26-000033
Event type: earnings
Sentiment:  neutral
Materiality: 0.80
Item codes: 2.02, 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Zymeworks Q1 net loss $44.2M; Jazz's zanidatamab sBLA accepted with Priority Review, PDUFA Aug 25, 2026
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- Jazz sBLA for zanidatamab in 1L HER2+ GEA accepted with Priority Review; PDUFA target date Aug 25, 2026.
- Upon US FDA approval, Zymeworks eligible for $250M milestone from Jazz; $15M from BeOne for China approval.
- Q1 2026 revenue $2.4M (down 91% YoY from $27.1M); net loss $44.2M vs $22.6M loss in Q1 2025.
- Cash and marketable securities $403.8M as of Mar 31, 2026; $95.8M used for share repurchases under $125M program.
- ZW191 Phase 1 data at AACR: 56% ORR in PROC, 61% in ovarian, 57% in endometrial; FDA Fast Track granted.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1937653/000193765326000033/0001937653-26-000033-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1937653/000193765326000033/zyme-20260507.htm
  HTML page:      https://secwatch.observer/filing/0001937653-26-000033

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