secwatch.observer — SEC 8-K summary
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Issuer:     Pyxis Oncology, Inc. (PYXS)
CIK:        0001782223
Form:       8-K
Filed at:   2026-09-09T11:34:45+00:00
Accession:  0001193125-26-385901
Event type: other_material
Sentiment:  positive
Materiality: 0.85
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Pyxis Oncology reports 36% cORR, 94% DCR for MICVO in 2L+ HNSCC; Phase 3 planned mid-2027
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- MICVO Phase 1 in 2L+ R/M HNSCC: cORR 36% (12/33), DCR 94% (31/33), mPFS 6.2 months, 12-month OS 79%.
- Median OS not reached; 83% of responders had >50% tumor reduction; 75% responded by first scan at 6 weeks.
- No new safety signals; dose capping reduced frequency/severity of AEs in high body weight patients; no treatment-related deaths.
- Phase 3 Headliner trial planned to initiate mid-2027; FDA/EMA aligned on design; End of Phase 2 meeting Q1 2027.
- Combination with KEYTRUDA data expected Q4 2026; updated OS data from monotherapy expected H1 2027.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1782223/000119312526385901/0001193125-26-385901-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1782223/000119312526385901/pyxs-20260909.htm
  HTML page:      https://secwatch.observer/filing/0001193125-26-385901

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