---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-26-385901"
form_type: "8-K"
ticker: "PYXS"
cik: "0001782223"
company_name: "Pyxis Oncology, Inc."
filed_at: "2026-09-09T11:34:45+00:00"
generated_at: "2026-09-09T11:40:07.217042+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Pyxis Oncology reports 36% cORR, 94% DCR for MICVO in 2L+ HNSCC; Phase 3 planned mid-2027

## Summary
- 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.

## SEC filing metadata
- accession: 0001193125-26-385901
- form_type: 8-K
- ticker: PYXS
- cik: 0001782223
- company_name: Pyxis Oncology, Inc.
- filed_at: 2026-09-09T11:34:45+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1782223/000119312526385901/0001193125-26-385901-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1782223/000119312526385901/pyxs-20260909.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-26-385901
- JSON: https://secwatch.observer/filing/0001193125-26-385901.json
- Plain text: https://secwatch.observer/filing/0001193125-26-385901.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.