Pyxis Oncology, Inc. PYXS
Pyxis Oncology, Inc. (Nasdaq: PYXS) is an oncology drug developer. Its lead program, micvotabart pelidotin (MICVO, formerly PYX-201), is in Phase 2 for head and neck squamous cell carcinoma (HNSCC) – recurrent and metastatic (R/M). Its next catalyst on record is MICVO monotherapy: EORTC-NCI-AACR late-breaking oral presentation and posters (November 2026).
Upcoming catalysts
- November 2026MICVO monotherapy — EORTC-NCI-AACR late-breaking oral presentation and posters
In November 2026, data from our Phase 1 monotherapy study in previously treated R/M HNSCC are expected to be presented in a late-breaking oral presentation at the 38th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics
- December 2026MICVO + pembrolizumab — Corporate update with efficacy/safety data from at least 20 1L R/M HNSCC patients
We plan to provide a corporate update in December 2026 that we expect will outline a comprehensive development strategy for MICVO in R/M HNSCC… will include updated efficacy and safety data from the ongoing PYX-201-102 Phase 1/2 dose escalation study evaluating MICVO in combination with KEYTRUDA® (pembrolizumab) across
Next further out: MICVO monotherapy — End-of-Phase 2 FDA meeting feedback on dose selection (Q1 2027). 4 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| micvotabart pelidotin (MICVO) monotherapy | second-line and beyond R/M HNSCC | antibody | Phase 2 |
| MICVO + pembrolizumab (KEYTRUDA) combination | first-line / second-line and beyond R/M HNSCC and other solid tumors | antibody | Phase 1 |
| PYX-106 | Not specified (development paused December 2024, license terminated August 2026) | unclear | Pre-clinical |
Recent results and decisions
- Sep 9, 2026positive Positive Phase 1 update (N=33, data as of Aug 18, 2026): 36% confirmed ORR (12/33), 94% DCR, median PFS 6.2 months, 12-month OS 79%; 54% Grade 3+ TRAEs and 14% discontinuations (N=35).
MICVO data represented >5X improvement in ORR, >2X improvement on mPFS and significant improvement on mOS compared to historical control arm data in 2L+ R/M HNSCC
Filing - Dec 18, 2025positive Positive preliminary Phase 1 data: MICVO 5.4 mg/kg monotherapy showed 46% confirmed ORR (6/13) and 92% DCR in 2L+ R/M HNSCC; 56% Grade 3+ TRAEs, 28% discontinuations (data cutoff Nov 3, 2025).
46% confirmed objective response rate (ORR) and 92% disease control rate (DCR) observed with MICVO as monotherapy in 2L+ R/M HNSCC at 5.4 mg/kg
Filing
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 2 oncology companies
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.