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 1 for Recurrent/metastatic head and neck squamous cell carcinoma (2L+ monotherapy; 1L/2L+ with pembrolizumab) and other solid tumors. Its next catalyst on record is MICVO + pembrolizumab: Updated clinical data from Phase 1/2 dose escalation, focused on 1L R/M HNSCC (Q4 2026).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: MICVO + pembrolizumab — Updated clinical data from Phase 1/2 dose escalation, focused on 1L R/M HNSCC (Q4 2026). 3 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| MICVO monotherapy (PYX-201-101) | R/M HNSCC 2L+ (Phase 1 dose expansion at 5.4 mg/kg Q3W; ~40 patients enrolled Q1 2026) | antibody | Phase 1 |
| MICVO + pembrolizumab (PYX-201-102) | 1L/2L+ R/M HNSCC and other solid tumors (Phase 1/2, dose escalation ongoing) | antibody | Phase 1 |
| PYX-106 (Siglec-15 antibody) | Solid tumors (clinical development paused December 2024) | antibody | Phase 1 |
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 - Sep 9, 2026n/a Company says Phase 3 design in 2L+ R/M HNSCC (ORR and OS primary endpoints, ~500 patients) is aligned with FDA and EMA feedback.
Aligned with FDA and EMA feedback on trial design in 2L+ patients
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
1 more on record.
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 1 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.