This section highlights FDA-related milestones and regulatory updates for drugs developed by Pyxis Oncology (PYXS).
Over the past two years, Pyxis Oncology has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
MICVO and PYX-201. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
MICVO FDA Regulatory Events
MICVO is a drug developed by Pyxis Oncology for the following indication: Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- MICVO
- Announced Date:
- December 18, 2025
- Indication:
- Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
Announcement
Pyxis Oncology, Inc. announced positive preliminary data from its ongoing Phase 1 clinical studies evaluating micvotabart pelidotin (MICVO), a first-in-concept antibody-drug conjugate (ADC) targeting extradomain-B of fibronectin (EDB+FN), a non-cellular structural component of the tumor extracellular matrix (ECM), in patients with recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC).
AI Summary
Pyxis Oncology reported encouraging preliminary Phase 1 results for micvotabart pelidotin (MICVO) in recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC). In the monotherapy expansion at 5.4 mg/kg, 18 patients were treated and 13 were evaluable: confirmed overall response rate (ORR) was 46% (6/13) including one complete response, and disease control rate (DCR) was 92% (12/13). These patients were heavily pretreated (median three prior lines) and all had prior platinum and checkpoint inhibitor therapy. MICVO was generally tolerated; no Grade 4 or 5 ADC payload events were reported. Adverse events led to discontinuation in some patients, often those with higher bodyweight, and the company plans adjusted-ideal-bodyweight dosing going forward.
In combination with pembrolizumab (3.6–4.4 mg/kg), seven R/M HNSCC patients showed a 71% confirmed ORR (5/7) and 100% DCR (7/7), including responses across PD‑(L)1 scores and in prior checkpoint‑treated patients. The combo was well tolerated with no ADC payload Grade 3/4 events or discontinuations observed. Pyxis expects updated monotherapy data mid‑2026 and additional combination data in the second half of 2026.
Read Announcement
PYX-201 FDA Regulatory Timeline and Events
PYX-201 is a drug developed by Pyxis Oncology for the following indication: In multiple types of solid tumors.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- PYX-201
- Announced Date:
- April 25, 2025
- Indication:
- In multiple types of solid tumors
Announcement
Pyxis Oncology, Inc. announced robust preclinical data supporting the unique extracellular linker payload cleaving mechanism of action of micvotabart pelidotin (MICVO, formerly referred to as PYX-201) and validating MICVO's ongoing clinical development. MICVO is a first-in-concept antibody-drug conjugate (ADC) that targets Extradomain-B Fibronectin (EDB+FN), a non-cellular structural component of the tumor extracellular matrix.
AI Summary
Pyxis Oncology recently shared robust preclinical data supporting the unique extracellular linker payload cleaving mechanism of micvotabart pelidotin (MICVO, formerly PYX-201). MICVO is a novel antibody-drug conjugate (ADC) that targets Extradomain-B Fibronectin (EDB+FN), a structural component found mostly in tumor extracellular matrices rather than healthy tissues. The data validates MICVO’s ongoing clinical development by showing that enhanced linker cleavage, identified through differential gene expression analysis, contributes to its anti-tumor activity. Preclinical studies using mouse models revealed that MICVO’s cytotoxic payload effectively destroys tumor cells and even boosts immune responses, with evidence suggesting that it can generate lasting immunological memory. These promising findings support MICVO’s potential as a stand-alone treatment and in combination with anti-PD-1 therapy, offering a fresh approach for tackling difficult-to-treat solid tumors.
Read Announcement- Drug:
- PYX-201
- Announced Date:
- March 25, 2025
- Indication:
- In multiple types of solid tumors
Announcement
Pyxis Oncology, Inc. announced that the Company will present new, positive preclinical data highlighting the potential of micvotabart pelidotin (MICVO, formerly referred to as PYX-201), a first-in-concept antibody-drug conjugate (ADC) that targets EDB+FN, a non-cellular structural component of the tumor extra-cellular matrix.
AI Summary
Pyxis Oncology, Inc. announced that it will present positive new preclinical data at the upcoming AACR Annual Meeting, showcasing the potential of its novel drug candidate, micvotabart pelidotin (MICVO, formerly known as PYX-201). MICVO is a first-in-concept antibody-drug conjugate designed to target EDB+FN, a non-cellular structural component of the tumor extracellular matrix. The preclinical studies conducted with patient-derived xenograft mouse models have identified specific gene signatures associated with MICVO’s anti-tumor activity, deepening the understanding of the drug’s mechanism of action. By targeting the tumor’s support structure, MICVO may reduce resistance to therapy and improve treatment outcomes. These encouraging findings support the company’s efforts to advance MICVO into both monotherapy and combination clinical trials, particularly for recurrent and metastatic head and neck squamous cell carcinoma.
Read Announcement- Drug:
- PYX-201
- Announced Date:
- February 26, 2025
- Indication:
- In multiple types of solid tumors
Announcement
Pyxis Oncology, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to PYX-201 for the treatment of adult patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) whose disease has progressed following treatment with platinum-based chemotherapy and an anti-PD-(L)1 antibody.
AI Summary
Pyxis Oncology, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to its investigational drug PYX-201. This designation is for the treatment of adult patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) whose cancer worsened after platinum-based chemotherapy and treatment with an anti-PD-(L)1 antibody. Fast Track Designation is intended to speed up the development and review of treatments for serious conditions, highlighting the urgent need for better options in this hard-to-treat cancer.
PYX-201 is a novel antibody-drug conjugate that targets a unique component in the tumor’s extracellular matrix. Pyxis Oncology plans to move forward quickly, actively recruiting patients for clinical trials to evaluate the therapy’s potential benefit in combating this aggressive cancer type.
Read Announcement- Drug:
- PYX-201
- Announced Date:
- February 4, 2025
- Indication:
- In multiple types of solid tumors
Announcement
Pyxis Oncology, Inc. announced significant progress in its clinical program for PYX-201, a first-in-concept antibody-drug conjugate (ADC) that uniquely targets Extradomain-B Fibronectin (EDB+FN), a non-cellular structural component within the tumor extracellular matrix (ECM), which is highly expressed in various tumor types.
AI Summary
Pyxis Oncology is reporting significant progress with PYX-201, a novel antibody-drug conjugate (ADC) that targets Extradomain-B Fibronectin (EDB+FN). This protein is a non-cellular part of the tumor’s extracellular matrix and is highly present in many cancer types. By focusing on EDB+FN, PYX-201 is designed to deliver its cancer-killing payload directly into the tumor environment. This targeted approach may help induce cell death and promote an immune response against the tumor.
The clinical program includes two active trials. One study is testing PYX-201 alone in patients with recurrent or metastatic head and neck squamous cell carcinoma, while a second trial is examining the combination of PYX-201 with Merck’s KEYTRUDA®. These trials aim to offer new treatment options for patients with advanced solid tumors who currently have limited therapies available.
Read Announcement- Drug:
- PYX-201
- Announced Date:
- December 19, 2024
- Indication:
- In multiple types of solid tumors
Announcement
Pyxis Oncology, Inc. announced a portfolio prioritization, focusing resources on advancing its lead clinical program, PYX-201, a first-in-concept antibody-drug conjugate (ADC) with a microtubule inhibitor (optimized auristatin) payload that uniquely targets Extradomain-B Fibronectin (EDB+FN), a non-cellular structural component within the tumor extracellular matrix.
AI Summary
Pyxis Oncology, Inc. announced a strategic shift by prioritizing its lead clinical asset, PYX-201. This innovative, first-in-concept antibody-drug conjugate (ADC) features a microtubule inhibitor (optimized auristatin) payload and uniquely targets Extradomain-B Fibronectin (EDB+FN) within the tumor extracellular matrix. The move comes after promising early clinical data demonstrated significant RECIST responses in head and neck squamous cell carcinoma, along with potential activity in other solid tumors. The company plans to advance PYX-201 in multiple trials, including monotherapy and combination therapy with pembrolizumab, with patient dosing expected to begin in early 2025. Pyxis Oncology’s focused approach is aimed at efficiently utilizing resources, with current funding anticipated to support development through the second half of 2026.
Read Announcement
