FDA Events for Pyxis Oncology (PYXS)
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
PYX-201. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
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
Pyxis Oncology FDA Events - Frequently Asked Questions
As of now, Pyxis Oncology (PYXS) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Pyxis Oncology (PYXS) has reported FDA regulatory activity for PYX-201.
The most recent FDA-related event for Pyxis Oncology occurred on April 25, 2025, involving PYX-201. The update was categorized as "Preclinical Data," with the company reporting: "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."
Currently, Pyxis Oncology has one therapy (PYX-201) targeting the following condition: In multiple types of solid tumors.
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NASDAQ:PYXS) was last updated on 7/11/2025 by MarketBeat.com Staff
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