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Pyxis Oncology (PYXS) FDA Events

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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.

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

  • 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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