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Vaxart (VXRT) FDA Events

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FDA Events for Vaxart (VXRT)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Vaxart (VXRT). Over the past two years, Vaxart has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as Bivalent and oral. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Vaxart's Drugs in FDA Review

Bivalent (Norovirus) - FDA Regulatory Timeline and Events

Bivalent (Norovirus) is a drug developed by Vaxart for the following indication: Norovirus Vaccine. 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.

oral pill COVID-19 - FDA Regulatory Timeline and Events

oral pill COVID-19 is a drug developed by Vaxart for the following indication: In adults previously immunized against COVID-19 infection. 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.

Vaxart FDA Events - Frequently Asked Questions

However, the company does has had drugs under review or in active clinical development.

In the past two years, Vaxart (VXRT) has reported FDA regulatory activity for the following drugs: Bivalent (Norovirus) and oral pill COVID-19.

The most recent FDA-related event for Vaxart occurred on March 11, 2025, involving Bivalent (Norovirus). The update was categorized as "Clinical Trial," with the company reporting: "Vaxart, Inc announced the initiation of a Phase 1, open label, dose ranging clinical trial evaluating its second-generation oral norovirus vaccine constructs head-to-head against its first-generation constructs."

Current therapies from Vaxart in review with the FDA target conditions such as:

  • Norovirus Vaccine - Bivalent (Norovirus)
  • In adults previously immunized against COVID-19 infection. - oral pill COVID-19

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:VXRT) was last updated on 7/11/2025 by MarketBeat.com Staff
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