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Vir Biotechnology (VIR) FDA Events

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FDA Events for Vir Biotechnology (VIR)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Vir Biotechnology (VIR). Over the past two years, Vir Biotechnology has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as tobevibart, Tobevibart, VIR-3434, VIR-5818, and XTEN. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Vir Biotechnology's Drugs in FDA Review

tobevibart - FDA Regulatory Timeline and Events

tobevibart is a drug developed by Vir Biotechnology for the following indication: For Chronic Hepatitis Delta. 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.

Tobevibart and Elebsiran - FDA Regulatory Timeline and Events

Tobevibart and Elebsiran is a drug developed by Vir Biotechnology for the following indication: For the Treatment of Chronic Hepatitis Delta 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.

VIR-3434 - FDA Regulatory Timeline and Events

VIR-3434 is a drug developed by Vir Biotechnology for the following indication: Chronic Hepatitis B virus 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.

VIR-5818 - FDA Regulatory Timeline and Events

VIR-5818 is a drug developed by Vir Biotechnology for the following indication: In metastatic castration-resistant prostate cancer (mCRPC). 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.

XTEN - FDA Regulatory Timeline and Events

XTEN is a drug developed by Vir Biotechnology for the following indication: For oncology and infectious disease. 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.

Vir Biotechnology FDA Events - Frequently Asked Questions

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

In the past two years, Vir Biotechnology (VIR) has reported FDA regulatory activity for the following drugs: Tobevibart and Elebsiran, tobevibart, VIR-5818, XTEN and VIR-3434.

The most recent FDA-related event for Vir Biotechnology occurred on May 9, 2025, involving Tobevibart and Elebsiran. The update was categorized as "Provided Update," with the company reporting: "Vir Biotechnology, Inc. announced 24-week post-end of treatment data from Part B of the ongoing MARCH Phase 2 clinical study evaluating tobevibart and elebsiran without or with pegylated interferon alpha (PEG-IFNα) in participants with chronic hepatitis B (CHB)."

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

  • For the Treatment of Chronic Hepatitis Delta Infection - Tobevibart and Elebsiran
  • For Chronic Hepatitis Delta - tobevibart
  • In metastatic castration-resistant prostate cancer (mCRPC). - VIR-5818
  • For oncology and infectious disease - XTEN
  • Chronic Hepatitis B virus infection - VIR-3434

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:VIR) was last updated on 7/10/2025 by MarketBeat.com Staff
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