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Atea Pharmaceuticals (AVIR) FDA Events

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FDA Events for Atea Pharmaceuticals (AVIR)

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

Bemnifosbuvir - FDA Regulatory Timeline and Events

Bemnifosbuvir is a drug developed by Atea Pharmaceuticals for the following indication: COVID-19. 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.

Atea Pharmaceuticals FDA Events - Frequently Asked Questions

As of now, Atea Pharmaceuticals (AVIR) has not received any FDA approvals for its therapy in the last two years.

In the past two years, Atea Pharmaceuticals (AVIR) has reported FDA regulatory activity for Bemnifosbuvir.

The most recent FDA-related event for Atea Pharmaceuticals occurred on June 24, 2025, involving Bemnifosbuvir. The update was categorized as "Dose Update," with the company reporting: "Atea Pharmaceuticals, Inc. announced that the first patient was dosed in the global Phase 3 C-FORWARD trial evaluating the combination regimen of bemnifosbuvir and ruzasvir compared to the regimen of sofosbuvir and velpatasvir for the treatment of hepatitis C virus (HCV)."

Currently, Atea Pharmaceuticals has one therapy (Bemnifosbuvir) targeting the following condition: 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:AVIR) was last updated on 7/9/2025 by MarketBeat.com Staff
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