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Viracta Therapeutics (VIRX) FDA Events

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As of 07/10/2025 03:51 PM Eastern
FDA Events for Viracta Therapeutics (VIRX)

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

Nanatinostat and Valganciclovir (Nana-val) - FDA Regulatory Timeline and Events

Nanatinostat and Valganciclovir (Nana-val) is a drug developed by Viracta Therapeutics for the following indication: Epstein Barr Virus-Positive Diffuse Large B-cell Lymphoma. 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.

Viracta Therapeutics FDA Events - Frequently Asked Questions

As of now, Viracta Therapeutics (VIRX) has not received any FDA approvals for its therapy in the last two years.

In the past two years, Viracta Therapeutics (VIRX) has reported FDA regulatory activity for Nanatinostat and Valganciclovir (Nana-val).

The most recent FDA-related event for Viracta Therapeutics occurred on August 14, 2024, involving Nanatinostat and Valganciclovir (Nana-val). The update was categorized as "Positive Results," with the company reporting: "Viracta Therapeutics, Inc reported positive Phase 2 NAVAL-1 trial results from Stages 1 and 2 of the relapsed or refractory (R/R) Epstein-Barr virus-positive (EBV+) peripheral T-cell lymphoma (PTCL) cohort. ."

Currently, Viracta Therapeutics has one therapy (Nanatinostat and Valganciclovir (Nana-val)) targeting the following condition: Epstein Barr Virus-Positive Diffuse Large B-cell Lymphoma.

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