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.
- Drug:
- Nanatinostat and Valganciclovir (Nana-val)
- Announced Date:
- August 14, 2024
- Indication:
- Epstein Barr Virus-Positive Diffuse Large B-cell Lymphoma
Announcement
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. .
AI Summary
Viracta Therapeutics recently announced positive results from Stages 1 and 2 of the Phase 2 NAVAL-1 trial in patients with relapsed or refractory Epstein‐Barr virus-positive peripheral T-cell lymphoma (EBV+ PTCL). The trial showed that the investigational treatment Nana-val, an oral combination of nanatinostat and valganciclovir, demonstrated substantial antitumor activity along with a generally well-tolerated safety profile. In this group, the overall response rates were promising—with a 33% response rate in the intent-to-treat population and even higher rates observed in the second-line treatment subgroup. The median duration of response has not yet been reached, indicating durable clinical benefits. These encouraging findings support Nana-val’s potential to address unmet needs in this aggressive cancer, and Viracta plans to advance its clinical development with a randomized controlled trial starting in the second half of 2025.
Read Announcement- Drug:
- Nanatinostat and Valganciclovir (Nana-val)
- Announced Date:
- April 15, 2024
- Indication:
- Epstein Barr Virus-Positive Diffuse Large B-cell Lymphoma
Announcement
Viracta Therapeutics, Inc reported positive topline results from Stage 1 of the pivotal Phase 2 NAVAL-1 trial from both arms of the relapsed or refractory (R/R) Epstein-Barr virus-positive (EBV+) peripheral T-cell lymphoma (PTCL) cohort.
AI Summary
Viracta Therapeutics, Inc. reported positive topline results from Stage 1 of its pivotal Phase 2 NAVAL-1 trial in patients with relapsed or refractory Epstein-Barr virus-positive peripheral T-cell lymphoma (PTCL). The trial compared two treatment arms: one with nanatinostat monotherapy and one combining nanatinostat with valganciclovir (Nana-val). The results showed that patients in the Nana-val combination arm experienced clinically meaningful anti-tumor responses, with a 50% overall response rate and a 20% complete response rate in the intent-to-treat population. In a subset of patients who could be evaluated for efficacy, these rates were even higher. The data support Nana-val’s ‘Kick and Kill’ mechanism of action and highlight its potential as a well-tolerated, all-oral treatment option for patients with this difficult-to-treat cancer. Additional data and further trial progress are expected soon.
Read Announcement
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
FDA Event Stage Terminology & Abbreviation Guide
- 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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