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Wednesday, Viracta Therapeutics Inc. (NASDAQ:VIRX) stock is trading higher after the company reported 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.
Twenty-one patients with primarily Stage III-IV disease received nanatinostat in combination with valganciclovir.
Additionally, the company received FDA feedback, which clarified the potential regulatory path to the initial registration of Nana-val in patients with R/R EBV+ PTCL.
Based on the FDA’s feedback, Viracta plans to begin a randomized controlled trial of Nana-val in the second half of 2025.
Viracta said it will focus Nana-val’s clinical development on patients with R/R EBV+ PTCL as follows:
Viracta believes this strategy will best position Nana-val for a potential NDA filing in 2026 for accelerated approval.
Viracta has aligned resources to prioritize its EBV+ lymphoma program.
Hence, the company has paused the EBV+ solid tumor program to focus resources on the more advanced EBV+ lymphoma program.
Along with this pipeline reprioritization, a force reduction has been implemented, which impacts approximately 23% of the company’s employees.
Price Action: VIRX stock is up 4.30% at $0.49 during the premarket session at last check Wednesday.
Photo via Shutterstock
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Posted In: VIRX