Wednesday, Viracta Therapeutics Inc. ( 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.

As of the June 28 data cutoff, combined Stages 1 and 2 data demonstrated:

In the R/R EBV+ PTCL population: In the intent-to-treat (ITT) population (n=21), the overall response rate (ORR) was 33%, and the complete response rate (CRR) was 19%.

In the efficacy-evaluable (EE) population (n=17), the ORR was 41%, and the CRR was 24%.

In the second-line EBV+ PTCL subpopulation: The ORR was 60%, and the CRR was 30% in the ITT population (n=10).

The ORR was 67%, and the CRR was 33% in the EE population (n=9).

The median duration of response (DOR) has not yet been reached. Two responding patients proceeded to hematopoietic stem-cell transplant without relapse, one of whom remains in response over 16 months.

Nana-val was generally well-tolerated:

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:

First, the company will focus the primary analysis on the second-line EBV+ PTCL subpopulation in the ongoing NAVAL-1 trial’s expansion phase.

Second, the company plans to begin an RCT of Nana-val in 2025 for the second-line treatment of EBV+ PTCL patients.

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.

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