Viracta: FDA Grants Orphan Drug Designation For Nana-val In EBV-positive DLBCL

Viracta Therapeutics, Inc. (VIRX) announced the FDA has granted its all-oral combination product candidate, nanatinostat and valganciclovir (Nana-val), orphan drug designation for the treatment of Epstein Barr virus-positive diffuse large B-cell lymphoma, not otherwise specified.

Ivor Royston, CEO of Viracta, said: "Nana-val has shown promising preliminary efficacy across multiple subtypes of relapsed/refractory EBV-positive lymphoma, including diffuse large B-cell lymphoma. We are dosing patients in the pivotal NAVAL-1 trial, which includes patients with EBV-positive DLBCL, and look forward to its continued momentum with sites now open for enrollment in the U.S., Europe, and Asia."

Shares of Viracta Therapeutics were up 9% in pre-market trade on Monday.

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