VIRX - Viracta Therapeutics stock jumps 9% on Orphan Drug tag in U.S. for Nana-val
The FDA grants orphan drug designation (ODD) to Viracta Therapeutics' (NASDAQ:VIRX) all-oral combination product candidate, nanatinostat and valganciclovir (Nana-val), for the treatment of Epstein Barr virus-positive diffuse large B-cell lymphoma, not otherwise specified (EBV+ DLBCL, NOS). Shares up 8.5% premarket at $5.25. Among the benefits of Orphan Drug status in the U.S. is a seven-year period of market exclusivity for the indication, if approved. "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," said Ivor Royston, M.D., President and CEO of Viracta. DLBCL is the most common subtype of non-Hodgkin lymphoma. Viracta has previously received ODD in U.S. for the treatment of T-cell lymphoma, post-transplant lymphoproliferative disorder and plasmablastic lymphoma.
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Viracta Therapeutics stock jumps 9% on Orphan Drug tag in U.S. for Nana-val