VIRX - Viracta Nana-val gets orphan drug status in EU for blood cancer subtype

• The European Commission (EC) granted an orphan drug designation (ODD) to Viracta Therapeutics' ( NASDAQ: VIRX ) all-oral combination product candidate Nana-val (nanatinostat and valganciclovir) to treat diffuse large B-cell lymphoma (DLBCL).
• The EC previously granted ODD to Nana-val for treating peripheral T-cell lymphoma. The therapy had previously received ODD from the U.S. Food and Drug Administration to treat T-cell lymphoma, post-transplant lymphoproliferative disorder, plasmablastic lymphoma, and Epstein-Barr virus-positive (EBV ⁺ ) DLBCL, not otherwise specified, according to the company.
• "Nana-val’s sixth orphan drug designation across the U.S. and Europe underscores the high unmet medical need for EBV-positive lymphoma patients worldwide, the broad therapeutic potential of its novel mechanism of action, and the global nature of our clinical and regulatory strategy," said Viracta President and CEO Mark Rothera.
• The orphan drug status in the EU is aimed at therapies for treating or preventing diseases which affect fewer than five in 10,000 people in the EU. The designation provides incentives, including 10 years' of market exclusivity for the drug, if approved.

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