Fourth U.S. FDA orphan drug designation granted for Nana-val
First Orphan Drug Designation for EBV-Positive diffuse large B-cell lymphoma granted by U.S. FDA
Viracta Therapeutics, Inc. (Nasdaq: VIRX), a precision oncology company targeting virus-associated malignancies, today announced that the U.S. Food and Drug Administration (FDA) has granted its all-oral combination product candidate, nanatinostat and valganciclovir (Nana-val), orphan drug designation (ODD) for the treatment of Epstein Barr virus-positive diffuse large B-cell lymphoma, not otherwise specified (EBV+ DLBCL, NOS). DLBCL is the most common subtype of non-Hodgkin lymphoma (NHL) in the U.S. and worldwide, accounting for approximately 25% of newly diagnosed cases of NHL in the U.S, of which a subset are EBV+. Viracta has previously received ODD from the FDA for the treatment of T-cell lymphoma, post-transplant lymphoproliferative disorder (PTLD) and plasmablastic lymphoma.
https://finance.yahoo.com/news/viracta-therapeutics-announces-orphan-drug-130000267.html
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