Viracta Obtains Orphan Drug Status From European Commission For T-cell Lymphoma Candidate

The European Commission has granted an orphan drug designation (ODD) to Viracta’s VIRX lead drug combination nanatinostat and valganciclovir (Nana-val) for the treatment of peripheral T-cell lymphoma (PTCL).

The Nana-val is being evaluated in the NAVAL-1 Phase 2 clinical trial for patients with relapsed/refractory Epstein-Barr virus-positive lymphoma.

The global Phase 2 NAVAL-1 trial is actively enrolling at sites across Europe, North America and Southeast Asia.

Lisa Rojkjaer, Chief Medical Officer, stated, "This orphan drug designation acknowledges the high unmet medical need of this patient population as well as the potential of the Nana-val o offer therapeutic benefit to patients with recurrent peripheral T-cell lymphoma.”

The U.S. Food and Drug Administration previously granted Nana-val orphan drug designation for the treatment of T-cell lymphoma.

The European Union grants orphan drug designation (ODD) to medicines  based on a positive opinion issued by the European Medicines Agency (EMA) Committee for Orphan Medical Products (COMP).

Price Action : Viracta shares are trading around 2 percent higher at $4.40 on Wednesday at the time of publication.