Alkermes Receives FDA Fast Track Status For Mucosal Melanoma Immunotherapy

The FDA has granted Fast Track designation to Alkermes plc's ALKS nemvaleukin alfa (nemvaleukin) for mucosal melanoma.
Nemvaleukin is an investigational engineered interleukin-2 (IL-2) variant immunotherapy.
Earlier this year, the FDA also granted orphan drug designation to nemvaleukin for mucosal melanoma.
The Company recently initiated enrollment in ARTISTRY-6 Phase 2 trial evaluating the anti-tumor activity, safety, and tolerability of nemvaleukin monotherapy in patients who have been previously treated with anti-PD-(L)1 therapy.
Price Action: ALKS shares are up 1.8% at $26.34 during the premarket session on the last check Monday.
Related content: Benzinga's Full FDA Calendar.