Alkermes Receives FDA Fast Track Status For Mucosal Melanoma Immunotherapy

by Vandana Singh, Benzinga Editor

August 2, 2021 8:53 AM | 1 min read | Make a Comment

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.