Alkermes Receives FDA Fast Track Status For Mucosal Melanoma Immunotherapy
- The FDA has granted Fast Track designation to Alkermes plc's (NASDAQ: 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.
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