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.
Market News and Data brought to you by Benzinga APIs
Comments
Loading...
Posted In: BiotechNewsHealth CareFDAGeneralBriefsFDA Fast Trackmelanoma
Benzinga simplifies the market for smarter investing

Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.

Join Now: Free!