The FDA has granted Fast Track designation to nemvaleukin alfa (nemvaleukin), a treatment of mucosal melanoma developed by Alkermes Plc (ALKS), reports John McCamant, biotech expert and editor of The Medical technology Stock Letter.
Nemvaleukin alfa (nemvaleukin) is a novel, investigational engineered interleukin-2 (IL-2) variant immunotherapy. Earlier this year, the FDA also granted orphan drug designation to nemvaleukin for the treatment of mucosal melanoma.
The company recently initiated enrollment in ARTISTRY-6, a global Phase II trial evaluating the anti-tumor activity, safety and tolerability of nemvaleukin monotherapy in patients with melanoma who have been previously treated with anti-PD-(L)1 therapy.
The study is evaluating intravenously administered nemvaleukin in patients with mucosal melanoma and subcutaneously administered nemvaleukin in patients with advanced cutaneous melanoma.
Nema has yet to be included in any Wall Street models and any good Phase II data will serve as a strong catalyst with fast track and orphan drug status both having been granted by the FDA.
Vivitrol sales were a surprise and have resumed to pre-COVID-19 levels. The primary Vivitrol driver has been the expanded use in alcohol dependent patinest along with better patient access and an improving net price. Looking ahead management expects Vivitrol alcohol dependence sales to increase in 2H21.
The company also believes that growing awareness of alcohol problems grew during COVID-19 and should drive longer-term segment growth.
We are pleased to see ALKS maintaining some momentum with a solid earnings call followed by good news with Nema being granted FDA fast track status. The stock is a buy under $35 with a target price of $55.
