On August 2nd, 2021, Alkermes plc (Nasdaq: ALKS) announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to nemvaleukin alfa (nemvaleukin) - the company's novel, investigational engineered interleukin-2 (IL-2) variant immunotherapy, for the treatment of mucosal melanoma.

“Receiving Fast Track designation from the FDA for nemvaleukin for the treatment of mucosal melanoma is an important milestone for the nemvaleukin development program and underscores nemvaleukin's potential clinical utility to address an unmet medical need in this difficult-to-treat tumor type,” said Chris Hutchinson, the company’s Chief Medical Officer.

Earlier this year, nemvaleukin was also granted orphan drug designation for the treatment of mucosal melanoma.

The company recently initiated enrollment in ARTISTRY-6, a global phase 2 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.

Alkermes has been the subject to notable activists’ activity over the past year: in December of 2020 the company announced a Strategic Value Enhancement Plan and a continuous board refreshment, after reaching a deal with Elliott Advisors. This was followed by an agreement with Sarissa Capital, earlier this year.

Shares of ALKS are moving nearly 3% higher on the announcement, reaching a 2-year high of $26.61.

Written by Vlad Schepkov | [email protected]