Evaxion Biotech Shares Rally Premarket on FDA Fast-Track Designation

By Colin Kellaher

Shares of Evaxion Biotech AS jumped more than 20% in premarket trading Thursday after the clinical-stage biotechnology company said the U.S. Food and Drug Administration granted fast-track designation to its EVX-01 personalized cancer therapy in combination with Merck & Co.'s blockbuster cancer drug Keytruda.

Copenhagen-based Evaxion last month received FDA approval to proceed with a Phase 2b study of EVX-01, its most advanced clinical asset, in combination with Keytruda in patients with the skin cancer metastatic melanoma.

The FDA's fast-track program is designed to facilitate the development and expedite the review of treatments for serious or potentially life-threatening illnesses with high unmet medical needs.

Evaxion shares, which closed Wednesday at $1.60, were recently up nearly 21%, to $1.93, in premarket trading.

Write to Colin Kellaher at [e-mail]

(END) Dow Jones Newswires

01-19-23 0912ET