Elevation Oncology Shares Rise 18% After Fast Track Designation for Seribantumab

By Chris Wack

Elevation Oncology Inc. shares were up 18% to $4.15 Wednesday after the biopharmaceutical company said the U.S. Food and Drug Administration granted fast track designation to seribantumab to treat tumors.

The stock, which hit its 52-week low of $2.28 on April 22, closed Tuesday's session up 11%.

Seribantumab for the tumor-agnostic treatment of advanced solid tumors that harbor neuregulin-1 gene fusions is being evaluated in a Phase 2 study. The initial data from the study will be presented in June, the company said.

"There are currently no approved therapies that specifically target NRG1 fusions, and therefore, receipt of fast track designation in a tumor-agnostic setting is a significant step in addressing this unmet need," Chief Executive Shawn Leland said.

Fast track is an FDA process designed to facilitate the development and expedite the review of potential therapies that seek to treat serious conditions and fill an unmet medical need. A drug candidate that receives fast track designation is afforded greater access to the FDA for the purpose of expediting the drug's development, review and potential approval.

Write to Chris Wack at chris.wack@wsj.com

(END) Dow Jones Newswires

May 25, 2022 10:39 ET (14:39 GMT)

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