Elevation Oncology, Inc. ELEV received Fast Track designation from the Food and Drug Administration (FDA) for Seribantumab in tumor-agnostic settings for the treatment of advanced solid tumors that harbor NRG1 gene fusions.
Seribantumab is being investigated in the ongoing Phase 2 CRESTONE study for patients with solid tumors harboring NRG1 gene fusions.
"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," said Shawn M. Leland, PharmD, RPh, founder and chief executive officer. "We look forward to working closely with the FDA as we continue exploring the potential of seribantumab to improve outcomes for patients whose tumor harbors this unique oncogenic driver."
The company plans to present initial data from the Phase 2 study in an oral presentation at the upcoming American Society of Clinical Oncology (ASCO) 2022 Annual Meeting on June 7, 2022.
Fast Track Designation is intended to expedite the development and review of new drugs to treat serious medical conditions that fill unmet medical needs.
Price Check: Shares of Elevation Oncology are trading 24.1% higher at $4.37 in Wednesday's premarket session, according to Benzinga Pro.
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