ALX Oncology Shares Gain As FDA Grants Fast Track Status To Head And Neck Cancer Candidate

ALX Oncology Holdings (NASDAQ: ALXO) receives Fast Track designation from the U.S. Food and Drug Administration (FDA) for its lead asset Evorpacept in combination with KEYTRUDA (pembrolizumab) for the first-line treatment of adult patients with PD-L1 positive advanced head and neck squamous cell carcinoma (HNSCC).

The regulatory grant is supported by the results of its ASPEN-01, ASPEN-02 and ASPEN-03 clinical studies evaluating evorpacept and pembrolizumab combination in patients with second-line or greater advanced HNSCC.

Sophia Randolph, Chief Medical Officer, said, “The FDA's Fast Track designation for the first-line treatment of HNSCC with evorpacept in combination with pembrolizumab builds upon evorpacept's prior Fast Track designation in the first-line HNSCC population in combination with pembrolizumab and standard chemotherapy highlighting the potential clinical utility of evorpacept in this difficult-to-treat disease.”

The company is enrolling patients across its HNSCC phase 2 program to advance evorpacept to help patients living with this disease.

FDA 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 Action : ALX Oncology shares are trading around 5 percent at $10.19 on Monday during pre-market session.