07:04 AM EDT, 09/10/2025 (MT Newswires) -- Greenwich LifeSciences ( GLSI ) said Wednesday the US Food and Drug Administration granted fast track designation for its GLSI-100 breast cancer treatment for HLA-A*02 patients.

The company is evaluating GLSI-100 for the prevention of breast cancer recurrences in a phase III clinical trial.

Greenwich LifeSciences ( GLSI ) intends to continue discussions with the FDA, and potentially regulatory authorities in Europe, to explore more ways to make GP2 and GLSI-100 available to larger populations, Chief Executive Snehal Patel said.

The fast track process helps facilitate the development, and expedite the review, of drugs to treat serious conditions and fill an unmet medical need.

Greenwich LifeSciences ( GLSI ) shares were up nearly 19% in recent premarket activity.