Nasdaq

Greenwich LifeSciences’ GLSI-100 Granted US FDA Fast Track Designation

STAFFORD, Texas, Sept. 10, 2025 (GLOBE NEWSWIRE) -- Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, ...
Seeking Alpha

Greenwich LifeSciences soars on FDA Fast Track status for lead asset

Greenwich LifeSciences (NASDAQ:GLSI) added ~32% in the premarket on Wednesday after the U.S. FDA issued its Fast Track designation for its lead asset GLSI-100 to treat a subset of breast cancer ...
Nasdaq

Greenwich LifeSciences Gets Fast Track Designation For GLSI-100

(RTTNews) - Greenwich LifeSciences, Inc. (GLSI) Wednesday said that it has received Fast Track Designation for GLSI-100 in the HLA-A*02 population of breast cancer patients. Key benefits of Fast Track ...
Cure Today

FDA Fast Tracks Vaccine For Some With Breast Cancer

GLSI-100 has received FDA fast track designation for HLA-A*02-positive and HER2-positive breast cancer, expediting its development and review process. Preliminary data from the FLAMINGO-01 trial shows ...
Hosted on MSN

Greenwich LifeSciences granted Fast Track designation for GLSI-100 by FDA

Greenwich LifeSciences (GLSI) announced that FDA has granted Fast Track designation for GLSI-100 in the HLA-A*02 patient population. The designation specifically states that “GLSI-100 for the ...