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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, FLAMINGO-01, which is evaluating GLSI-100, an immunotherapy to prevent breast cancer recurrences, today 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 treatment of patients with HLA-A*02 g
About this update from Greenwich Lifesciences, Inc.
[{"type":"image","alt":"Greenwich LifeSciences, Inc.","displaySize":"","headline":null,"caption":"Greenwich LifeSciences, Inc.","className":"","disableSlideshowImg":false,"size":{"original":{"width":300,"height":123,"url":"https://media.zenfs.com/en/globenewswire.com/5236cbdf62d9160f7f17a269e6a93fa7"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/CdB3UijgWjtUF2S9KALplg--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTE3MjtjZj13ZWJw/https://media.zenfs.com/en/globenewswire.com/5236cbdf62d9160f7f17a269e6a93fa7","width":300,"height":123}},"lazy":false},{"type":"text","content":"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, FLAMINGO-01, which is evaluating GLSI-100, an immunotherapy to prevent breast cancer recurrences, today announced that FDA has granted Fast Track designation for GLSI-100 in the HLA-A*02 patient population.","length":413,"tagName":"p"},{"type":"text","content":"The designation specifically states that "GLSI-100 for the treatment of patients with HLA-A*02 genotype and HER2-positive breast cancer who have completed treatment with standard of care HER2/neu targeted therapy to improve invasive breast cancer free survival meets the criteria for Fast Track designation."","length":318,"tagName":"p"},{"type":"text","content":"The Fast Track designation for GLSI-100 may lead to earlier drug approval as the Company and the FDA can communicate more frequently to expedite the Biologic License Application (BLA) filing of the clinical and manufacturing data from FLAMINGO-01. The Company may be able to utilize a rolling review process, where completed parts of the BLA can be submitted for review, even though other parts of the application are still being completed.","length":440,"tagName":"p"},{"type":"text","content":"Dr. Jaye Thompson, VP Clinical and Regulatory Affairs, commented, "Greenwich is pleased that the FDA sees the potential of GLSI-100 to change important clinical outcomes in this population of breast cancer patients. We continue to work earnestly to collect data to support a BLA filing demonstrating this benefit."","length":324,"tagName":"p"},{"type":"text","content":"CEO Snehal Patel commented, "We are excited to have received Fast Track designation. The FDA revie...