Greenwich LifeSciences Inc. announced that the U.S. Food and Drug Administration (FDA) has approved the use of the first commercially manufactured lot of GP2 in the company's Phase III clinical trial, FLAMINGO-01. The trial is evaluating GLSI-100, an immunotherapy aimed at preventing breast cancer recurrences. The approved GP2 vials will be used at all 40 U.S. clinical sites participating in the study. The company plans to submit additional manufacturing data as part of its preparations to file a Biological License Application (BLA) in the U.S. under Fast Track Designation, and to regulatory agencies in Europe, the United Kingdom, and Canada.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Greenwich Lifesciences Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9630254-en) on January 22, 2026, and is solely responsible for the information contained therein.