Announcement
On 9 July 2026, Greenwich LifeSciences, Inc. (NASDAQ:GLSI) reported that the European Medicines Agency (EMA) cleared the commercially manufactured GP2 lot for use in its FLAMINGO‑01 Phase III clinical trial. The news prompted the company’s shares to rise 7.7% on the trading day.
Clinical Trial Update
The EMA clearance permits all clinical sites in the United States and Europe to employ the same GP2 lot in the Phase III trial evaluating GLSI‑100, an immunotherapy intended to prevent breast‑cancer recurrences. Clinical sites have expanded from 160 to approximately 170‑180, and shipments of the GP2 lot to European pharmacies are already underway. To date, the FLAMINGO‑01 trial has screened more than 1,300 patients, with a current enrollment screen rate of roughly 800 patients per year. The 250‑patient non‑HLA‑A02 arm is now fully enrolled, representing five‑fold the number of patients treated in the earlier Phase IIb trial (approximately 50 patients). A preliminary analysis of recurrence rates in the non‑HLA‑A02 arm after the Primary Immunization Series indicates an estimated 70‑80% reduction in recurrence, mirroring Phase IIb results where recurrences were reduced up to 80% in HLA‑A02 patients.
Manufacturing and Regulatory Milestones
The first three commercial lots of the GP2 active ingredient were produced in 2023 at an approved commercial facility, together capable of preparing about 200,000 doses. The inaugural commercial lot that filled GP2 into vials was manufactured in 2024. Earlier, the U.S. Food and Drug Administration (FDA) approved the first commercial GP2 lot in early 2026, and approximately 40‑50 U.S. sites have begun treating patients with these vials. Greenwich LifeSciences is now pursuing separate regulatory approvals to use the same lot in the United Kingdom and Canada.
Market Impact
The EMA approval and the associated trial progress drove a 7.7% increase in Greenwich LifeSciences’ share price, reflecting investor optimism about the commercial potential of the GP2‑based immunotherapy.