Greenwich LifeSciences (NASDAQ:GLSI) shares jumped Thursday morning after the clinical-stage biotech announced that the U.S. Food and Drug Administration (FDA) has approved the use of its first commercially manufactured lot of GP2 vials in the ongoing FLAMINGO-01 Phase III trial.
The decision marks a critical operational pivot, as the company prepares to transition from clinical-scale to commercial-grade drug supply for its lead immunotherapy, GLSI-100.
The Texas-based company confirmed it has produced three commercial lots of active ingredient—sufficient for approximately 200,000 doses—alongside a finished vial lot filled in 2024.
Robust stability programs have already yielded three years of data, which management expects will support a commercial expiration date upon potential market entry.
"With the FDA's approval to use these finished commercial vials in FLAMINGO-01, we have taken a major step to further de-risk the filing of a Biologics License Application (BLA)," said CEO Snehal Patel.
GLSI-100 is designed to prevent breast cancer recurrence in patients who have already undergone surgery and standard-of-care HER2-targeted therapy.
The FLAMINGO-01 trial is currently expanding to up to 150 sites globally, with the newly approved commercial vials set to be deployed across 40 U.S. sites in the coming weeks.
By integrating commercial manufacturing data into the Phase III study, Greenwich aims to satisfy the stringent CMC (Chemistry, Manufacturing, and Controls) requirements needed for its upcoming Fast Track BLA submission.