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.