Story
Greenwich LifeSciences Shares Climb on EMA Approval for Breast Cancer Immunotherapy Trial
Shares of Greenwich LifeSciences, Inc. (NASDAQ:GLSI) rose 7.7% on Thursday following the company's announcement that it received a key regulatory approval from the European Medicines Agency (EMA). The clearance allows the use of its commercially manufactured GP2 immunotherapy in the European arm of its FLAMINGO-01 Phase III clinical trial.
Key Regulatory Milestone
The EMA's decision is a significant step for the ongoing trial, which is evaluating GLSI-100 as a preventative treatment for breast cancer recurrences. This approval ensures that all clinical sites, both in the U.S. and Europe, can use the same standardized, commercially produced lot of GP2, simplifying trial logistics and data consistency.
This follows a similar clearance from the U.S. Food and Drug Administration (FDA) in early 2026 for the same commercial batch. According to Greenwich LifeSciences, all of its approximately 40-50 U.S. sites have already begun treating patients with these vials. The company is now pursuing separate regulatory approvals to use the lot in the UK and Canada.
Trial Progress and Early Data
AdThe FLAMINGO-01 trial continues to expand, with the number of clinical sites growing from 160 to an estimated 170-180. The company also reported strong patient enrollment metrics:
- More than 1,300 patients have been screened to date.
- The current screening rate is approximately 800 patients per year.
- The 250-patient non-HLA-A02 arm of the study is now fully enrolled.
A preliminary analysis of this fully enrolled group after their initial immunization series showed an approximate 70-80% reduction in the recurrence rate. The company noted this trend is consistent with the results from its earlier Phase IIb trial, which demonstrated an up to 80% reduction in recurrences in a different patient population.