Why Did Greenwich LifeSciences Soar 22.49%? Positive FLAMINGO-01 Data
1min read Greenwich LifeSciences, Inc. (GLSI) has seen a significant surge in its stock price, rising 22.49% in pre-market trading on April 4, 2025. This substantial increase reflects the market's positive response to recent developments and announcements from the company.
Greenwich LifeSciences has reported encouraging preliminary immune response data from its FLAMINGO-01 Phase III study. This data suggests that GP2 is a natural antigen that may have played a role in the immune response of patients during prior treatments with trastuzumab or other therapies. The positive results from this trial have been a key driver of investor optimism.
The company has also expanded the non-HLA-A*02 arm of the FLAMINGO-01 trial to 250 patients, with approval from both EU and US regulators. This expansion is part of a broader strategy to enhance the trial's scope and potential market reach. The company is considering further changes to the trial, including the possibility of transforming the non-HLA-A*02 open label third arm into a second Phase III trial, which could lead to multiple pathways for marketing approval of GLSI-100 and a larger market potential.
In addition to the trial expansions, Greenwich LifeSciences has achieved its highest screening rate to date, with over 150 patients screened per quarter. This screening rate is equivalent to 600 patients per year across 117 active sites in the US and EU. The company plans to activate 30 additional sites in the EU in 2025, with the potential for another 10 sites to be approved and added in additional EU countries, bringing the total potential sites to over 150 globally.
