GREENWICH LIFESC. DL-,001

Shares of Greenwich LifeSciences rose 6.4% in premarket trading to $16.29, driven by positive clinical, regulatory and financial developments. In Q2 the company lost $0.27 per share, a slight improvement versus the prior year, but it has not yet generated any revenue. The phase III FLAMINGO-01 study has enrolled more than 1,500 patients at around 170–180 sites; the open arm with 250 non-HLA-A02 patients is fully recruited, and preliminary analyses suggest a 70–80% reduction in breast cancer recurrence rates. Additional catalysts included approvals to expand the study in the U.K. and to pool HLA populations in Europe, an increased price target from HC Wainwright and several insider purchases. » Plus sur de.investing.com

Greenwich LifeSciences’ stock rose 5.4% pre-market after a detailed update on the Phase‑III FLAMINGO‑01 trial explaining the scientific and statistical basis for the previously communicated protocol changes. The independent DSMB had recommended in May 2026 to continue the trial unchanged, and the company stresses that adjusting the hazard ratio and doubling the number of events required for the first interim analysis would significantly increase the chance of success for that interim look if the treatment effect matches the Phase‑IIb results. Additional support comes from EMA approval to combine both HLA patient populations, effectively more than doubling recruitment for the approval‑relevant arm. » Plus sur de.investing.com

The European Medicines Agency has allowed Greenwich LifeSciences to include HLA‑A02 and non‑HLA‑A02 patients in the phase‑III trial FLAMINGO‑01, so all US and EU sites will now operate under the same protocol. The non‑HLA‑A02 arm of 250 patients is already fully enrolled; more than 1,300 patients have been screened in total, with a current screening rate of about 800 per year. A preliminary analysis shows a reduction in the recurrence rate of roughly 70–80% in the non‑HLA‑A02 arm after the primary immunization series, confirming the positive trend seen in the phase‑IIb trial. The development has attracted investor interest; however, the company remains unprofitable, as is typical for clinical biotech firms. » Plus sur de.investing.com