GLSI - Greenwich stock rises 14% as FDA lifts hold on phase 3 breast cancer trial
- Greenwich LifeSciences ( NASDAQ: GLSI ) said the U.S. Food and Drug Administration (FDA) removed a clinical hold on a phase 3 trial in breast cancer allowing it to progress.
- The trial, dubbed Flamingo-01 , will evaluate a combination of immunotherapy GP2 + GM-CSF, together called GLSI-100, to treat patients with breast cancer having mutation in the HLA gene.
- Greenwich said the the trial was placed on hold by the FDA due to manufacturing and pharmacy process.
- The company added that via discussions with the FDA and testing of GP2 in the pharmacy process it satisfactorily addressed the hold issues and committed to additional testing of GP2 in the pharmacy process.
- Greenwich noted that it has begun site initiation visits and will provide updates on the study in the future.
- GLSI +14.04% to $9.83 premarket July 12.
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Greenwich stock rises 14% as FDA lifts hold on phase 3 breast cancer trial