(Alliance News) - Hemogenyx Pharmaceuticals PLC on Tuesday said it submitted a complete response to the previously announced clinical hold of the investigational new drug application to the US Food & Drug Administration.
The London-based biopharmaceutical company focused on treatments for deadly blood diseases said the submission was for HEMO-CAR-T, an immunotherapy for the potential treatment of acute myeloid leukaemia, a cancer of the white blood cells. "Acute" means it progresses quickly and aggressively.
A complete response is a requirement for the clinical hold to be lifted, needed to obtain consent from the FDA to start phase 1 clinical trials.
Chief Executive Officer Vladislav Sandler said: "We are pleased to have filed a complete response to the FDA addressing their concerns that resulted in a CH of the HEMO-CAR-T IND. We look forward to becoming a clinical stage biopharmaceutical company once consent is received from the FDA."
Hemogenyx shares rose 3.3% to 2.27 pence each on Tuesday morning in London.
By Tom Budszus, Alliance News slot editor
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Hemogenyx (HEMO)