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(Alliance News) - Hemogenyx Pharmaceuticals PLC on Monday said it completed a process qualification run.
The London-based biopharmaceutical company focused on treatments for deadly blood diseases said it successfully completed its process qualification run for the manufacture of HEMO-CAR-T cells.
It added that the process qualification run is the only manufacturing run required for the submission of a complete response to the clinical hold of the investigational new drug application to the US Food & Drug Administration for HEMO-CAR-T.
Chief Executive Officer Vladislav Sandler said: "We are pleased that we have now completed the necessary PQ run. We are now working hard to resubmit the IND as expeditiously as possible to move forward with clinical trials of HEMO-CAR-T."
Hemogenyx shares fell 8.7% to 2.10 pence each on Monday morning in London.
By Tom Budszus, Alliance News slot editor
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