Hemogenyx Pharmaceuticals PLC - London-based biopharmaceutical company focused on treatments for deadly blood diseases - US Food & Drug Administration has lifted clinical hold on company’s investigational new drug application for Hemo-Car-T to treat acute myeloid leukemia. FDA placed therapy on clinical hold in July due to a splicing deficiency during manufacture of the lentivirus used to produce Car-T cells. Hemogenyx in August produced a ‘detailed plan, supported by laboratory tests’ to address FDA’s concerns, which was accepted the following month.
Company says on Friday that the FDA has confirmed that all issues identified in its clinical hold letter have been satisfactorily addressed. FDA therefore consents to Hemogenyx proceeding with its phase 1 clinical study of Hemo-Car-T.
Chief Executive Officer Vladislav Sandler comments: ‘We are extremely pleased with the FDA’s decision to lift the clinical hold. We now look forward to accelerating clinical development of Hemo-Car-T and to offering patients a potentially life-saving treatment.’
Current stock price: 4.41 pence, up 13% on Friday morning
12-month change: up 90%
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