IN BRIEF: Hemogenyx submits FDA application for Hemo-Car-T treatment

Hemogenyx Pharmaceuticals PLC - London-based biopharmaceutical group developing new therapies and ...

Alliance News 9 May, 2023 | 2:16PM
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Hemogenyx Pharmaceuticals PLC - London-based biopharmaceutical group developing new therapies and treatments for deadly blood diseases - Submits investigational new drug application seeking authorisation from the US Food & Drug Administration to begin a phase 1 clinical trial of its lead product chemic antigen receptor T-cells, or Hemo-Car-T, for treating acute myeloid leukemia.

Says the application follows "successful work on manufacturability, quality, safety and other key parts" of developing Hemo-Car-T. Says it plans to initiate a phase 1 clinical trial of Hemo-Car-T, once the clinical investigation plan proposed in the IND submission has been cleared to proceed by the FDA.

Co-Founder & Chief Executive Officer Vladislav Sandler says: "We are pleased to have reached this milestone with Hemo-Car-T. We are committed to advancing therapies for blood diseases, and our work to address [acute myeloid leukemia], which currently has poor survival rates, is an essential part of that commitment."

Current stock price: 2.10 pence, up 4.0%

12-month change: up 54%

By Greg Rosenvinge, Alliance News reporter

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Security Name Price Change (%) Morningstar
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Hemogenyx Pharmaceuticals PLC 1.56 GBX -2.19 -

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