Hemogenyx Pharmaceuticals plc develops clinical-stage biopharmaceutical therapies for blood and autoimmune diseases. Company news centers on HG-CT-1, its CAR-T cell therapy program for relapsed or refractory acute myeloid leukemia, including FDA IND reporting, clinical development updates, product stability work and lentiviral-vector manufacturing processes.
Recurring announcements also cover the company's CDX and CBR product candidates, platform technologies used for novel product development, and capital-market actions such as equity issuance, warrant exercises, prospectus publication, total voting rights and admissions of ordinary shares to trading on the London Stock Exchange.
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Hemogenyx Pharmaceuticals has announced the successful completion of analytical tests for its HEMO-CAR-T production across three Process Qualification (PQ) runs. These PQ runs, conducted in cGMP compliant facilities, are crucial for ensuring the quality of the manufactured cells, focusing on attributes like viability, potency, and sterility. This achievement fulfills the last manufacturing requirement for submitting an Investigational New Drug (IND) application to the FDA, which is currently being prepared. The IND is necessary to initiate Phase I clinical trials for HEMO-CAR-T, marking a significant step forward in the Company's development of new therapies for blood diseases.
Hemogenyx Pharmaceuticals announced total voting rights as of February 28, 2023, confirming the issuance of 1,141,999,321 ordinary shares with a nominal value of 1 pence each. The company holds no treasury shares, resulting in the same number of voting rights available to shareholders. This figure is crucial for shareholders to determine their reporting obligations concerning changes in their shareholdings under the Financial Conduct Authority's Disclosure Guidance and Transparency Rules.