Hemogenyx Share News (HEMO)

Hemogenyx says Hemo-Car-T treatment placed on clinical hold by US FDA

(Alliance News) - Hemogenyx Pharmaceuticals PLC on Monday said it has received a review letter from the US Food & Drug Administration confirming its placement of Hemo-Car-T on clinical hold.

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IN BRIEF: Hemogenyx announces clinical hold for Hemo-Car-T treatment

Hemogenyx Pharmaceuticals PLC -hemo London-based biopharmaceutical group developing new therapies and treatments for deadly blood diseases - Notes receipt of notice from the US Food & Drug Administration over its investigational new drug application for its product candidate Chimeric Antigen Receptor T-cells, or Hemo-Car-T. Says Hemo-Car-T is a treatment for acute myeloid leukemia. Says FDA put Hemo-Car-T on clinical hold, pending an FDA letter to be received within 30 days detailing what additional information needs to be provided by Hemogenyx. Hemogenyx submitted the investigational new drug application in early May, seeking authorisation to begin a phase 1 clinical trial of Hemo-Car-T.

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

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.

EARNINGS SUMMARY: DP Aircraft profit swing, Chesterfield loss widens

(Alliance News) - The following is a round-up of earnings updates by London-listed companies, issued on Friday and not separately reported by Alliance News:

TRADING UPDATES: Fragrant Prosperity to buy Hi 55, Oscillate talks end

(Alliance News) - The following is a round-up of updates by London-listed companies, issued on Thursday not separately reported by Alliance News:

Hemogenyx raises GBP4 million in share placing for Hemo-CAR-T product

(Alliance News) - Hemogenyx Pharmaceuticals PLC on Thursday said it successfully raised GBP4.1 million in a placing of new shares, with the fresh cash to be used to progress its Hemo-CAR-T product candidate into clinical trials.

IN BRIEF: Hemogenyx completes process run for HEMO-CAR-T manufacture

Hemogenyx Pharmaceuticals PLC - London-based biopharmaceutical group developing new therapies and treatments for deadly blood diseases - Completes third process qualification run for the manufacture of HEMO-CAR-T cells. Says the HEMO-CAR-T cells will be tested by third party to ensure quality. The three process runs are required by the US Food & Drug Administration to begin clinical trials. Following completion of all tests across all PQ runs, data will be compiled for inclusion in the investigational new drug submission pack. HEMO-CAR-T cells are being developed the potential treatment of acute myeloid leukemia, a blood and bone marrow cancer.

Hemogenyx shares up on single target protein virus treatment finding

(Alliance News) - Hemogenyx Pharmaceuticals PLC shares jumped early Monday, after the company announced the discovery of a single target protein for use against multiple dangerous viruses.

IN BRIEF: Hemogenyx Pharma second process qualification run successful

Hemogenyx Pharmaceuticals PLC - London-based biotechnology company - Successfully completes its second process qualification run of the end-to-end process for the manufacture of HEMO-CAR-T cells. The company says it was followed by analytical release tests to verify the quality of the manufactured cells. The run is the second of three identical manufacturing runs required by the US Food and Drug Administration for the submission of an investigational new drug application. The IND application is needed in order to commence phase one clinical trials of HEMO-CAR-T cells.

SMALL-CAP WINNERS & LOSERS: HeiQ drops on expectation of lower sales

(Alliance News) - The following stocks are the leading risers and fallers among London Main Market small-caps on Wednesday.

Hemogenyx makes final development run of HEMO-CAR-T cell manufacture

(Alliance News) - Hemogenyx Pharmaceuticals PLC on Friday said it has completed the final development run for its manufacturing process of HEMO-CAR-T cells.

EARNINGS UPDATES: Hemogenyx hopes on cancer drug; IDE loss widens

(Alliance News) - The following is a round-up of updates by London-listed companies, issued on Thursday and not separately reported by Alliance News:

Hemogenyx wins patent for bi-specific antibody method in China

(Alliance News) - Hemogenyx Pharmaceuticals PLC on Monday said it has been awarded a patent for its bi-specific antibody in China.

Hemogenyx Pharmaceuticals names Koen van Besien as medical director

(Alliance News) - Hemogenyx Pharmaceuticals PLC on Wednesday named Koen van Besien as its new medical director.