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Hemogenyx Pharmaceuticals Says U.S. FDA Defers Pre-IND Meeting Until May

By Anthony O. Goriainoff

 

Hemogenyx Pharmaceuticals PLC said Wednesday that the U.S. Food and Drug Administration has deferred a proposed pre-investigational-new-drug, or pre-IND, meeting until May as it is prioritizing work on Covid-19.

The London-listed biopharmaceutical group said the deferment wasn't caused by any delay in the development of its lead product candidate, Chimeric Antigen Receptor T-cells, known as HEMO-CAR-T.

The company--which develops new therapies and treatments for blood diseases--said that in the meantime HEMO-CAR-T's process will be dealt with via written responses by the FDA to a submission the company was in the process of refining. The company said a pre-IND meeting will only be necessary if the written responses leave any matters unresolved.

"The process toward our IND application remains on track and the change in the FDA's process is not expected to affect the outcome of the IND application or timetable for clinical trials," Chief Executive Vladislav Sandler said.

Shares at 0801 GMT were down 0.05 pence, or 3%, at 1.63 pence.

 

Write to Anthony O. Goriainoff at anthony.orunagoriainoff@dowjones.com

 

(END) Dow Jones Newswires

February 16, 2022 03:27 ET (08:27 GMT)

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