Hemogenyx Pharmaceuticals Shares Fall After FDA Puts Leukemia Treatment Application on Hold

By Elena Vardon

Hemogenyx Pharmaceuticals shares slumped 28% on Friday after the company said its application for its acute myeloid leukemia treatment product candidate was put on clinical hold by the U.S. Food and Drug Administration pending more information.

At 1034 GMT, shares were down 0.65 pence at 1.65 pence.

The biopharmaceutical group--that develops new therapies and treatments for blood diseases--said its Investigational new drug (IND) application for its chimeric antigen receptor t-cells is on hold pending the receipt of a letter from the FDA.

The letter will set out additional information the FDA requires from the company and is expected to be received within 30 days, it said.

"We are confident that we will be able to address the FDA's questions and concerns regarding the IND. [Acute myeloid leukemia] has poor survival rates and we are eager to resolve this hold and continue down the treatment development pathway toward saving lives," Chief Executive Vladislav Sandler said.

Write to Elena Vardon at elena.vardon@wsj.com

(END) Dow Jones Newswires

June 02, 2023 06:59 ET (10:59 GMT)

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