By Elena Vardon

Hemogenyx Pharmaceuticals shares rose on Monday after the company said it is remanufacturing the lentivirus used in its acute myeloid leukemia treatment product candidate after the U.S. Food and Drug Administration raised concerns about it.

At 0729 GMT, shares were up 0.17 pence, or 11%, at 1.63 pence.

The FDA concerns were related to splicing that occurs during the manufacturing of the lentivirus, the company said.

The biopharmaceutical group--that develops new therapies and treatments for blood diseases--said it identified the source of the splicing deficiency and has developed a method to eliminate it after the regulator explained in a letter its rationale behind placing the application on clinical hold.

The group said the FDA also shared suggestions on how to improve the safety of the treatment, adding they don't relate to the clinical hold and can be dealt with quickly.

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

(END) Dow Jones Newswires

July 10, 2023 04:00 ET (08:00 GMT)

Copyright (c) 2023 Dow Jones & Company, Inc.
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