By Josh Beckerman
Homology Medicines Inc. shares were down 38% after hours at $2.39 after the genetic medicines company reported a clinical hold.
The company said the U.S. Food and Drug Administration notified the company that its pheNIX gene therapy trial of HMI-102 in adults with phenylketonuria was placed on clinical hold "due to the need to modify risk mitigation measures" in response to "observations of elevated liver function tests."
Homology Medicines expects to receive an official clinical hold letter within 30 days.
The company said, "we look forward to working with the FDA to address the Agency's questions and feedback." It added that the hold "does not relate to CMC/manufacturing capabilities or Homology's other clinical programs."
Write to Josh Beckerman at firstname.lastname@example.org
(END) Dow Jones Newswires
February 18, 2022 19:07 ET (00:07 GMT)Copyright (c) 2022 Dow Jones & Company, Inc.