By Chris Wack
Homology Medicines Inc. shares were down 27% to $2.82 Tuesday after it said the U.S. Food and Drug Administration notified the company that its pheNIX gene therapy trial of HMI-102 in adults with phenylketonuria has been placed on clinical hold due to the need to modify risk mitigation measures in the study in response to observations of elevated liver function tests.
On Friday, the genetics medicine company said it expects to receive an official clinical hold letter within 30 days.
Homology plans to provide an update pending further clarity from the FDA.
"This hold on our PKU gene therapy trial is based on clinical observations in the pheNIX study and does not relate to CMC/manufacturing capabilities or Homology's other clinical programs," said Arthur Tzianabos, president and chief executive of Homology Medicines. "We plan to provide next steps once we have more information following our FDA interactions."
Homology has two ongoing clinical programs, the pheEDIT gene editing trial of HMI-103 for PKU and the juMPStart gene therapy trial of HMI-203 for Hunter syndrome, with program updates expected by the end of this year.
Oppenheimer changed its recommendation for Homology stock to perform from market perform. RBC Capital moved its stance to sector perform from outperform, and cut its price target to $4 a share from $30. BTIG cut its price target to $29 from $35 a share, and Chardin Capital cut its price target to $15 from $25 a share.
Write to Chris Wack at firstname.lastname@example.org
(END) Dow Jones Newswires
February 22, 2022 10:24 ET (15:24 GMT)Copyright (c) 2022 Dow Jones & Company, Inc.