FDA places Homology's pheNIX gene therapy trial for PKU on clinical hold due to elevated liver tests

Q32 Bio Inc.

FDA notified Homology on Feb 16, 2022 that HMI-102 trial is on clinical hold to modify risk mitigation for elevated liver function tests.
Company expects official clinical hold letter within 30 days and will provide update after FDA interactions.
Clinical hold does not affect CMC/manufacturing or other programs (HMI-103 gene editing, HMI-203 for Hunter syndrome).
Homology expects program updates for HMI-103 and HMI-203 by end of 2022.

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