FIXX - Homology Medicines sinks on FDA clinical hold for phenylketonuria trial

Homology Medicines (NASDAQ:FIXX) has lost ~35% in the post-market Friday after the genetic medicines company announced that the U.S. Food and Drug Administration (FDA) imposed a clinical hold on its pheNIX gene therapy trial of HMI-102 in adults with phenylketonuria (PKU). The need to modify the trial's risk mitigation measures in response to elevated liver function tests in patients has prompted the federal agency to pause the trial, according to the company. An official clinical hold letter from the FDA is expected within 30 days. Homology (FIXX) plans to issue further updates following further clarity from the agency. “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,” Chief Executive Officer Arthur Tzianabos remarked. He added that the company would cooperate with the FDA to resolve the issues, following the receipt of the official

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Homology Medicines sinks on FDA clinical hold for phenylketonuria trial