Homology Medicines (FIXX) Stock: Why Its Trending Today

By Amit Chowdhry ● Feb 22, 2022
  • The Homology Medicines Inc (NASDAQ: FIXX) stock is trending today. This is why.

The Homology Medicines Inc (NASDAQ: FIXX) stock is trending today. Homology Medicines announced today that the U.S. Food and Drug Administration (FDA) has notified the company that its pheNIX gene therapy trial of HMI-102 in adults with phenylketonuria (PKU) 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.

The company expects to receive an official clinical hold letter within 30 days. Homology plans to provide an update pending further clarity from the FDA.

Homology has 2 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.

The company stock price fell by over 25% during intraday trading today following the news.

KEY QUOTE:

“We look forward to working with the FDA to address the Agency’s questions and feedback once we receive the letter. 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. We plan to provide next steps once we have more information following our FDA interactions.”

— Arthur Tzianabos, Ph.D., President and Chief Executive Officer of Homology Medicines

Disclaimer: This content is intended for informational purposes. Before making any investment, you should do your own analysis.