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DewDiligence

02/18/22 6:55 PM

#241556 RE: DewDiligence #227786

FIXX -38%/AH on FDA clinical hold:

https://www.globenewswire.com/news-release/2022/02/18/2388173/0/en/Homology-Medicines-Provides-an-Update-on-pheNIX-Gene-Therapy-Trial-for-Adults-with-PKU.html

Homology Medicines, Inc…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.

FIXX is down 85% from its 2018 IPO price (#msg-139606493).