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Homology Medicines, Inc.

The law firm of Kirby McInerney LLP announces that a class action lawsuit has been filed in the U.S. District Court for the Central District of California on behalf of those who acquired Homology Medicines, Inc. (“Homology” or the “Company”) (NASDAQ: FIXX) securities from June 10, 2019 through February 18, 2022 (the “Class Period”). Investors have until May 24, 2022 to apply to the Court to be appointed as lead plaintiff in the lawsuit.
Homology is a genetic medicines company that focuses on transforming the lives of patients suffering from rare genetic diseases. The Company’s lead product candidate is HMI-102, which is in Phase I/II pheNIX clinical trial, a gene therapy for the treatment of phenylketonuria (PKU) in adults (the “HMI-102 Trial”).
On July 21, 2020, Mariner Research (“Mariner”) published a report questioning statements by Homology and its officers about the efficacy of HMI-102, the Company’s lead product candidate for treatment of phenylketonuria. Mariner focused on Homology’s HMI-102 dose escalation pheNIX trial, concluding that the Company concealed data showing HMI-102’s lack of efficacy and indicating that the program was unlikely to proceed to commercialization. Among other evidence, Mariner cited an email from Homology’s Chief Communications Officer appearing to indicate the Company’s awareness that a HMI-102 high dose patient had adverted to the adverse efficacy issue in a social media post during April 2020. On this news, Homology’s stock price declined by $0.44 per share, or approximately 2.67%, from $16.48 per share on July 21, 2020 to close at $16.04 per share on July 22, 2020.
Then, on February 18, 2022, Homology issued a press release disclosing 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” and that “[t]he Company expects to receive an official clinical hold letter within 30 days.” On this news, Homology’s stock price declined by $1.26 per share, or approximately 32.64%, from $3.86 per share on February 18, 2022 to close at $2.60 per share on February 22, 2022.
The lawsuit alleges throughout the Class Period, Defendants made false and misleading statements and failed to disclose that: (i) the Company had overstated HMI-102’s efficacy and risk mitigation; (ii) accordingly, it was unlikely that the Company would be able to commercialize HMI-102 in its present form; and (iii) as a result, the Company’s public statements were materially false and misleading at all relevant times.

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