Homology, a genetic medicines company, 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 June 10, 2019, Homology issued a press release announcing that it had commenced enrollment of the HMI-102 Trial. The complaint alleges that throughout the Class Period, Defendants made materially false and misleading statements regarding the Company’s business, operations, and compliance policies. Specifically, Defendants made false and/or misleading statements and/or 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. 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 fell $1.71 per share, or 10.38%, over the following three trading days, closing at $14.77 per share on July 24, 2020. Then, on February 18, 2022, Homology issued a press release disclosing that “the U.S. Food and Drug Administration has notified the company that its pheNIX gene therapy trial of HMI-102 in adults with phenylketonuria 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 fell $1.26 per share, or 32.64%, to close at $2.60 per share on February 22, 2022.
The alleged class includes : All persons and entities other than Defendants that purchased or otherwise acquired Homology securities between June 10, 2019 and February 18, 2022, both dates inclusive.
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