Homology Medicines, Inc.

Investigation
02/18/2022

Initial Lawsuit
03/25/2022

Lawsuit Progression
07/01/2022

Investigation

Continous Holding
June 10, 2019 to February 18, 2022
Proposed Claim
Securities Violation

Did Homology Medecines, Inc. mislead shareholders regarding the pheNIX gene therapy trial of HMI-102 in adults with phenylketonuria (PKU) and the clinical hold by the U.S. Food and Drug Administration (FDA)?

This post is open for investors to gather facts, and findings and track their exposure to related lawsuits. We invite investors and shareholders to contribute to this investigation for their own benefit, add events to the factual timeline below and vote on events’ pertinence.

A lawsuit was subsequently filed. We will update this post as it unfolds.

Main Event

Clinical Hold

02/18/2022

SEC Filing

Homology discloses notification by the U.S. Food and Drug Administration (FDA) of a clinical hold on the pheNIX gene therapy trial of HMI-102 in adults with phenylketonuria (PKU) “due to the need to modify risk mitigation measures in the study in response to observations of elevated liver function tests.”

“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.”

The stock impact compares the closing price immediately preceding the date of the event and the following closing price. The price difference also reflects the overall mix of information.

Stock Impact

Close	Previous close	Price variation	Percentage variation
$3.86	$3.87	$-0.01	-0.26%

See more on Factual Timeline

Initial Lawsuit

First Complaint - 03/25/2022

A Homology Medicines, Inc. (FIXX) shareholder filed a federal securities class action lawsuit on behalf of a class consisting of all persons and entities (other than the defendants) that purchased or otherwise acquired Homology securities between June 10, 2019, and February 18, 2022, both dates inclusive.

Filing Date
03/25/2022
Class Period
06/10/2019 to 02/18/2022
Transgression
Securities Violation
Filing Firms
Pomerantz LLP
Case Title
Michael C. Pizzuto v. Homology Medicines, Inc. et al
Docket Number
2:22-cv-01968
Court
California Central District Court
Free File
Complaint

Allegations

According to the complaint, defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the company’s business, operations, and prospects. Specifically, defendants allegedly failed to disclose to investors 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.