On or around 01/25/2021 (Date of last review)
Filing Date: January 22, 2021
According to the Complaint, Voyager Therapeutics, Inc. is a clinical-stage gene therapy company focused on the development of treatments for patients suffering from severe neurological diseases. Included in the Company’s preclinical programs is VY-HTT01 for Huntington’s Disease.
The Complaint alleges that throughout the Class Period, Defendants made materially false and misleading statements, and failed to disclose material adverse facts about the Company's business, operational, and compliance policies. Specifically, the Complaint alleges Defendants made false and/or misleading statements and failed to disclose to investors that: (i) the Company's VY-HTT01 IND submission to the FDA lacked key information regarding certain chemistry, manufacturing and controls matters, including, inter alia, drug-device compatibility and drug substance and product characterization; (ii) the Company's IND submission for VY-HTT01 was therefore deficient; (iii) the Company had thus materially overstated the likelihood of FDA approval for VY-HTT01 based on the IND submission; and (iv) as a result, the Company's public statements were materially false and misleading at all relevant times.
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