NEW YORK, NY / ACCESSWIRE / March 16, 2021 / Pomerantz LLP announces that a class action lawsuit has been filed against Voyager Therapeutics, Inc. ("Voyager" or the "Company") (NASDAQ:VYGR) and certain of its officers. The class action, filed in United States District Court for the Eastern District of New York, and docketed under 21-cv-00381, is on behalf of a class consisting of all persons and entities other than Defendants that purchased or otherwise acquired Voyager securities between June 1, 2017 and November 9, 2020, both dates inclusive (the "Class Period"), seeking to recover damages caused by Defendants' violations of the federal securities laws and to pursue remedies under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 (the "Exchange Act") and Rule 10b-5 promulgated thereunder, against the Company and certain of its top officials.
If you are a shareholder who purchased Voyager securities during the Class Period, you have until March 23, 2021 to ask the Court to appoint you as Lead Plaintiff for the class. A copy of the Complaint can be obtained at www.pomerantzlaw.com. To discuss this action, contact Robert S. Willoughby at [email protected] or 888.476.6529 (or 888.4-POMLAW), toll-free, Ext. 7980. Those who inquire by e-mail are encouraged to include their mailing address, telephone number, and the number of shares purchased.
Voyager, a clinical-stage gene therapy company, focuses 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. Voyager represent that VY-HTT01 is intended to work by knocking down HTT expression in neurons and astrocytes in the striatum and cortex (discrete regions in the brain that can be targeted with adeno-associated virus ("AAV") gene therapy delivered directly into the brain), thereby reducing the level of toxicity associated with mutated protein in these brain regions, and slowing the progression of cognitive and motor symptoms.
On June 1, 2017, Voyager issued a press release announcing that it had selected VY-HTT01 as a lead clinical candidate for the treatment of Huntington's disease. The press release also indicated that, "[p]reclinical pharmacology and toxicology studies [were] underway with VY-HTT01 to support filing of an investigational new drug (IND) application in 2018."
In September 2020, Voyager submitted an investigational new drug ("IND") application for VY-HTT01 for the treatment of Huntington's disease to the U.S. Food and Drug Administration ("FDA").
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, 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 ("CMC") 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.
On October 12, 2020, Voyager issued a press release disclosing that it "has received feedback from the U.S. Food and Drug Administration (FDA) on the Investigational New Drug (IND) submission for VY-HTT01 for the treatment of Huntington's disease." Specifically, Voyager advised investors that it "has been notified that the IND was placed on clinical hold pending the resolution of certain chemistry, manufacturing and controls (CMC) matters."
Then, on November 9, 2020, Voyager issued a press release announcing the Company's third quarter 2020 financial results and corporate updates. In the press release, the Company disclosed that, with respect to its IND application for VY-HTT01, "Voyager recently received written feedback from the FDA requesting additional information on specific CMC topics, including drug-device compatibility and drug substance and product characterization."
On this news, Voyager's stock price fell $2.60 per share, or 23.21%, to close at $8.60 per share on November 10, 2020.
The Pomerantz Firm, with offices in New York, Chicago, Los Angeles, and Paris is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, the Pomerantz Firm pioneered the field of securities class actions. Today, more than 80 years later, the Pomerantz Firm continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered numerous multimillion-dollar damages awards on behalf of class members. See www.pomerantzlaw.com
SOURCE: Pomerantz LLP