Voyager Therapeutics, 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 Eastern District of New York on behalf of those who acquired Voyager Therapeutics, Inc. (“Voyager” or the “Company”) (NASDAQ: VYGR) securities during the period from June 1, 2017 through November 9, 2020 (the “Class Period”). Investors have until March 24, 2021 to apply to the Court to be appointed as lead plaintiff in the lawsuit.
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.
If you purchased or otherwise acquired Voyager securities, have information, or would like to learn more about these claims, please contact Thomas W. Elrod of Kirby McInerney LLP at 212-371-6600, by email at firstname.lastname@example.org, or by filling out this contact form, to discuss your rights or interests with respect to these matters without any cost to you.