January 22, 2021 - An investor in shares of Voyager Therapeutics, Inc. (NASDAQ: VYGR) filed a lawsuit in the U.S. District Court for the Eastern District of New York over alleged violations of Federal Securities Laws by Voyager Therapeutics, Inc. in connection with certain allegedly false and misleading statements made between June 1, 2017 and November 9, 2020.
Cambridge, MA based Voyager Therapeutics, Inc., 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 Therapeutics, Inc 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. Voyager Therapeutics, Inc. reported that its annual Total Revenue rose from $7.61 million in 2018 to $104.39 million in 2019, and that its normalized Loss declined from $88.28 million in 2018 to $43.59 million in 2019.
On October 12, 2020, Voyager Therapeutics, Inc. disclosed 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. Shares of Voyager Therapeutics, Inc. (NASDAQ: VYGR) declined on October 13, 2020 to $10.90 per share. Then, on November 9, 2020, Voyager Therapeutics, Inc announced the Company's third quarter 2020 financial results and corporate updates. In the announcement, Voyager Therapeutics, Inc 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.
According to the complaint the plaintiff alleges on behalf of purchasers of Voyager Therapeutics, Inc. (NASDAQ: VYGR) common shares between June 1, 2017 and November 9, 2020, that the defendants violated Federal Securities Laws. More specifically, the plaintiff claims that between June 1, 2017 and November 9, 2020, the defendants made false and/or misleading statements and failed to disclose to investors that 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, that the Company's IND submission for VY-HTT01 was therefore deficient, that the Company had thus materially overstated the likelihood of FDA approval for VY-HTT01 based on the IND submission, and that as a result, the Company's public statements were materially false and misleading at all relevant times.