Investigation of Voyager Therapeutics, Inc.
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Voyager Therapeutics, Inc. (VYGR) Misled Shareholders Regarding the Viability of its Lead Clinical Candidate for Huntington’s Disease
On June 1, 2017, Voyager Therapeutics, Inc. (VYGR) announced that it had selected VY-HTT01 as a lead clinical candidate for the treatment of Huntington’s disease, indicating “[p]reclinical pharmacology and toxicology studies [were] underway with VY-HTT01 to support filing of an investigational new drug (IND) application in 2018.” Throughout the relevant period, Voyager touted the viability of VY-HTT01 and continually stated that preclinical pharmacology and toxicology would support the drug’s IND application.
Finally, on September 20, 2020, Voyager submitted an IND application for VY-HTT01 for the treatment of Huntington’s disease to the U.S. Drug and Food Administration. On October 12, 2020, Voyager disclosed, “the IND was placed on clinical hold pending the resolution of certain chemistry, manufacturing and controls (CMC) matters.” Then, on November 9, 2020, Voyager announced its third quarter 2020 financial results, in which it disclosed, “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 feel $2.60 per share, or $23.21%, to close at $8.60 on November 10, 2020.