According to the law firm press release, Antares develops pharmaceutical delivery systems, including needle-free and mini-needle injector systems and transdermal gel technologies. The Company distributes its needle-free injector systems in various countries. Antares also conducts research and development with transdermal gel products and has several products in clinical evaluation with partners.
Antares’s product Xyosted (originally known as QuickShot Testosterone or QST) has been among the Company’s lead product candidates at all relevant times. Antares announced its submission of a New Drug Application (“NDA”) for Xyosted to the U.S. Food and Drug Administration (“FDA”) on December 21, 2016.
The Complaint alleges that throughout the Class Period, Defendants made materially false and misleading statements regarding the Company’s business, operational and compliance policies. Specifically, Defendants made false and/or misleading statements and/or failed to disclose that: (i) Antares had provided insufficient data to the FDA in connection with its NDA for Xyosted; (ii) accordingly, Antares had overstated the approval prospects for Xyosted; and (iii) as a result of the foregoing, Antares’ public statements were materially false and misleading at all relevant times.