Pomerantz LLP was appointed Lead Counsel in a class action lawsuit against Antares Pharma, Inc. (“Antares” or the “Company”) and certain of its officers. The class action, filed in United States District Court, District of New Jersey, and docketed under 17-cv-08945, is on behalf of a class consisting of investors who purchased or otherwise acquired Antares securities, seeking to recover compensable damages caused by defendants’ violations of the Securities Exchange Act of 1934.
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.
On October 12, 2017, post-market, Antares disclosed that on October 11, 2017, the Company received a letter from the FDA stating that the agency had “identified deficiencies that preclude the continuation of the discussion of labeling and post marketing requirements/commitments” for Xyosted.
On this news, the Company’s share price fell $1.41, or 37.80%, to close at $2.32 on October 13, 2017.
On October 20, 2017, post-market, Antares announced receipt of a Complete Response Letter (“CRL”) from the FDA regarding the NDA for Xyosted, “indicat[ing] that the FDA cannot approve the NDA in its present form.” The Company stated, in part that “the FDA is concerned that XYOSTED could cause a clinically meaningful increase in blood pressure” and also “raised a concern regarding the occurrence of depression and suicidality.”