|Company name||Antares Pharma, Inc.|
|Class period||December 21, 2016 – October 12, 2017|
|Lead plaintiff deadline||December 22, 2017|
|Court||District of New Jersey|
NEW YORK, October 25, 2017 – Bragar Eagel & Squire, P.C. announces that a class action lawsuit has been filed in the U.S. District Court for the District of New Jersey on behalf of all persons or entities who purchased or otherwise acquired Antares Pharma, Inc. (NASDAQ: ATRS) securities between December 21, 2016 and October 12, 2017 (the “Class Period”). Investors have until December 22, 2017 to apply to the Court to be appointed as lead plaintiff in the lawsuit.
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.”
If you purchased or otherwise acquired Antares securities during the Class Period or continue to hold shares purchased prior to the Class Period, have information, would like to learn more about these claims, or have any questions concerning this announcement or your rights or interests with respect to these matters, please contact Brandon Walker or Melissa Fortunato by email at firstname.lastname@example.org, or telephone at (212) 355-4648, or by filling out the contact form below. There is no cost or obligation to you.