Lawsuit Overview
May 29, 2020 - A third amended consolidated complaint was filed.
April 28, 2020 - The court granted the defendants' motion to dismiss. The plaintiffs were given leave to amend the complaint.
July 29, 2019 - A second amended consolidated complaint was filed.
June 30, 2019 - The court granted the defendants' motion to dismiss. The plaintiffs were given leave to amend the complaint.
November 26, 2018 - A motion to dismiss the amended consolidated complaint was filed.
October 9, 2018 - An amended consolidated complaint was filed.
October 23, 2017 - An investor in shares of Antares Pharma Inc (NASDAQ: ATRS) filed a lawsuit in the U.S. District Court for the District of New Jersey over alleged violations of Federal Securities Laws by Antares Pharma Inc in connection with certain allegedly false and misleading statements made between December 21, 2016 and October 12, 2017.
Ewing, NJ based Antares Pharma Inc is a specialty pharmaceutical company that focuses on developing and commercializing self-administered parenteral pharmaceutical products and technologies. Antares Pharma Inc’s product Xyosted (originally known as QuickShot Testosterone or QST) has been among the Company’s lead product candidates at all relevant times. Antares Pharma Inc announced its submission of a New Drug Application (“NDA”) for Xyosted to the U.S. Food and Drug Administration (“FDA”) on December 21, 2016.
On October 12, 2017, Antares Pharma Inc announced that, on October 11, 2017, the Company received a letter from the U.S. Food and Drug Administration (“FDA”) stating that, as part of their ongoing review of the Company’s NDA for XYOSTED™ injection, they have identified deficiencies that preclude the continuation of the discussion of labeling and postmarketing requirements/commitments at this time.
On October 20, 2017, Antares Pharma Inc 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.” Antares Pharma Inc 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.”
According to the complaint the plaintiff alleges on behalf of purchasers of Antares Pharma Inc (NASDAQ: ATRS) common shares between December 21, 2016, and October 12, 2017, that the defendants violated Federal Securities Laws. More specifically, the plaintiff claims that between December 21, 2016 and October 12, 2017, the made false and/or misleading statements and/or failed to disclose that Antares Pharma Inc had provided insufficient data to the FDA in connection with its NDA for Xyosted, that accordingly, Antares Pharma Inc had overstated the approval prospects for Xyosted, and that as a result of the foregoing, Antares Pharma Inc’s public statements were materially false and misleading at all relevant times.