Antares Pharma, Inc. (ATRS) New Drug Application Delayed Over Side Effects

According to the consolidated amended complaint filed against the company's officers and directors for alleged violations of the Securities Exchange Act of 1934 between December 21, 2016 and October 12, 2017, Antares Pharma, Inc. (ATRS) announced its submission of a New Drug Application ("NDA") for Xyosted to the U.S. Food and Drug Administration ("FDA") on December 21, 2016. Antares officials spoke optimistically about the drug's potential while downplaying adverse events involving suicide and high blood pressure that occurred in Xyosted's clinical trials. On October 12, 2017, Antares revealed that FDA had "identified deficiencies that preclude the continuation of the discussion of labeling and post marketing requirements/commitments" for Xyosted. On this news, Antares' stock fell nearly 38% to close at $2.32 per share on October 13, 2017. Days earlier, Antares's Chairman of the Board, Leonard S. Jacob, sold hundreds of thousands of shares of Antares stock, reaping a windfall of nearly $1 million. On October 1, 2018, the company announced that the FDA finally had approved the drug, but required a black box warning describing risks of increased blood pressure and suicide.

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