Antares Pharma, Inc. (ATRS) Accused of Overstating Approval Prospects for its Drug
According to the complaint, on December 21, 2016, Antares announced its submission of a New Drug Application (“NDA”) for Xyosted to the U.S. Food and Drug Administration (“FDA”) and spoke optimistically about the drug’s potential. However, Antares officials provided insufficient data to the FDA for the NDA and overstated the approval prospects for Xyosted. 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. On October 20, 2017, Antares announced receipt of a Complete Response Letter from the FDA stating that the FDA cannot approve the NDA due to concerns about increase in blood pressure and the occurrence of depression and suicidality.