Antares falls on Xyosted update

Antares Pharma Inc. (NASDAQ:ATRS) plummeted $1.41 (38%) to $2.32 on Friday following its announcement late Thursday that FDA has identified unspecified deficiencies in the NDA for Xyosted testosterone enanthate that preclude continuing discussions about labeling and postmarketing requirements at this time. The company expects further clarification from the agency on or before Oct. 20, which is the NDA’s PDUFA date.

Antares said it received and responded to labeling comments from FDA for the NDA in September. The company submitted the NDA in December under section 505(b)(2) of the Food, Drug and Cosmetic Act, which allows sponsors to reference data on safety and efficacy from the scientific literature or from previously approved products...