Antares dips on FDA request for testosterone safety data

Antares Pharma Inc. (NASDAQ:ATRS) shed $0.15 to $2.46 on Tuesday after FDA told the company to expand its safety database related to QuickShot Testosterone, which is being tested in a Phase III trial to treat hypogonadism. Antares said the request was based on a single reported occurence of hives in a Phase II trial of the compound as well as known safety experience with other parenteral testosterone products.

Antares said it does not believe the case of hives was related to the self-injectable formulation of testosterone enanthate delivered using Antares' Vibex autoinjector technology. ...