FDA issues CRL for Antares' hypogonadism candidate

Antares Pharma Inc. (NASDAQ:ATRS) said FDA issued a complete response letter for Xyosted to treat hypogonadism.

The company said the CRL raised concerns that Xyosted could lead to a clinically meaningful increase in blood pressure, and noted the occurrence of depression and suicidality observed in the Phase III QST-13-003 and QST-15-005 trials of Xyosted in the indication. Antares said the letter cited no CMC, device or efficacy issues...