Repros Therapeutics Inc. said its marketing application for enclomiphene in secondary hypogonadism is likely to receive a negative opinion in January 2018 from a European Medicines Agency committee.
The company received feedback regarding the forthcoming option, which will be issued by the Committee for Medicinal Products for Human Use, following an oral explanation.
The application was submitted by Renable Pharma Ltd., the company's U.K. unit.
Hypogonadism is a form of testosterone deficiency in adult males.
Allergan plc is in the process of acquiring Repros Therapeutics.