Repros Therapeutics Inc. (RPRX) submitted a New Drug Application (NDA) for its lead candidate Androxal. Repros is looking to get the candidate approved for the treatment of secondary hypogonadism in overweight men wishing to restore normal testicular function.

Towards the end of last year Repros announced the submission of a complete response to the guidance provided by the FDA regarding the expected NDA submission for Androxal. In Nov 2014, Repros had received a detailed guidance regarding the filing of the candidate.

While providing its guidance, the FDA said that no additional studies were required for the NDA filing of Androxal. However, the FDA stated that the company may require additional safety studies, particularly on cardiovascular risks, in the future.

The company expects to submit regulatory application in the EU in the first quarter of 2016. The company is seeking New Chemical Entity status for the product.

AbbVie Inc.'s (ABBV) AndroGel is one of the currently available treatments for hypogonadism in the market.

Androxal’s success is crucial for Repros as it has no approved product in its portfolio yet. The company has been struggling with higher research and development expenses over the last few quarters. We expect investor focus to stay on the regulatory status of Androxal going forward.

Repros carries a Zacks Rank #2 (Buy). Other favorable stocks in the health care space include Celgene Corp. (CELG) and AMAG Pharmaceuticals, Inc. (AMAG). While Celgene sports a Zacks Rank #1 (Strong Buy), AMAG carries a Zacks Rank #2.

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