Shares of Repros Therapeutics Inc. have been on an upswing since the announcement of encouraging top-line data from the second pivotal efficacy study (ZA-302) and six-month safety study (ZA-300) on its lead pipeline candidate, Androxal. The company is evaluating the use of Androxal for the treatment of patients with secondary hypogonadism.
The subsequent announcement of additional positive top-line data from the ZA-302 study helped in the maintenance of the upward trend. We note that ZA-302 met both the primary endpoints. The results showed that 81% of the patients had average total testosterone in a normal range as compared to 26% in placebo. The second primary endpoint was related to the drug’s impact on sperm concentration. Results did not reveal any harmful effects of Androxal on sperm function.
We note that earlier this year, the company had announced encouraging top-line data from the first pivotal phase III study (ZA-301). ZA-301 had met both the primary endpoints. Both ZA-302 and ZA-301 were conducted under the FDA’s Special Protocol Assessment program.
Repros also reported encouraging data from the ZA-300 study on Androxal. The company stated that Androxal was generally well-tolerated.
The company is on track to file a New Drug Application to the U.S. Food and Drug Administration (FDA) for Androxal by mid 2014 with potential launch in 2015.
Currently prescribed therapies for secondary hypogonadism include AbbVie Inc.’s (ABBV - Free Report) AndroGel.
Repros currently carries a Zacks Rank #2 (Buy). We expect investor focus to remain on Androxal updates.
Currently, companies like Actelion Ltd. and Biogen Idec Inc. (BIIB - Free Report) look more attractive with a Zacks Rank #1 (Strong Buy).