Repros Therapeutics Inc.’s lead pipeline candidate, Androxal, is being evaluated for the treatment of patients with secondary hypogonadism. The company received guidance from the U.S. Food and Drug Administration (FDA) related to the Androxal development program on Oct 22, 2013.
Repros now expects to submit the new drug application (NDA) to the U.S. Food and Drug Administration (FDA) in the fourth quarter of 2014. Earlier, the company had planned on submitting the NDA in mid-2014 with potential launch in 2015.
Investors reacted negatively to the delay in the potential approval of Repros. The stock price of Repros fell significantly the following day. Though the stock price has recovered marginally, overall the stock lost 24.6% since the announcement.
The FDA has requested a meeting to discuss the data from two pivotal studies, ZA-301 and ZA-302 on Androxal. The FDA wants to determine whether the company should include men referred from a fertility clinic (site 9) in its final analysis of Study ZA-301.
We note that earlier this year, the company had announced encouraging top-line data from the first pivotal phase III study (ZA-301) and the second pivotal efficacy study (ZA-302). Both, ZA-301 and ZA-302 – conducted under the FDA’s Special Protocol Assessment (SPA) program – had met the two their respective primary endpoints.
As the FDA will consider different sperm endpoints than those outlined in the SPA, the company plans to conduct two studies (12 weeks and 18 weeks) and finalize the design for the same.
The FDA has agreed to studies comparing Androxal to approved testosterone replacement therapies. Repros stands to benefit from the additional trials as data if positive can be added to the label.
Currently prescribed therapies for secondary hypogonadism include AbbVie Inc.’s (ABBV - Free Report) AndroGel.
Repros currently carries a Zacks Rank #3 (Hold). We expect investor focus to remain on Androxal updates.
However, companies like Actelion Ltd. and Roche (RHHBY - Free Report) look more attractive with a Zacks Rank #1 (Strong Buy).