Repros Therapeutics Inc. (RPRX) recently released additional results from its phase III study, ZA-300, on candidate Androxal.
Repros is evaluating Androxal for the treatment of low testosterone due to secondary hypogonadism.
The results from the study showed that the change from baseline in total testosterone compared to baseline values was statistically different at various measurements including the two follow-up visits, for the 12.5 mg dose.
The change was statistically significant at 25 mg dose as well but the change was not significant after follow-up visists at the end of two months. The results also showed that patients continued to benefit even after withdrawal of treatment.
In Sep 2013, Repros had announced that Androxal was generally well tolerated in the six-month safety study, ZA-300. We remind investors that Repros had announced encouraging top-line results in Sep 2013, from its second phase III study, ZA-302, on Androxal. The study met both co-primary endpoints as mandated by the U.S. Food and Drug Administration (:FDA).
Last week, share price of Repros surged after its meeting with the FDA. The meeting was held to discuss phase III data requirements to file a New Drug Application (:NDA) for Androxal. Post meeting, the company came to the conclusion that no additional safety studies would be required to support the NDA submission of Androxal. The safety of Androxal will stand on its own merit during NDA review.
Repros expects to submit the NDA to the regulatory body by end 2014.
Repros currently carries a Zacks Rank #3 (Hold). Androxal is the most advanced candidate in Repros pipeline. Hence, we expect investor focus to remain on Androxal updates. Some better-ranked players in the pharma industry include Actelion Ltd. (ALIOF), Endocyte Inc. (ECYT) and Biogen Idec Inc. (BIIB). All the three stocks carry a Zacks Rank #1 (Strong Buy).