Biotech Stock News: Repros Stock Set For a Rise in Price

PRAN NASDAQ PRAN Prana Biotechnology

Repros Therapeutics Inc (RPRX) announced positive top-line data on its secondary hypogonadism candidate, Androxal, from a pivotal phase III study. Repros had initiated two identical, 17-week, double-blind ZA-304 and ZA-305 studies to compare the safety and efficacy of Androxal with a testosterone replacement therapy (topical gel) and placebo in restoring and maintaining testicular function.

The ZA-305 study was the first of the two identical pivotal studies. In the study, Androxal demonstrated superiority on several assessments including the two co-primary endpoints and several secondary endpoints. In patients receiving Androxal, percent change in sperm concentration from baseline was found to be unchanged. In contrast, in the testosterone gel arm, patients experienced a median 33% decrease from their baseline concentration.

Additionally, a significantly higher proportion of men exhibited mean sperm concentration ≥ 10 million/mL in the Androxal arm as compared to testosterone gel and placebo.

Biotech Stock News

Repros expects to submit a New Drug Application (NDA) to the FDA for Androxal for the secondary hypogonadism indication by the end of this year. it should be noted that an advisory panel meeting could be scheduled prior to the FDA’s final decision. If approved, Androxal has the potential to become the first drug specifically targeting secondary hypogonadism. It can be expected that the investors focus to remain on Androxal updates including data from the ZA-304 study.

Biotech News Video

Watch this video for more “Biotech” news.

[grabpress_video guid=62c4a5774f3266964d11a28ba963bd81ebc72453 embed_id=2151917]

Biotech Financial News

Repros’ shares surged 18.5% with the company reporting positive late-stage data on its key pipeline candidate, Androxal. The testosterone replacement treatment was found to be superior to a currently approved product. Repros expects to file for approval in the U.S. by year end.

Thanks for visiting the TechNews.org website. Be sure to catch all BioTech financial news, bookmark us and check all the videos and news articles regarding Biotech business news.

Signup for free to be the first to receive exclusive free links. Now in your mailbox!
Join over 15,000 subscribers
Send me links

Your information will not be shared to anyone