Quick Facts
FONT-SIZE Plus   Neg
Share SHARE

Repros Therapeutics To Meet With FDA To Discuss Phase 3 Study Design Of Androxal

Repros Therapeutics Inc.(RPRX: Quote) Monday said the FDA has scheduled a meeting in May to discuss the design of pivotal Phase 3 efficacy studies for Androxal, as well as the components of the overall drug development program required for NDA submission.

Androxal is an oral therapy intended for the treatment of secondary hypogonadism. Unlike the hormone replacement therapies currently approved to treat this disorder, Androxal restores testicular function resulting in normal synthesis of testosterone and continued spermatogenesis.

Repros said studies using approved testosterone replacement therapies as efficacy and safety comparators have shown the approved treatments result in suppression of important pituitary hormones that drive testicular function down to castration levels in a significant number of men.

Joseph Podolski, president and CEO of The Woodlands, Texas-based company, said," Our goal is to work with the FDA to provide a complete drug dossier for Androxal that exhibits the products' clinical benefit and safety. Depending on FDA comments, we believe we can submit the NDA early in 2014."

RPRX closed Monday's regular trade at $4.35, down $0.15 or 3.33%, on the Nasdaq. In the after-hours, the stock gained $0.01 or 0.23%. Over the past year, the stock traded in a range of $3.34 - $6.85.

Register
To receive FREE breaking news email alerts for REPROS THERAPEUTICS INC. and others in your portfolio

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Specialty drugmaker Horizon Pharma plc (HZNP) on Friday managed to redomicile itself as an entity incorporated in Ireland following the completion of its $660 million acquisition of Vidara Therapeutics International plc. The deal will help it avoid paying the high rate of U.S. corporate taxes. The... Stocks showed a lack of direction over the course of the trading day on Friday after failing to sustain an initial upward move. Despite the choppy trading, the Dow once again managed to end the session at a new record closing high. The major averages turned in a mixed performance on the day. President Barack Obama delivered a statement Thursday evening thanking members of Congress for voting to approve legislation granting the U.S. military the authority to train and arm moderate Syrian rebels fighting against the terrorist group known as the Islamic State.
comments powered by Disqus
FREE Newsletters, Analysis & Alerts

 

Stay informed with our FREE daily Newsletters and real-time breaking News Alerts. Sign up to receive the latest information on business news, health, technology, biotech, market analysis, currency trading and more.