Repros Delays ZA-301 Study Results - Analyst Blog


Shutterstock photo

Repros Therapeutics Inc. ( RPRX ) recently announced that results from the first pivotal study (ZA-301) of Androxal will be declared in the third quarter of 2013 instead of the second quarter. The candidate is being evaluated for the treatment of secondary hypogonadism.

In this study, the patient population of one of the sites which had enrolled 40 subjects was found to be different from the other 16 sites where baseline sperm count was concerned. Thus, Repros considered it wise to remove this site from the study and replace the subjects with those enrolled at other sites.

The Androxal phase III program includes two identical pivotal phase III studies, ZA-301 and ZA-302. Enrollment for ZA-302 is expected to be completed by the first quarter of 2013. The shortfall of subjects in ZA-301 would be made up by moving enrolled subjects from the ZA-302 study.

The company still expects to file a New Drug Application (NDA) for Androxal by mid-2014.

Meanwhile, earlier this year, the company announced that it has completed the enrollment process for the one-year study, DEXA (ZA-303), evaluating the effects of Androxal on bone mineral density.

Our Take

The delay in the company's plans for reporting ZA-301 results is disappointing. We note that the market for the treatment of secondary hypogonadism is already crowded given the presence of drugs like AbbVie Inc. 's ( ABBV ) Androgel, Auxilium Pharmaceuticals Inc. 's ( AUXL ) Testim and Eli Lilly and Company 's ( LLY ) Axiron.

While Repros carries a Zacks Rank #3 (Hold), Eli Lily carries a Zacks Rank #2 (Buy).

ABBVIE INC (ABBV): Free Stock Analysis Report

AUXILIUM PHARMA (AUXL): Free Stock Analysis Report

LILLY ELI & CO (LLY): Free Stock Analysis Report

REPROS THERAPEU (RPRX): Free Stock Analysis Report

To read this article on click here.

Zacks Investment Research

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

This article appears in: Investing , Business , Stocks
Referenced Stocks: ABBV , AUXL , LLY , RPRX

More from


Equity Research
Follow on:

Find a Credit Card

Select a credit card product by:
Select an offer:
Data Provided by