New User:

-or-
Username:
Password:
Forgot your password?

Stock Market & Financial Investment News

News Breaks
July 16, 2014
09:26 EDTRPRXRepros Therapeutics announces FDA confirmation of endpoints for Androxal
Repros Therapeutics announced it has received additional guidance from the FDA regarding primary endpoints for the two studies, ZA-304 and ZA-305, that it is currently conducting comparing Androxal to the leading approved testosterone gel and placebo. The FDA proposed three co-primary endpoints: Percentage change from baseline in sperm concentration comparing Androxal to the leading U.S. testosterone replacement therapy; proportion of men obtaining a testosterone in the normal range; percentage of men that exhibit sperm greater than or equal to 10M/mL at the end of 16 weeks of dosing and testosterone in the normal range, comparing Androxal to a testosterone gel as well as comparing Androxal to placebo. The primary endpoints and statistical analysis plan outlined for ZA-304 and ZA-305 below are being modified to comply with the FDA suggestions. The company believes the two studies are adequately powered to meet these endpoints.
News For RPRX From The Last 14 Days
Sign up for a free trial to see the rest of the stories you've been missing.
October 21, 2014
18:36 EDTRPRXOn The Fly: After Hours Movers
Subscribe for More Information
16:11 EDTRPRXRepros Therapeutics: Results from Androxal study exhibit positive safety profile
Repros Therapeutics reported results from a large, controlled, long-term safety study comparing Androxal to a placebo. In this study of Androxal, ZA-303, no new safety signals were identified, including no evidence of negative effects on bone mineral density. Over 79% of the Androxal-treated subjects had morning testosterone levels above 300 ng/dL after being treated for 12 months. The last patient completed this study in late September. The Company's planned NDA will include study ZA-303, which will provide a significant portion of the support of long-term safety by providing data from 141 subjects exposed for one year or more. Over 200 subjects reached this milestone in the entire exposure database. ICH guidance for drugs to treat non-life-threatening conditions suggests that a minimum of 100 subjects should be exposed to the drug for one year.
October 17, 2014
09:17 EDTRPRXOn The Fly: Pre-market Movers
Subscribe for More Information
October 16, 2014
20:03 EDTRPRXRepros Therapeutics upcoming meeting with FDA to be Type C, not Type B
Subscribe for More Information
07:41 EDTRPRXRepros Therapeutics management to meet with Brean Capital
Subscribe for More Information
October 13, 2014
12:33 EDTRPRXOptions with increasing implied volatility
Subscribe for More Information

Sign up for a free trial to see the rest of the stories you've been missing.

I agree to the theflyonthewall.com disclaimer & terms of use