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News Breaks
February 6, 2014
05:50 EDTRPRXRepros Therapeutics meets with FDA to discuss data requirements for Androlax
Repros Therapeutics announced the outcome of its previously announced meeting with the FDA regarding the Androxal Phase 3 data requirements for an NDA in the treatment of secondary hypogonadism. Repros expects to maintain its timeline for submitting an NDA prior to the end of 2014. This submission will include studies ZA-304 and ZA-305 which were initiated in January 2014. Following the meeting, the Company understands that the safety of Androxal will stand on its own merits during NDA review and no additional safety assessments are currently planned prior to NDA submission. The FDA requested additional background information regarding the endpoints that the company will use to confirm maintenance of fertility by semen assessments in studies ZA-304 and ZA-305. The company plans to provide this information promptly to the FDA and while doing so to continue enrollment of ZA-304 and ZA-305 without interruption.
News For RPRX From The Last 14 Days
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October 29, 2014
09:51 EDTRPRXRepros Therapeutics to host investor and analyst day
Investor and Analyst Day to be held in New York on October 31 at 7:30 am.
October 23, 2014
14:00 EDTRPRXRepros Therapeutics volatility elevated as shares trade near two-year low
Repros Therapeutics overall option implied volatility of 158 is above its 26-week average of 93 according to Track Data, suggesting large price movement.
October 21, 2014
18:36 EDTRPRXOn The Fly: After Hours Movers
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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
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