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February 21, 2013
07:16 EDTRPRXRepros Therapeutics reports FDA recommends study of Androxal to be completed
Repros Therapeutics provided a clinical update of its Androxal Phase 3 program following receipt of written guidance from the FDA. The FDA has informed Repros to proceed with the analysis of ZA-301 as previously planned, and that data should be evaluated both with and without patients from the high enrolling site where the patients' baseline characteristics appeared different from other sites in the study. Additionally, the FDA accepted Repros' plan regarding study ZA-302 to enroll additional patients. They also noted that Repros should revise the statistical analysis plan and sample size to reflect increased enrollment. Study ZA-302 will also be analyzed with and without patients from the high enrolling site where the patients' baseline characteristics appeared different from other sites in the study.
News For RPRX From The Last 14 Days
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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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October 16, 2014
20:03 EDTRPRXRepros Therapeutics upcoming meeting with FDA to be Type C, not Type B
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07:41 EDTRPRXRepros Therapeutics management to meet with Brean Capital
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October 13, 2014
12:33 EDTRPRXOptions with increasing implied volatility
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