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News Breaks
August 27, 2012
16:13 EDTRPRXRepros Therapeutics says FDA gave guidance for Phase 2 study
Repros Therapeutics announced the FDA has provided guidance for a Phase 2 study of low dose oral Proellex in the treatment of endometriosis. The following are the key elements of the guidance: Trial patient population includes women diagnosed within the last 5 years via laparoscopic or other surgical techniques and as having severe endometriosis requiring narcotic analgesics. The primary endpoint is percent reduction in narcotic usage to control endometriosis related pelvic pain from baseline to the end of the four month study comparing placebo to Proellex. Other endpoints include reduction in individual elements of endometriosis related pain and overall analgesic usage. Repros plans to submit the revised protocol to the FDA as soon as practicable. Once received, the FDA agreed to review the design within 30 days, at which time, if the protocol is acceptable, Repros could commence the Phase 2 trial in the fourth quarter of this year. The company intends to enroll up to 90 women into the study. The Company believes prior experience with higher dose Proellex bodes well for the eventual outcome of the trial.
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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