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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
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March 24, 2015
14:18 EDTRPRXRepros Therapeutics April volatility elevated at 144
Repros Therapeutics April call option implied volatility is at 144, May is at 108, August is at 107; compared to its 26-week average of 103 according to Track Data, suggesting large near term price movement
March 16, 2015
14:54 EDTRPRXFDA accepting Androxal NDA can be catalyst for Repros, says Brean Capital
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09:28 EDTRPRXRepros Therapeutics reports Q4 EPS (31c), consensus (34c)
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