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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.
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July 16, 2014
13:28 EDTRPRXRepros Therapeutics trial endpoints should be achieved, says Piper Jaffray
Piper Jaffray believes the endpoints selected for the Androxal Phase 3 studies for the treatment of secondary hypogonadism should be "readily achieved." Piper views the company's dialogue with the FDA as "very constructive" and reiterates an Overweight rating on Repros with a $26 price target.
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.

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