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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.
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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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