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News Breaks
February 11, 2013
09:29 EDTRPRXRepros updates Adroxal study, requests end of Proellex Phase 2 study
Repros Therapeutics provided an update for both of its core clinical programs. As part of the FDA requirement for total number of subjects to be exposed for six months, the company is conducting a 500 subject open label study. To date, the company has enrolled 499 subjects and expects the study to be fully enrolled this week. The company has sent a "request for guidance" letter to the FDA. The key points were the identification of a single high enrolling site with a population whose baseline characteristics appear different from the other sites; the company has proposed enrolling an additional 40 subjects into each of the two pivotal studies to allow for subset analysis while retaining the power of the original protocols; the company proposed moving two sites from the enrolling study ZA-302 to the closed for enrollment study ZA-301. When the company receives guidance from FDA, it will update the financial community. The company has requested an end of Phase 2 meeting for its vaginal Proellex program for the treatment of uterine fibroids. The request was for a meeting before the end of April.
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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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