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August 22, 2014
11:05 EDTRPRXPiper Jaffray biopharm analyst holds an analyst/industry conference call
Biopharmaceuticals Analyst Schimmer provides an overview of Repros Therapeutics on an Analyst/Industry conference call to be held on August 22 at 11:30 am.
News For RPRX From The Last 14 Days
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December 1, 2015
12:42 EDTRPRXApricus Biosciences confirms clinical strategy for development of fispemifene
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09:51 EDTRPRXRepros receives complete response letter from FDA for enclomiphene
Repros Therapeutics announced that it has received a Complete Response Letter from the U.S. Food and Drug Administration for its New Drug Application for enclomiphene for the treatment of secondary hypogonadism in overweight men wishing to restore normal testicular function. A Complete Response Letter is a communication from the FDA that informs companies that an application cannot be approved in its present form. In the letter, the FDA stated that, based on recent scientific developments, the design of enclomiphene Phase 3 studies is no longer adequate to demonstrate clinical benefit and recommended that Repros conduct an additional Phase 3 study or studies to support approval in the target population. The FDA also noted concerns regarding study entry criteria, titration and bioanalytical method validation in the Phase 3 program. Repros plans to work with the FDA to determine an appropriate path forward to address these comments. "We are disappointed that the FDA has taken this position without the benefit of an advisory committee recommendation. We plan to work closely with the Agency to gain more information to determine the appropriate next steps regarding the enclomiphene application," said Joseph Podolski, President and CEO of Repros.
09:50 EDTRPRXRepros receives complete response letter From FDA for enclomiphene
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November 30, 2015
07:56 EDTRPRXFDA PDUFA Date for Repros Therapeutics Enclomiphene is November 30, 2015
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