Repros Updates Androxal(R) Global Regulatory Status
December 29, 2014 16:15 ET
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Repros Therapeutics Inc.
Full response to November meeting submitted to FDA
Repros believes all FDA questions positively addressed
Company expects contract organization to officially submit NDA to FDA...
Repros Initiates Two Phase 2B Uterine Fibroid Studies
December 29, 2014 16:15 ET
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Repros Therapeutics Inc.
Low dose oral Proellex® study in women with fibroids and heavy menstrual bleeding initiated
Vaginal administration of Proellex® in women with fibroids and heavy menstrual bleeding...
Court Rules Inventors Correctly Named on Androxal(R) Patents
December 29, 2014 09:15 ET
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Repros Therapeutics Inc.
THE WOODLANDS, Texas, Dec. 29, 2014 (GLOBE NEWSWIRE) -- Repros Therapeutics Inc.® (Nasdaq:RPRX) today announced a federal judge in Texas has issued a definitive ruling finding correct...
Repros Therapeutics Inc.(R) Reports Third Quarter 2014 Financial Results
November 10, 2014 09:00 ET
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Repros Therapeutics Inc.
THE WOODLANDS, Texas, Nov. 10, 2014 (GLOBE NEWSWIRE) -- Repros Therapeutics Inc.® (Nasdaq:RPRX) today announced financial results for the third quarter ended September 30, 2014.
Financial...
Repros Holds Constructive Meeting With FDA Regarding Androxal(R) NDA Filing
November 06, 2014 16:15 ET
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Repros Therapeutics Inc.
No New Clinical Studies Requested
Environmental Impact Assessment Plan Will be Discussed With FDA Prior to NDA Submission
Company to Host Conference Call on Friday, November 7,...
Repros to Webcast Investor and Analyst Day on October 31st
October 27, 2014 16:01 ET
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Repros Therapeutics Inc.
THE WOODLANDS, Texas, Oct. 27, 2014 (GLOBE NEWSWIRE) -- Repros Therapeutics Inc.® (Nasdaq:RPRX) today announced that it will host a live webcast of its Investor and Analyst Day that is being held...
Results From Long-Term Study of Androxal(R) Exhibit Positive Safety Profile
October 21, 2014 16:01 ET
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Repros Therapeutics Inc.
No evidence of negative effects on bone mineral density
Treatment benefit is sustained with 79.3% of subjects exhibiting normal morning testosterone after 12 months of treatment (LOCF...
Upcoming FDA Meeting to be Type C Meeting
October 16, 2014 20:01 ET
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Repros Therapeutics Inc.
THE WOODLANDS, Texas, Oct. 16, 2014 (GLOBE NEWSWIRE) -- Repros Therapeutics Inc.® (Nasdaq:RPRX) today reported that its upcoming meeting with the FDA in the first half of November will be a Type...
FDA Schedules Type B Pre-NDA Meeting With Repros
September 26, 2014 06:45 ET
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Repros Therapeutics Inc.
THE WOODLANDS, Texas, Sept. 26, 2014 (GLOBE NEWSWIRE) -- Repros Therapeutics Inc.® (Nasdaq:RPRX) today reported it has been granted a Type B Pre-NDA meeting with the FDA in the first half of...
Androxal(R) Second Pivotal Study Achieves Superiority in Top Line Analysis for Both Co-Primary Endpoints Versus Marketed Topical Gel in the Treatment of Secondary Hypogonadism
September 25, 2014 20:20 ET
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Repros Therapeutics Inc.
44.2% of Topical T subjects below 10 million sperm/mL at end of study versus 2.4% and 0.0% respectively for Androxal® and placebo ITT (Androxal® vs. Topical T, p < 0.0001)
71.5%...