Repros Therapeutics says FDA gave guidance for Phase 2 study Repros Therapeutics announced the FDA has provided guidance for a Phase 2 study of low dose oral Proellex in the treatment of endometriosis. The following are the key elements of the guidance: Trial patient population includes women diagnosed within the last 5 years via laparoscopic or other surgical techniques and as having severe endometriosis requiring narcotic analgesics. The primary endpoint is percent reduction in narcotic usage to control endometriosis related pelvic pain from baseline to the end of the four month study comparing placebo to Proellex. Other endpoints include reduction in individual elements of endometriosis related pain and overall analgesic usage. Repros plans to submit the revised protocol to the FDA as soon as practicable. Once received, the FDA agreed to review the design within 30 days, at which time, if the protocol is acceptable, Repros could commence the Phase 2 trial in the fourth quarter of this year. The company intends to enroll up to 90 women into the study. The Company believes prior experience with higher dose Proellex bodes well for the eventual outcome of the trial.
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On The Fly: Analyst Initiation Summary Today's noteworthy initiations include: Altisource Residential (RESI) initiated with a Buy at Deutsche Bank... Cedar Fair (FUN) initiated with an Outperform at FBR Capital... Chimerix (CMRX) initiated with an Overweight at Piper Jaffray... GW Pharmaceuticals (GWPH) initiated with an Overweight at Piper Jaffray... Insmed (INSM) initiated with an Overweight at Piper Jaffray... Merchant Bancshares (MBVT) initiated with a Buy at Sterne Agee... Nektar (NKTR) initiated with an Overweight at Piper Jaffray... Oi S.A. (OIBR) initiated with an Outperform at Bernstein... Qunar (QUNR) initiated with a Hold at Deutsche Bank... Repros Therapeutics (RPRX) initiated with an Overweight at Piper Jaffray... Ruckus Wireless (RKUS) initiated with a Buy at Stifel... SeaWorld (SEAS) initiated with a Market Perform at FBR Capital... Six Flags (SIX) initiated with a Market Perform at FBR Capital... Twitter (TWTR) initiated with a Buy at MKM Partners... Surgical Care Affiliates (SCAI) initiated with a Buy at SunTrust.