Horizon Pharma PLC (NASDAQ:HZNP) has acquired rights to sell and market Nuvo Research's (NRI.TO) PENNSAID 2% topical osteoarthritis cure in the U.S. for US$45 million (C$50 million). Horizon will assume U.S. commercialization of PENNSAID 2% from Nuvo's former U.S. marketing licensee on January 1, 2015. Nuvo will supply PENNSAID 2% to Horizon Pharma PLC (NASDAQ:HZNP) for the U.S. market but will retain all rights to the product outside of the U.S. HZNP has a 52-week range of $3.70 - $18.30.Repros Therapeutics Inc (NASDAQ:RPRX) a company focused on reproductive disorder drug development, announced its November meeting with the U.S. Food and Drug Administration (FDA) will be a Type C guidance meeting rather than the Type B Pre-NDA meeting that was expected. The FDA said that based on its preliminary review of RPRX's briefing document there was not sufficient clinical information for a Pre-NDA meeting. Repros Therapeutics Inc (NASDAQ:RPRX) said it does not know why the FDA believes the clinical information to be insufficient, but notes that synopses for the one year DEXA safety study and the Drug-Drug Interaction Study, which it believes may be significant to the FDA's review, were not available at the time the briefing document was submitted to the FDA. Shares of RPRX are trading within a 52-week range of $8.46 - $26.14.Myriad Genetics, Inc. (NASDAQ:MYGN) has slashed its Q1 revenue and EPS guidance to significantly below analysts estimates as the national launch of a new cancer test led to higher-than-expected demand, pushing up costs and turnaround times. Myriad Genetics, Inc. (NASDAQ:MYGN) now expects Q1 adjusted earnings of $0.25, below forecasts for $0.42, according to Capital IQ. It sees revenue of $168 million below estimates for $183 million. However, Myriad said that it expects to be able to increase capacity and reduce turnaround in the second half of 2015. The company reiterated its 2015 forecasts of total revenues of $800 to $820 million and adjusted earnings per share of $1.90 to $2.00.Analysts were looking for EPS of $192 on revenue of $802 million. Myriad said sample volumes for its myRisk Hereditary Cancer test represent more than 50 percent of all hereditary cancer samples received. Also Friday, Myriad said Palmetto GBA, a Medicare Administrative Contractor that assesses molecular diagnostic technologies, has issued a draft local coverage determination for Prolaris, the company's prostate cancer test. The current language in the draft LCD provides reimbursement coverage for the approximately 50% of prostate cancer patients defined as low and very low risk. Under Medicare rules, the draft LCD is subject to a minimum 45-day public comment period. After comments are considered, a final LCD is issued, which goes into effect after a minimum 45-day notification period. Myriad shares have a 52-week range of $20.02 - $42.50.
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