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Stock Market & Financial Investment News

News Breaks
January 10, 2014
10:20 EDTSHPG, CHTPChelsea falls after FDA staff call droxidopa approval decision 'complex'
Shares of Chelsea Therapeutics (CHTP) are sharply lower in early trading after the FDA posted briefing documents related to a review of a resubmission for the company's droxidopa drug. The documents are related to a cardiovascular and renal drug advisory committee meeting scheduled for January 14. WHAT'S NEW: Chelsea Therapeutics is seeking approval of droxidopa for “the treatment of symptomatic neurogenic orthostatic hypotension in patients with primary autonomic failure, which includes Parkinson’s Disease, Multiple System Atrophy and Pure Autonomic Failure, as well as to treat two other conditions. In the document, FDA staff wrote that the decision whether or not to approve droxidopa is "complex," noting that strong evidence from one clinical trial indicates that droxidopa confers "at least one week of symptomatic benefit," but also that there has been no durable effect, i.e., more than 1 week, demonstrated for droxidopa. The document also notes that Shire (SHPG), the sponsor of midodrine, an approved drug for symptomatic orthostatic hypotension, is currently being tasked with completing 2 adequate and well controlled trials to demonstrate that drug’s symptomatic benefit. The document also states that there were "numerous concerning safety findings" related to droxidopa. PRICE ACTION: In morning trading, shares of Chelsea Therapeutics are down over 29% to $2.50. Reference Link
News For CHTP;SHPG From The Last 14 Days
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November 19, 2014
09:28 EDTSHPGShire to establish Lexington, Massachusetts as U.S. operational headquarters
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09:26 EDTSHPGShire appoints Poulton as interim CFO
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07:08 EDTSHPGSangamo says study demonstrates in vivo reversal of Huntington's disease signs
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November 18, 2014
06:39 EDTSHPGAstraZeneca: 'Hard to comment' on whether Pfizer will come back, Reuters reports
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November 14, 2014
17:27 EDTSHPGPaulson & Co. gives quarterly update on stakes
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17:13 EDTSHPGAppaloosa gives quarterly update on stakes
NEW STAKES: NXP Semiconductors (NXPI), Lorillard (LO), Alibaba (BABA), and Shire (SHPG). INCREASED STAKES: Whirlpool (WHR), Priceline (PCLN), Delta (DAL), CBS (CBS), and General Motors (GM). DECREASED STAKES: American Airlines (AAL), Disney (DIS), Apple (AAPL), MGM Resorts (MGM), and Eastman Chemical (EMN). LIQUIDATED STAKES: Expedia (EXPE), AIG (AIG), Prudential (PRU), Celanese (CE), and ASML Holding (ASML).
16:58 EDTSHPGThird Point gives quarterly update on stakes
NEW STAKES: Alibaba (BABA), eBay (EBAY), Bed Bath & Beyond (BBBY), Shire (SHPG), and Parker Hannifin (PH). INCREASED STAKES: Actavis (ACT), Amgen (AMGN), EQT (EQT), Sensata (ST), Coca-Cola Enterprises (CCE). DECREASED STAKES: Williams Cos (WMB), Ally Financial (ALLY), Cheniere Energy (LNG), YPF (YPF), and FedEx (FDX). LIQUIDATED STAKES: AIG (AIG), T-Mobile (TMUS), Rackspace (RAX), Hertz (HTZ), and Citrix Systems (CTXS).

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