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Stock Market & Financial Investment News

News Breaks
January 10, 2014
10:20 EDTCHTP, SHPGChelsea 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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January 30, 2015
18:27 EDTSHPGShire announces FDA approval of Vyvanse
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January 27, 2015
17:04 EDTSHPGShire granted petitiion by U.S. Supreme Court
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January 26, 2015
08:21 EDTSHPGShire the 'real winner' after NPS gets approval for Natpara, says Janney Capital
Janney Capital said NPS Pharmaceuticals' (NPSP) getting FDA approval for its second marketed product, Natpara, is a positive for NPS, but that the "real winner" is Shire (SHPG), noting that the company had no stipulations dependent on Natpara approval in its deal to buy NPS. The firm expects the acquisition to move forward as planned and maintains its Neutral rating on NPS shares.
07:27 EDTSHPGShire price target raised to $263 from $247 at Jefferies
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05:26 EDTSHPGShire SHP609 receives FDA fast track designation
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January 25, 2015
12:30 EDTSHPGShire comments on press release from NPS Pharma on Natpara approval
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January 22, 2015
05:27 EDTSHPGShire reports positive response from European DCP for Elvanse Adult
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January 20, 2015
14:06 EDTSHPGCitizens, Keysight identified as long positions by Einhorn
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08:10 EDTSHPGShire price target raised to $247 from $228 at Jefferies
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