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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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February 4, 2016
16:00 EDTSHPGShire's NDA for lifitegrast for dry eye resubmssion acknowledged by FDA
Shire announced that the FDA has acknowledged receipt of the resubmission of the New Drug Application for lifitegrast for the treatment of signs and symptoms of dry eye disease in adults. Shire resubmitted the NDA in response to the complete response letter received from the FDA on October 16, 2015 that requested an additional clinical study and more information related to product quality. The FDA determined that the submission is a complete response and has assigned a 6-month review period for the NDA and a Prescription Drug User Fee Act goal date of July 22.
February 3, 2016
08:07 EDTSHPGMedgenics names Brian Piper to succeed John Leaman as CFO
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February 2, 2016
09:46 EDTSHPGIntercept rumored to draw interest from many suitors, Daily Mail says
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January 28, 2016
10:05 EDTSHPGHigh option volume stocks
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January 25, 2016
07:02 EDTSHPGShire resubmits NDA for lifitegrast to FDA
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