New User:

-or-
Username:
Password:
Forgot your password?

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
Sign up for a free trial to see the rest of the stories you've been missing.
July 23, 2015
14:01 EDTSHPGShire receives 'positive opinion' on Intuniv from CHMP
Shire announced that the Committee for Medicinal Products for Human Use has adopted a positive opinion recommending the approval of the once-daily, non-stimulant Intuniv, or guanfacine hydrochloride extended release, for the treatment of attention deficit/hyperactivity disorder in children and adolescents. The positive opinion is based on results from three Phase 3 pivotal studies investigating the short- and long-term safety and efficacy of Intuniv in children and adolescents. The European Commission will now consider the CHMP positive opinion in its decision of whether to grant marketing authorisation for Intuniv in Europe, said Shire.
07:25 EDTSHPGShire raises FY15 EPADS growth view to mid-to-high single digit percentage
Subscribe for More Information
07:22 EDTSHPGShire reports Q2 EPS $2.63, consensus $2.81
Subscribe for More Information

Sign up for a free trial to see the rest of the stories you've been missing.

I agree to the theflyonthewall.com disclaimer & terms of use