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February 8, 2013
07:34 EDTPOZNPOZEN presents PA32540 Phase 3 data
POZEN presented data from the combined results of two Phase 3 studies of PA32540, an antiplatelet therapy of enteric-coated and immediate-release omeprazole, in patients with previous cerebrovascular disease. These data were presented at the American Heart Association 2013 International Stroke Conference. According to the studies, in the post-hoc analysis of subjects with a history of transient ischemic attack or stroke, long-term treatment with PA32540, compared to EC-ASA, was associated with a significantly reduced rate of endoscopic gastroduodenal ulcers, and study discontinuation due to adverse pre-specified upper GI events. The incidence of adjudicated major adverse cardiac events was similar for PA32540 and EC-ASA. Key Findings of the Study: PA32540 is associated with a lower rate of endoscopic gastroduodenal mucosal injury with a similar cerebrovascular event profile as EC-ASA therapy; PA32540, a single tablet containing EC aspirin and IR omeprazole, has a lower rate of discontinuation and, hence, may improve long-term adherence to ASA therapy.
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December 17, 2014
09:22 EDTPOZNOn The Fly: Pre-market Movers
HIGHER: Auspex Pharmaceuticals (ASPX), up 83.1% after Phase 3 trial of SD-809 met primary efficacy endpoint... Volcano (VOLC), up 55.3% after Philips (PHG) announced it will acquire the company for $18.00 per share... Paramount Gold and Silver (PZG), up 35.9% after announcing a merger agreement with Coeur Mining... Cerus (CERS), up 17.8% after FDA approves Intercept Blood System... American Apparel (APP), up 15.5% after terminating Dov Charney for cause... TASER (TASR), up 6.1% after LAPD purchases 860 AXON body-worn video cameras... Idera Pharmaceuticals (IDRA), up 5.9% after being called a top 2015 small cap pick at Piper Jaffray... Kandi Technologies (KNDI), up 7.5% after selling 1,000 electric vehicles to Chengdu City... Stillwater Mining (SWC), up 2.7% after being upgraded to Buy from Neutral at Goldman. DOWN AFTER EARNINGS: FedEx (FDX), down 3.5%... Joy Global (JOY), down 1.7%. ALSO LOWER: POZEN (POZN), down 13.1% after receiving a second complete response letter from the FDA for Yosprala... Cliffs Natural (CLF), down 13.1% after price target cut to $1 from $10 at Credit Suisse... Coeur Mining (CDE), down 2.8% following merger agreement with Paramount Gold and Silver.
08:18 EDTPOZNPOZEN to hold a webcast
Management discusses receiving a second complete response letter from the FDA regarding new drug Yosprala in a webcast to be held on December 17 at 8:30 am. Webcast Link
06:34 EDTPOZNPOZEN's NDA for Yosprala candidate receives FDA letter on pending questions
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