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News Breaks
March 13, 2014
07:13 EDTATRS, ACTAntares Pharma reports Q4 EPS (4c), consensus (5c)
Antares Pharma (ATRS) reports Q4 revenue $4.75M, consensus $6.15M. The company said "Product revenue decreased in Q4 to $0.9M. The decrease in product revenues in Q4 was primarily due to a decrease in sales of oxybutynin gel 3% product to Actavis (ACT), as Actavis assumed all manufacturing of Gelnique 3% in 1Q13, as contracted.
News For ATRS;ACT From The Last 14 Days
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January 27, 2015
17:04 EDTACTShire granted petitiion by U.S. Supreme Court
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January 26, 2015
17:34 EDTACTActavis registration statement for Allergan acquisition declared effective
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07:34 EDTACTActavis to acquire Auden Mckenzie for GBP306M accretive in FY15
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07:02 EDTATRSAntares says FDA issues complete response letter for Sumatriptan Injection ANDA
Antares Pharma announced that the U.S. Food and Drug Administration has issued a complete response letter regarding the Abbreviated New Drug Application for Sumatriptan Injection USP for the acute treatment of migraine. The complete response letter from the FDA provided revisions to labelling and cited minor deficiencies. If approved, Sumatriptan Injection USP would represent the Company’s first ANDA approval and second device approved from the VIBEX auto injector platform. As previously disclosed, Teva Pharmaceutical Industries, Ltd. would distribute the product and share the profits equally with Antares Pharma. Eamonn P. Hobbs, President and CEO, stated, “We are pleased with the feedback received from the FDA in the complete response letter. The FDA has outlined the steps necessary to support approval of the ANDA, and we plan to work closely with the Agency on a response.”
06:16 EDTATRSAntares Pharma announces complete response letter for Sumatriptan ANDA
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January 22, 2015
05:57 EDTACTActavis, Valeant raise prospects of more healthcare deals, Financial Times says
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January 21, 2015
12:30 EDTACTGlaxoSmithKline 'admired' by Pfizer CEO, FT reports
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07:22 EDTACTActavis price target raised to $330 from $280 at Deutsche Bank
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January 20, 2015
05:34 EDTACTActavis reports positive Phase III results for cariprazine
Gedeon Richter and Actavis announced positive results from a Phase III trial evaluating the efficacy and safety of cariprazine in the prevention of relapse in patients with schizophrenia. There were 101 patients randomized to cariprazine 3 to 9 mg per day and 99 randomized to placebo. The primary efficacy measure was time to first relapse during the double-blind period. There were 25 relapses in the cariprazine group versus 47 relapses in the placebo group. Treatment with cariprazine was associated with a 55% reduction in risk of relapse versus placebo.
January 16, 2015
10:20 EDTATRSAntares Pharma management to meet with JMP Securities
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January 14, 2015
18:18 EDTACTOn The Fly: After Hours Movers
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16:59 EDTACTGalena, Orexo AB receive "Paragraph IV" patent certification notice from Actavis
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