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News Breaks
March 17, 2014
05:34 EDTGWPHGW Pharmaceuticals provides update on cannabinoid pipeline
GW Pharmaceuticals provided an update on the company's cannabinoid pipeline. GW has completed a Phase 1 clinical trial of GWP42006 to treat epilepsy. CBDV was well tolerated even at the highest tested dose and no significant side effects were observed. There were no serious or severe adverse events, nor any withdrawals due to adverse events, and all mild adverse events resolved on treatment. CBDV has shown the ability to treat seizures in pre-clinical models of epilepsy with significantly fewer side effects than currently approved anti-epileptic drugs1. CBDV also appears to employ a different mechanism of action to currently available anti-epileptic treatments. GW expects to commence a Phase 2 study of CBDV in patients with epilepsy later in 2014, using the doses identified as appropriate in this Phase 1 study. GW also announced that the Intellectual Property Office in the United Kingdom has granted a patent for the use of CBDV in the treatment of epilepsy, patent number GB2479153B. This same patent is currently in prosecution with the USPTO. GW has commenced a 12-week randomized, double blind, placebo controlled Phase 2b study of GWP42004 to treat Type 2 diabetes. The primary objective of this study is to compare the change in glycemic control in participants with Type 2 diabetes when treated with one of three doses of GWP42004 or placebo as add-on therapy to metformin with the primary endpoint being change from baseline to the end of treatment in mean glycosylated haemoglobin A1c level. The safety and tolerability of GWP42004 compared with placebo will also be assessed. This study is expected to enroll approximately 200 patients with an estimated completion date of the second half of 2015. GW has commenced a Phase 2a trial using GWP42003 to treat schizophrenia. GWP42003 has shown notable anti-psychotic effects in accepted pre-clinical models of schizophrenia and importantly has also demonstrated the ability to reduce the characteristic movement disorders induced by currently available anti-psychotic agents. The mechanism of GWP42003 does not appear to rely on the D2 receptor augmentation of standard antipsychotics and therefore has the potential to offer a novel treatment option in this therapeutic area.
News For GWPH From The Last 14 Days
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October 22, 2014
09:21 EDTGWPHOn The Fly: Pre-market Movers
UP AFTER EARNINGS: Dow Chemical (DOW), up 3.7%... iRobot (IRBT), up 12%... Six Flags (SIX), up 13%... GlaxoSmithKline (GSK), up 2%... Broadcom (BRCM), up 7%... Boston Scientific (BSX), up 4.3%... Abbott (ABT), up 1.8%... Yahoo! (YHOO), up 6%. ALSO HIGHER: Blue Earth (BBLU), up 26.4% after CEO says statements in Seeking Alpha blog are "false and misleading."... GW Pharmaceuticals (GWPH), up 5.4% after Epidiolex receives orphan designation from EMA. DOWN AFTER EARNINGS: 3D Systems (DDD), down 15%... Biogen (BIIB), down 7%... Lumber Liquidators (LL), down 13.4%... Norfolk Southern (NSC), down 3%... Angie's List (ANGI), down 8.8%. ALSO LOWER: Nanosphere (NSPH), down 33% after filing secondary, reporting preliminary Q3 revenue... Himax Technologies (HIMX), down 16% after announcing that Google (GOOG) will not exercise an additional investment option in the company... Cree (CREE), down 10.5%, downgraded at DA Davidson and Canaccord following the company's Q1 earnings results... Ocwen Financial (OCN), down 7% after downgraded to Hold at Evercore, downgraded to Neutral at BofA Merrill Lynch... VMware (VMW), down 7.8%, downgraded at Nomura and Raymond James following the company's Q3 results.
05:26 EDTGWPHGW Pharmaceuticals Epidiolex receives orphan designation from EMA
GW Pharmaceuticals announced that the European Medicines Agency, or EMA, has granted orphan designation to GW's investigational product Epidiolex in the treatment of Dravet syndrome, a rare and catastrophic treatment-resistant form of childhood epilepsy. In addition to this orphan designation by the EMA, GW has been granted Fast Track designation by the FDA for Epidiolex in the treatment of Dravet syndrome as well as orphan designations in both Dravet syndrome and Lennox-Gastaut syndrome, or LGS. GW is about to commence a full clinical development program for Epidiolex in the treatment of both Dravet syndrome and LGS, working with leading pediatric epilepsy specialists across the U.S. The first Phase 2/3 clinical trial is due to commence in the coming weeks.
October 14, 2014
18:20 EDTGWPHOn The Fly: After Hours Movers
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17:26 EDTGWPHGW Pharmaceuticals CEO says market for Epidiolex may be expanded over time
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14:55 EDTGWPHGW Pharma analyst day positive, reason for sell-off unclear, says Piper Jaffray
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08:07 EDTGWPHGW Pharmaceuticals data should 'silence the doubters,' says Piper Jaffray
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07:15 EDTGWPHGW Pharmaceuticals says Epidiolex physician reports show signals of efficacy
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07:11 EDTGWPHGW Pharmaceuticals announces preliminary topline results of Phase 2a trial
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06:38 EDTGWPHGW Pharmaceuticals to host research and development day
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