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News Breaks
October 7, 2013
10:38 EDTGWPHGW Pharmaceuticals soars after analyst nearly triples price target
Shares of Britain's GW Pharmaceuticals (GWPH) are jumping after a Lazard Capital analyst wrote that the company has one of the most compelling opportunities he's ever seen, and nearly tripled his price target on the stock. WHAT'S NEW: GW's CBD, a drug derived from the cannabis plant, has significantly helped some epilepsy patients to whom it has been administered, Lazard Capital analyst Joshua Schimmer wrote in a note to investors earlier today. Although not all the refractory childhood seizure patients who have taken the drug have improved, evidence suggests that the treatment does have "an antiseizure effect," the analyst believes after speaking with multiple experts. Moreover, "there is an enormous unmet need" for such an antiseizure treatment, and specialists appear to be extremely interested in CBD, Schimmer contended. He hiked his price target on GW to $65 from $22, and kept a Buy rating on the shares. TODAY'S PRICE ACTION: In mid-morning trading, GW rallied $5.95, or 24%, to $30.65.
News For GWPH From The Last 14 Days
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April 28, 2015
20:11 EDTGWPHGW Pharmaceuticals 1.6M share Secondary priced at $112.00
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April 27, 2015
18:56 EDTGWPHOn The Fly: After Hours Movers
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16:01 EDTGWPHGW Pharmaceuticals files to sell 1.25M ADSs
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07:08 EDTGWPHGW Pharmaceuticals announces patent allowance for Cannabidivarin in epilepsy
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April 24, 2015
07:13 EDTGWPHGW Pharmaceuticals receives ODD from FDA for CBD treatment of NHIE
GW Pharmaceuticals announced that the FDA has granted orphan drug designation for Cannabidiol, or CBD, for use in treating newborn children with neonatal hypoxic-ischemic encephalopathy, or NHIE. NHIE is acute or sub-acute brain injury due to asphyxia caused during the birth process and resulting from deprivation of oxygen during birth. The incidence of NHIE is 1.5 to 2.8 per 1,000 births in the United States, or, 6,500 to 12,000 cases per year. Of these, 35% are expected to die in early life and 30% may suffer from permanent disability. There are currently no FDA-approved medicines specifically indicated for NHIE. GW has developed an intravenous CBD formulation for use in this patient population. GW held a pre-IND meeting with the FDA and expects to submit an Investigational New Drug Application, or IND, in mid-2015 and to commence a Phase 1 trial in the second half of 2015. GW has been conducting pre-clinical research into the neuroprotective effects of CBD in animal models of NHIE since 2008. Publications from this research have shown that CBD reduces neurologic disability across a range of newborn animal models of brain hypoxia.
April 23, 2015
12:15 EDTGWPHGW Pharmaceuticals price target raised to $155 from $115 at BofA/Merrill
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09:03 EDTGWPHGW Pharmaceuticals granted orphan status in ischemic encephalopathy
The FDA granted GW Pharmaceuticals orphan status for its treatment of neonatal hypoxic ischemic encephalopathy.
08:02 EDTGWPHGW Pharmaceuticals price target raised to $135 from $120 at Leerink
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April 22, 2015
18:36 EDTGWPHGW Pharmaceuticals announces new physician reports of Epidiolex treatment effect
GW Pharmaceuticals announced new physician reports of clinical effect and safety associated with the Epidiolex expanded access program. These data were presented today by study authors at the American Academy of Neurology annual meeting in Washington DC. Physician reports of clinical effect and safety data have been presented on 137 children and young adults with treatment-resistant epilepsy who have been treated with GW's investigational cannabidiol, or CBD, product candidate, Epidiolex, for a period of at least 12 weeks. These data are from eleven hospital sites in the United States and were generated under expanded access Investigational New Drug applications, or INDs, authorized by the FDA. In addition, physician reports of safety data were presented on 213 patients. The expanded access program is comprised of clinical studies performed by individual physicians. FDA authorized expanded access programs facilitate access to investigational drugs for treatment use for patients with a serious or immediately life-threatening diseases or conditions who lack therapeutic alternatives. The patients included in the Epidiolex program had Dravet syndrome and Lennox-Gastaut syndrome, epilepsy types that can lead to intellectual disability and lifelong seizures, as well as 10 other types of severe epilepsy. Many of the 10 other types of epilepsy are extreme and rare, and several patients with these epilepsies have major congenital structural brain abnormalities.
April 21, 2015
07:14 EDTGWPHGW Pharmaceuticals initiates second Phase 3 trial for Epidiolex
GW Pharmaceuticals announced that it has initiated the second Phase 3 clinical trial of Epidiolex for the treatment of Dravet syndrome, a rare and catastrophic treatment-resistant form of childhood epilepsy. This follows GW's recent announcement of the commencement of the first Phase 3 clinical trial of Epidiolex in Dravet syndrome. GW expects to complete patient recruitment into this second trial in 2015 and to report top-line results in early 2016.

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