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News Breaks
July 22, 2013
05:19 EDTGWPHGW Pharmaceuticals files new regulatory application to expand Sativex in France
GW Pharmaceuticals announced that it has submitted an application under the European Mutual Recognition Procedure, or MRP, seeking to expand the marketing authorization for Sativex into France for the treatment of spasticity due to Multiple Sclerosis. This new regulatory application follows a Decree signed by the French Minister of Health in June, which amended national legislation in France so as to permit a prescription cannabis-based medicine, subject to approval by ANSM, the French regulatory authority.
News For GWPH From The Last 14 Days
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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.
April 20, 2015
10:29 EDTGWPHFly Watch: Added data on marijuana-derived epilepsy drug coming this week
GW Pharmaceuticals (GWPH) is expected to report additional results of a Phase III trial of its Epidiolex drug at the American Academy of Neurology's annual meeting on April 22. BACKGROUND: Made from cannabidiol, a non-psychoactive compound in marijuana, Epidolex is being tested as a treatment for certain forms of childhood epilepsy. Some data from the study was released on April 13 by the American Academy of Neurology, or AAN. That data was from physician-led FDA authorized Epidiolex "expanded access" programs for children and young adults with treatment-resistant epilepsy that have exhausted available treatment options, GW Pharmaceuticals stated. ANALYST TAKE: The risk/reward ratio for GW's stock is positive heading into the release of additional data on April 22, Leerink analyst Paul Matteis wrote in a note to investors earlier today. Investors are likely focused on three data points within the additional information, namely response rate data, whether the media overall seizure reduction differs from an October trial report when it was 36%, and the degree to which seizure reductions are sustained beyond 12 weeks. Given the study's lack of a placebo arm, investors may be most focused on the seizure reductions, as this is seen as a good indication as to whether controlled Phase III studies will be successful, wrote Matteis. Experts say that Epidiolex may be used to treat additional types of epliepsy if the Phase III data is positive, given its efficacy in difficult to treat patients and its superior safety profile compared with other epilepsy treatments, the analyst stated. The data already released from the latest study showed a "much greater" magnitude of overall seizure reduction than in the October update and a "consistent, robust effect" in larger samples of pediatric epilepsy patients, wrote Matteis, who raised his estimates of Epidiolex peak market penetrations and raised his price target on the stock to $120 from $102 while keeping an Outperform rating on the shares. PRICE ACTION: Shares of GW Pharmaceuticals are down $2, or 1.75%, to %112 per share in early trading. The stock has gained about 65% over the last six months.
April 14, 2015
08:38 EDTGWPHGW Pharmaceuticals price target raised to $120 from $102 at Leerink
Leerink analyst Paul Matteis raised his price target for shares of GW Pharmaceuticals to $120 after the American Academy of Neurology disclosed updated Epidiolex data from 137 patients. Matteis calls the data better than expectations saying they showed a "much greater" magnitude of overall seizure reduction than in the October update and a "consistent, robust effect" in larger samples of Dravet and Lennox Gastaut patients. He now assumes higher Epidiolex peak market penetrations and more use in the broader refractory pediatric epilepsy population. The analyst reiterates an Outperform rating on GW Pharmaceuticals. The stock closed yesterday at $96.18 and is trading up $7.87 to $104.05 in premarket trading.
07:25 EDTGWPHGW Pharmaceuticals undervalued based on Epidiolex potential, says Cowen
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