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News Breaks
June 6, 2014
05:19 EDTGWPHGW Pharmaceuticals receives Fast Track designation for Epidiolex
GW Pharmaceuticals announced that the FDA has granted Fast Track designation to GW's investigational cannabidiol product, Epidiolex, in the treatment of Dravet syndrome, a rare and catastrophic treatment-resistant form of childhood epilepsy. In addition to Dravet syndrome, GW plans to conduct a clinical development program for Epidiolex in the treatment of Lennox-Gastaut syndrome. Following receipt earlier in 2014 of orphan drug designation by the FDA in LGS, GW expects to hold a pre-IND meeting with the FDA for Epidiolex in the treatment of LGS in mid-2014, and expects to conduct two Phase 3 trials in LGS during 2015.
News For GWPH From The Last 14 Days
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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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April 13, 2015
16:09 EDTGWPHGW Pharmaceuticals notes new Epidiolex data released by AAN
GW Pharmaceuticals noted that the American Academy of Neurology, or AAN, issued a press release today on GW's investigational medicine, Epidiolex. Data in the AAN release are from physician-led FDA authorized Epidiolex "expanded access" programs for children and young adults with treatment-resistant epilepsy that have exhausted available treatment options. The data provide treatment effect information on a total of 137 patients who have at least 12 weeks of Epidiolex exposure. Safety data is provided on 213 patients, representing these 137 patients plus additional patients still in their first 12 weeks of treatment. Additional data will be presented in a poster at the AAN Annual Meeting on 22 April at 6.15pm EDT, at which time GW will make an additional disclosure.

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