GW Pharmaceuticals plc’s shares are riding high after the company reported third consecutive positive phase III data on its lead cannabinoid pipeline candidate, Epidiolex, so far this year. The company announced data from the second pivotal phase III study on Epidiolex, for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS).
Shares of the company touched a new 52-week high of $126.47 on Sep 26, eventually closing a little lower at $126.06. Overall, the stock has gained 17.2% on the news.
Epidiolex Meets Phase III Primary Endpoint
Results from the randomized, double-blind, placebo-controlled phase III study showed that Epidiolex, when added to the patients’ current anti-epileptic drugs treatment, met the primary endpoint for both dose levels (20mg/kg/day and 10mg/kg/day) with high statistical significance. Patients treated with 20mg/kg/day and 10mg/kg/day doses of Epidiolex witnessed median reductions of 42% and 37%, respectively, in monthly drop seizures, compared with a reduction of 17% in those on placebo, for both doses.
GW Pharma intends to present additional data in future publications and medical meetings.
We remind investors that GW Pharma had announced encouraging data from the first pivotal phase III study on Epidiolex for LGS in Jun 2016. Earlier in March, the company had also reported positive top-line data from the first pivotal phase III study that was conducted on the candidate for the treatment of Dravet syndrome. GW Pharma continues to enroll patients in the second phase III study, and anticipates data once completed.
We note that GW Pharma held a pre-new drug application (NDA) meeting with the FDA in Jul 2016. Per the company, guidance received during the meeting was positive, and therefore would enable the company to file a single NDA which would include phase III data from one Dravet syndrome study and two LGS studies. The company plans to submit the NDA to the FDA in the first half of fiscal 2017. If all goes well on the regulatory front, the company anticipates simultaneous approval for both the indications.
Meanwhile, Epidiolex is also being evaluated in a phase III study for the treatment of tuberous sclerosis complex. Further, the company expects to begin a phase III study on the candidate for the treatment of infantile spasms in the fourth quarter of fiscal 2016. Epidiolex enjoys Orphan Drug status in the U.S. for the treatment of LGS, Dravet syndrome, tuberous sclerosis complex and infantile spasms.
Rumors were doing the rounds recently that GW Pharma could be the next potential takeover target. With the company reporting another set of positive Epidiolex data, it has further become a promising acquisition target.
GW Pharma currently sports a Zacks Rank #1 (Strong Buy).
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