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GW Pharmaceuticals (GWPH) Q2 Loss Lower than Expected

GW Pharmaceuticals, Inc. GWPH reported a second-quarter fiscal 2016 (for the three months ended Mar 31, 2016) loss of $1.10 per share, narrower than the Zacks Consensus Estimate of a loss of $1.71. The reported loss, however, was much wider than the year-ago loss of 58 cents.

The company’s total revenue in the second quarter of fiscal 2016 was $3.81 million below the Zacks Consensus Estimate of $6.86 million.

Research & development expenses were up 67.4% year over year to almost $37 million due to investments in pipeline. Sales, general and administrative expenses decreased 14.5% year over year to $4.7 million.

The company’s key growth driver, Sativex, is approved outside the U.S. for the treatment of spasticity associated with multiple sclerosis. Sativex is currently being evaluated in a phase II study for spasticity due to cerebral palsy in children, with data expected in the fourth quarter of fiscal 2016.

GW Pharma’s pipeline includes interesting candidates like cannabidiol-based drug, Epidiolex. The company expects full publication of data from the first pivotal phase III study on Epidiolex for the treatment of patients suffering from Dravet syndrome also in the fourth quarter of fiscal 2016. In Mar 2016, the company had reported positive data from the first pivotal phase III study on Epidiolex for the treatment of patients with Dravet syndrome.

Meanwhile, GW Pharma is also conducting a second phase III study on Epidiolex for Dravet syndrome. Moreover, the company is conducting a global pivotal development program on Epidiolex for the treatment of Lennox-Gastaut syndrome. The company expects to report top-line data from the first phase III study next month; top-line data from the second study should be out in the third quarter of fiscal 2016.

GW Pharma plans to request a pre-new drug application (NDA) meeting with the FDA in mid-2016 to determine the regulatory path forward for Epidiolex. The company expects to file during the first half of 2017, subject to data from the Lennox-Gastaut syndrome studies. The NDA would include data supporting the approval of Epidiolex in both indications.

In Apr 2016, the company also initiated a phase III study on Epidiolex for the treatment of tuberous sclerosis complex. It received an orphan drug status from the FDA for this indication.

GW Pharma currently has a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include ANI Pharmaceuticals, Inc. ANIP, Retrophin, Inc. RTRX and Vital Therapies, Inc. VTL. All three stocks sport a Zacks Rank #1 (Strong Buy).

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