GW Pharmaceuticals’s cannabidiol epilepsy drug ready for NDA filing

GW Pharmaceuticals plc (NASDAQ:GWPH, LON:GWP) said it was on track for an NDA (New Drug Application) filing for both its cannabis-derived Dravet Syndrome and Lennox-Gastaut Syndrome indications following positive Phase III trials.

“We believe that these Phase III data show that Epidiolex has the potential to provide a robust and clinically meaningful reduction in seizures in these highly treatment-resistant populations together with an acceptable safety and tolerability profile,” stated chief executive Justin Gover.

Last month, GW raised just over £200mln (US$273mln) from a follow-on offering.

“Our recent successful financing has provided GW with the necessary capital to move forward with confidence in preparing to execute a highly successful launch,” added Gover.

The group reported losses for the nine months ended June of £46.7mln (US$62.2mln) compared to £32.3mln reported last year. It said the loss reflected investment in the Phase III pivotal trials program.

It ended the period with £191.2mln

... read more at: http://www.proactiveinvestors.co.uk/companies/news/129158/gw-pharmaceuticals-s-cannabidiol-epilepsy-drug-ready-for-nda-filing-129158.html

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