GW Pharmaceuticals plc Reports First Quarter 2016 Financial Results

GW Pharmaceuticals plc (NASDAQ:GWPH, AIM:GWP, AIM:GW) reported its financial results for the first quarter ended 31 December 2015.
According to the company:

RECENT OPERATIONAL HIGHLIGHTS

• Epidiolex^® (CBD) childhood epilepsy program:
  • Company sponsored Phase 3 development programs in Dravet syndrome and Lennox-Gastaut syndrome (LGS)
    • First Phase 3 Dravet syndrome trial fully enrolled above original target sample size (120 randomized), data expected March 2016
    • Second Phase 3 Dravet syndrome trial ongoing, data expected H2 2016
    • Both LGS Phase 3 trials fully enrolled above original target sample sizes (171 for 2-arm, 225 for 3-arm randomized), data expected Q2 2016
    • 97% transition rate of eligible patients from Phase 3 trials to long term open label extension
    • NDA submission with FDA expected Q4 2016
    • Phase 3 Tuberous Sclerosis Complex trial due to commence Q1 2016
    • Additional clinical development for Epidiolex expected to commence in H2 2016
  • Expanded access program
    • Recent data update at the American Epilepsy Society December 2015 Annual Meeting showing promising safety and effectiveness consistent with prior updates
    • Over 375 children and young adults on treatment at 22 U.S. clinical sites
    • Over 900 children and young adults authorized for treatment by FDA under Expanded Access Treatment INDs and 6 U.S. State programs
• Advanced clinical programs in multiple cannabinoid pipeline product candidates:
  • THCV Phase 2 study in type-2 diabetes data expected Q2 2016
  • THC:CBD Phase 1b/2a study for the treatment of Recurrent Glioblastoma Multiforme (GBM) fully enrolled with data expected in mid-2016
    • Orphan Drug Designation granted from FDA and EMA
  • Sativex^® Phase 2 study in spasticity due to cerebral palsy ongoing with data expected H2 2016
  • CBDV Phase 2 partial-onset epilepsy study in adults ongoing. Part A complete and Part B underway with data expected around the end of 2016
  • Neonatal Hypoxic-Ischemic Encephalopathy (NHIE) intravenous CBD Phase 1 clinical program expected to commence in H2 2016
    • Orphan Drug and Fast Track Designations granted from FDA and EMA
  • Clinical trials within the field of autism spectrum disorders expected to commence in H2 2016
• Pre-clinical progress addressing a number of areas of unmet need including autism spectrum disorders, Duchenne muscular dystrophy, glioma, ovarian and pancreatic cancers

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