Biotech

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

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

Click here to view the full press release.

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