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GW Pharmaceuticals plc Reports First Quarter 2016 Financial Results
Feb. 10, 2016 02:59PM PST
Biotech InvestingGW 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