GW Pharma (GWPH) Posts Q3 Loss of 6c/Share; THCV Phase 2 Missed Primary Endpoint in T2D
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GW Pharma (NASDAQ: GWPH) reported Q3 EPS of ($0.06), $1.15 better than the analyst estimate of ($1.21). Revenue for the quarter came in at $3.1 million versus the consensus estimate of $3.63 million.
RECENT OPERATIONAL HIGHLIGHTS
- Epidiolex® (CBD) orphan epilepsy program in Dravet syndrome, Lennox-Gastaut Syndrome (LGS), Tuberous Sclerosis Complex (TSC) and infantile spasms (IS)
- Phase 3 development programs:
- Positive results in first Phase 3 Dravet syndrome trial
- Positive results in first Phase 3 LGS trial
- Data presentations expected at upcoming American Epilepsy Society Annual Meeting in December
- Positive Dravet syndrome Pre-NDA meeting held with FDA
- NDA on track for H1 2017 submission for both Dravet and LGS indications
- Data from second LGS trial expected at end of Q3
- Second Phase 3 Dravet syndrome trial ongoing
- Phase 3 trial in TSC ongoing
- Phase 3 trial in IS to commence in Q4 2016
- Expanded access program and open label extension:
- Over 1,000 patients now on Epidiolex treatment under Expanded Access Treatment INDs, U.S. State programs, and open label extension trial
- Phase 3 development programs:
- Advanced clinical programs in multiple cannabinoid pipeline product candidates:
- CBDV Phase 2 partial-onset epilepsy study in adults ongoing. Part A complete and Part B underway with data expected H1 2017
- CBDV pre-clinical research ongoing within field of autism spectrum disorders. Initial open-label clinical evaluation expected to commence in H2 2016, with Phase 2 trials expected to commence in H1 2017
- Neonatal Hypoxic-Ischemic Encephalopathy (NHIE) intravenous CBD Phase 1 clinical program expected to commence in Q4 2016
- Orphan Drug and Fast Track Designations granted from FDA and EMA
- THC:CBD Phase 1b/2a study for the treatment of Recurrent Glioblastoma Multiforme (GBM) fully enrolled with data expected in Q4 2016
- Sativex® Phase 2 study in children with spasticity due to cerebral palsy fully enrolled with data expected Q4 2016
- THCV Phase 2 study in type 2 diabetes completed, primary endpoint not achieved
For earnings history and earnings-related data on GW Pharma (GWPH) click here.
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