GW Pharma beats by $0.04, beats on revs
- Reports Q1 (Dec) loss of $0.20 per share, excluding non-recurring items, $0.04 better than the S&P Capital IQ Consensus of ($0.24); revenues rose 67.5% year/year to $6.7 mln vs the $5.35 mln S&P Capital IQ Consensus.
Pipeline progress
- Sativex (nabiximols)
- FDA meeting in December resulted in regulatory pathway in the U.S.
- Initial U.S. target indication: Multiple Sclerosis spasticity
- Single Phase 3 pivotal study expect to commence in Q4 2019
- U.S. development and commercialization rights wholly owned by GW
- Over 10 placebo-controlled trials already completed in other indications, representing significant U.S. lifecycle management opportunities
- FDA meeting in December resulted in regulatory pathway in the U.S.
- CBDV
- Initial data from 5 patient expanded access program in patients with seizures and autism presented at American Epilepsy Society Annual Meeting suggest that CBDV is well tolerated and has potential as an AED/behavioral/cognitive medicine in the autism/epilepsy population
- Company sponsored IND open for 30-patient open label study in autism -
- Investigator-led 100 patient placebo-controlled trial in autism spectrum disorder to commence in H1 2019
- Open label study in Rett syndrome and seizures due to commence H1 2019
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