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Monday, May 6, 2019

GW Pharma scores another Phase 3 win for cannabinoid in rare form of epilepsy

GW Pharmaceuticals can now boast about its fifth straight successful Phase III trial for its cannabinoid drug Epidiolex.

Researchers for the biotech said Monday evening that the drug hit the primary endpoint on both doses tested, with seizure reductions of 48.6% and 47.5% from baseline for patients suffering from tuberous sclerosis complex — another rare form of childhood epilepsy — compared to 26.5% for placebo.
Shares of the biotech $GWPH popped about 6% after the news hit following the closing bell.
“With these data, we look forward to submitting an sNDA to the FDA in the fourth quarter with the goal of expanding the product label in 2020 to help the lives of patients suffering with TSC,” noted GW CEO Justin Gover in a prepared statement.
Already approved for Lennox-Gastaut syndrome and Dravet syndrome, GW Pharma has enjoyed considerable success fielding a drug that many analysts believe is a blockbuster in the making.
It still has a long way to go, though. Q1 sales hit $33.5 million.

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