GW Pharmaceuticals Jumps As DEA Moves Cannabis-Derived Drug To Low Risk Category

Shares of GW Pharmaceuticals jumped in late morning trading after the company said Epidiolex will be now classified as a Schedule V controlled substance, the lowest ranked class, instead of a Schedule I drug, which had been widely expected.

DEA RESCHEDULES EPIDIOLEX: GW Pharmaceuticals announced this morning, along with its U.S. subsidiary Greenwich Biosciences, that the U.S. Drug Enforcement Administration has rescheduled the company’s Epidiolex oral solution. Instead of a Schedule I drug, the DEA will classify the cannabis-derived drug as a Schedule V controlled substance, the lowest restriction classification.

WHAT’S NOTABLE: Epidiolex was approved in June by the U.S. Food and Drug Administration to treat patients two years and older with Dravet Syndrome and Lennox-Gastaut Syndrome, two rare forms of epilepsy that emerge during childhood. Epidiolex is derived from cannabidiol, or CBD, a molecule contained in the marijuana plant. Marijuana is considered a Schedule I drug, which are drugs seen to have high abuse potential, no medical use and severe safety concerns. Schedule V drugs, meanwhile, including some cough medicines containing codeine, have a currently accepted medical use in treatment.

EXECUTIVE COMMENTARY: In a statement, GW Pharmaceuticals CEO Justin Gover said he is “pleased” that the DEA has placed Epidiolex in the lowest restriction schedule, “because it will help ensure that patients with LGS and Dravet syndrome, two of the most debilitating forms of epilepsy, can access this important new treatment option through their physicians.” Gover said the company will “work hard” to make Epidiolex available within the next six weeks.

ANALYST COMMENTARY: Cantor Fitzgerald analyst Elemer Piros said the DEA’s rescheduling of Epidiolex is the “best possible outcome” for GW Pharmaceuticals, as the company has now checked off the last box to prepare for U.S launch of the drug within the next six weeks. The analyst reiterated an Overweight rating and $211 price target.