GW Pharma gains on M&A rumor as it preps for FDA submission

marijuana leaf

GW Pharmaceuticals ($GWPH) gained about $500 million to hit $2.3 billion in market cap on rumors that it may soon be acquired. It was up by more than 20% on a report from Reuters that it has been approached by more than one potential acquirer and hired investment bank Morgan Stanley to manage the process.

The U.K.-based marijuana biopharma is on track to submit its lead pipeline candidate Epidiolex to the FDA for approval during the first half of next year to treat Dravet syndrome and Lennox-Gastaut syndrome (LSG). Both indications are rare forms of childhood-onset epilepsy.

“We believe the guidance received was both positive and supportive of the company's proposed filing strategy to submit a single NDA for both the Dravet syndrome and Lennox-Gastaut syndrome indications incorporating the single Dravet trial that has already reported results and the two LGS trials,” said GW CMO Stephen Wright on an earnings call last month.

He added, “Subject, of course to satisfactory FDA review, we now anticipate simultaneous submission and approval of both indications. The work on compiling the Epidiolex NDA is progressing on plan and we have been making very good progress towards completing all of the supporting studies for inclusion in the review.”

The drug is cannabidiol (CBD), one of many compounds in cannabis; this one in particular is absent the psychoactive effects that are typically associated with marijuana. Epidiolex has orphan drug designation from the FDA for Dravet syndrome, LGS, tuberous sclerosis complex and infantile spasms. It also has a fast-track designation from the agency.

Epidiolex is also in Phase II testing for epilepsy. CBD has been very high profile in the press as a potential treatment for seizures. Large-scale research on cannabinoids is difficult in the U.S. due to restrictions on the availability of marijuana for research use, since marijuana remains a highly limited, Schedule I drug, according to the U.S. Drug Enforcement Agency (DEA).

GW recently netted $273 million in a follow-on offering to enable it to prepare for the commercialization of Epidiolex, and the company says it’s already in discussions with U.S. payers based on the positive pivotal data. It’s in the process of developing outcomes research data to demonstrate the pharmaco-economic value of Epidiolex.