Shares of GW Pharmaceuticals PLC- ADR GWPH, a developer of cannabinoid prescription medicines, spiked by more than 10 percent Monday morning following the company's announcement that Epidiolex achieved a primary endpoint in a Phase 3 clinical study.
Epidiolex, GW Pharma's lead cannabinoid product candidate, is an oral pharmaceutical formulation of CBD, which is in development for the treatment of a number of rare childhood-onset epilepsy disorders.
GW announced in June positive results in the first pivotal Phase 3 trial of Epidiolex and now expects to submit a New Drug Application to the U.S. Food & Drug Administration in the first half of 2017.
Alan Brochstein, founder of 420 Investor, said GW Pharma's results marks "more good news" for the ongoing trial.
Specifically, he pointed out that the trial included a low dose and a high does, both of which were "very significant" with improved efficacy for the higher dose at a cost of slightly more adverse side effects.
"It should be very clear that Epidiolex is safe and effective after this third trial, the last of which will be included in the filing of the NDA for Epidiolex, which remains on track for H1-17," Brochstein added.
Brochstein also pointed out that Big Pharma is "starving for new products" and GW Pharma's Epidiolex "has the potential to be a blockbuster drug." As such, the topic of acquisition remains on the table. Although the expert isn't expecting GW Pharma to sell itself before Epidiolex receives final approval, he "can't rule out" a potential deal occurring in the interim.
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