Why GW Pharmaceuticals Could Be an FDA First

Health and Healthcare

Published: April 17, 2018 2:00 pm

Last Updated: January 12, 2020 12:52 am

Shares of GW Pharmaceuticals PLC (NASDAQ: GWPH) made a solid gain on Tuesday after the U.S. Food and Drug Administration (FDA) released some briefing documents pertaining to an upcoming approval meeting. Needless to say, investors are taking this as a positive sign.

The meeting on April 19, 2018, will be reviewing Epidiolex, GW Pharma’s lead cannabinoid product candidate and a proprietary oral solution of pure plant-derived cannabidiol (CBD). The focus is on severe, early-onset, treatment-resistant epilepsy syndromes.

Many believed that being cannabis-derived would be an obstacle to Epidiolex’s regulatory approval, but that doesn’t seem to be the case. The FDA briefing did not raise any issues regarding the CBD, citing that it “has a negligible abuse potential.”

It’s worth pointing out that if approved, this would be the first cannabis-derived drug in the United States.

According to the document, the FDA drew the conclusion that:

The safety and tolerability profile of CBD-OS is predictable, and the potential risks are manageable through the proposed label and medication guide …

Overall, CBD-OS provides a positive benefit-risk for patients with drug-resistant Lennox-Gastaut syndrome (LGS) or Dravet syndrome (DS) and can satisfy an unmet need by providing an additional treatment option to reduce the number of seizures in LGS and the first indicated treatment option for DS.

Keep in mind that although this briefing is positive, the FDA could still side against it. Nothing is decided yet.

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Excluding Tuesday’s move, GW Pharma had underperformed the broad markets, with its stock up only 3% in the past 52 weeks. In just 2018 alone, the stock is down nearly 9%.

Shares of GW Pharma were last seen up over 10% at $133.33, with a consensus analyst price target of $151.29 and a 52-week range of $92.65 to $143.37.

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