GWPH is a UK-based biopharmaceutical company. It is devoted to the development and commercialization of cannabinoid prescription medicines.
The big attraction to GWPH stock is the company's late-stage marijuana-derived cannabidiol treatment, Epidiolex. The drug is aimed at treating Dravet's syndrome, a rare and severe form of childhood epilepsy.
Epidiolex was granted U.S. Food and Drug Administration Fast Track status on June 6, 2014. FDA Fast Track designation means a drug under review (Epidiolex) targets serious medical conditions and fulfills an unmet and urgent medical need. Typically, trial drugs granted Fast Track designation have greater access to the FDA for the purpose of accelerating the drug's development and FDA review.
The designation also implies a much quicker drug approval process when the drug is given the FDA's nod.
GWPH moved close to that nod in May.
That's when the company began pivotal phase 3 trial programs for Epidiolex in childhood epilepsy. GWPH expects trial slots to fill quickly. The company aims to report initial top-line data by the end of 2015.
GWPH's latest data, presented at the American Academy of Neurology in early April, reinforced the company's confidence in Epidiolex becoming an important advancement in the field of treatment-resistant epilepsy.
Alternative treatments are currently available for epilepsy, but their side effects have been described as "awful." The exception is GWPH's in-trial therapy.
The company plans to submit a new drug application (NDA) to the FDA in 2016. It continues to work on all the details needed for a successful commercial launch of Epidiolex.
Indeed, excitement of Epidiolex's potential helped GWPH successfully raise $179.2 million in a secondary stock offering on May 2.
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