GW Pharmaceuticals Plc. (Nasdaq: GWPH) stock is up a whopping 70.36% in 2015. And GWPH stock still has legs to take shares higher.
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.
Investing in GWPH Stock Today
Money Morning Defense & Tech Specialist Michael A. Robinson pegged GWPH stock as a hot pot stock to watch in early 2014, as a flurry of marijuana-related stocks were on the rise.
[epom key="ddec3ef33420ef7c9964a4695c349764" redirect="" sourceid="" imported="false"]
"With its solid science, multiple uses for its main cannabis-based biotech product, and strong alliances with global drug leaders, GW Pharmaceuticals should leave investors richly rewarded," Robinson wrote March 27, 2014, when he cited GWPH as the best profit play in the sector. GWPH stock is up 105% since then.
In addition to Epidiolex, GW has a rich pipeline of other cannabinoid product candidates. Among them is Sativex, in phase 3 clinical development as a potential treatment of pain associated with advanced cancer. Additional treatments include compounds in phase 1 and 2 trials for glioma (a type of tumor that starts in the brain or the spine), ulcerative colitis, type 2 diabetes, and schizophrenia.
As Robinson noted, the company has partnerships with a couple of the world's largest publicly traded drug firms. GWPH stands to gain more than $300 million in revenue from those alliances alone.
Just a handful of analysts cover GWPH stock, according to data from The Wall Street Journal.
Among the five that do, four rate GWPH stock a "Buy." One maintains a "Hold." The median price target is $133.81. The high target is $151.
Piper Jaffray analyst Joshua Schimmer on April 22 reiterated a "Buy" rating on GWPH stock with a $147 price target. On April 14, Leerink Swann's Joseph Schwartz reaffirmed his "Buy" rating on shares. He has a price target of $120.
Both suggest 28% and 5% upside, respectively, from the $114.60 where GWPH stock is trading today.
Don't get embarrassed by not knowing which stocks are hot. Stay informed by following us on Twitter @moneymorning.
You Might Be Losing Money Every Day: Every investor is hard-wired to do three things that kill returns. Do you know how to avoid them? Find out what they are, plus the single best investment strategy for maximum gains, in our free guide: Make 2015 Your Wealthiest Year Yet...
Related Articles:
- The Wall Street Journal: GW Pharmaceuticals
- GWPH: About Us