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GWPH

GW Pharmaceuticals

$118.33

3.02 (2.62%)

07:21
02/27/18
02/27
07:21
02/27/18
07:21

GW Pharmaceuticals receives orphan drug designation for cannabidiol treatment

GW Pharmaceuticals announced that the European Medicines Agency has granted orphan drug designation for cannabidiol for the treatment of tuberous sclerosis. GW is currently recruiting a Phase 3 clinical trial of Epidiolex as an adjunctive therapy for the treatment of seizures associated with TS, with data expected in the second half of 2018. Subject to positive results, GW expects to submit regulatory applications in 2019 for Epidiolex in TS in both the U.S. and Europe. TS is multisystem, genetic disease that causes benign tumors to grow in the brain and on other vital organs. TS can be life threatening in patients with severe symptoms, including drug resistant seizures and kidney failure. Up to 80 to 90% of individuals with TS will develop epilepsy during their lifetime, with onset typically in childhood. The seizures are often severe, and up to two-thirds of TS patients do not respond adequately to available medical therapies. There are significant co-morbidities associated with TS including cognitive impairment, autism spectrum disorders, developmental delay with severe learning disability and neurobehavioral disorders in individuals with TS. The EMA orphan designation is a status assigned to a medicine intended for use against a rare condition and allows a pharmaceutical company to benefit from incentives offered by the EU to develop a medicine for the treatment, prevention or diagnosis of a disease that is life-threatening or a chronically debilitating rare disease. These incentives can include reduced fees and protection from competition once the medicine is placed on the market. GW has already received orphan drug designation from the FDA for CBD in the treatment of TS.

  • 27

    Jun

GWPH GW Pharmaceuticals
$118.33

3.02 (2.62%)

12/29/17
LEER
12/29/17
NO CHANGE
LEER
Outperform
GW filing acceptance, FDA panel in line with expectations, says Leerink
Leerink analyst Paul Matteis said the FDA accepting the Epidiolex new drug application and granting of priority review were in line with expectations given the three positive late-stage studies and the unmet need for the two rare orphan epilepsies. The analyst thinks an Advisory Committee was likely given that Epidiolex is a plant-derived cannabinoid drug seeking a primarily pediatric indication. Matteis yesterday reiterated an Overweight rating on shares of GW Pharmaceuticals.
01/23/18
LEER
01/23/18
NO CHANGE
Target $153
LEER
Outperform
Leerink cautiously optimistic ahead of GW Pharmaceuticals CBDV Phase 2 data
Leerink analyst Paul Matteis reiterates an Outperform rating on GW Pharmaceuticals, while lowering his price target on the shares to $153 from $154, ahead of CBDV Phase II data in partial-onset seizures in Q1. While he acknowledges that is difficult to garner conviction in the Phase 2, his analysis of pre-clinical results - compared side-by-side to cannabidiol - instills him with "cautious optimism" on the program, while he believes that the little credit priced into the stock for CBDV sets up an upside skewed risk/reward on the upcoming data readout this quarter.
02/06/18
CANT
02/06/18
NO CHANGE
Target $192
CANT
Overweight
GW Pharmaceuticals price target lowered to $192 from $208 at Cantor Fitzgerald
Cantor Fitzgerald analyst Elemer Piros lowered his price target for GW Pharmaceuticals to $192 following the company's Q1 financial results and recent equity raise. The analyst, however, believes the shares remain "significantly undervalued," based on his assessment of Epidiolex's opportunity in treating orphan pediatric epileptic conditions. He reiterates an Overweight rating on GW.
02/22/18
CANT
02/22/18
NO CHANGE
Target $192
CANT
Overweight
GW Pharmaceuticals shares could recover quickly, says Cantor Fitzgerald
Cantor Fitzgerald analyst Elemer Piros believes GW Pharmaceuticals shares could recover quickly from the selloff on the negative results with GWP42006 in adult patients with focal seizures. The analyst highlights the announcement of an advisory committee hearing for Epidiolex on April 18. The "clear near-term focus" is the successful commercialization of Epidiolex for pediatric pharmacoresistant seizures upon potential approval in the second half of 2018, Piros tells investors in a research note. He keeps an Overweight rating on GW shares with a $192 price target.

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