GW Pharmaceuticals reports Q2 EPS (2c) vs. 21 a year ago » 08:4008/1008/10/20
On August 6, GW…
On August 6, GW Pharmaceuticals reported Q2 revenue $121.3M vs. $72.0M a year ago. "We were pleased with the strength of U.S. Epidiolex sales in the second quarter in spite of the COVID-19 pandemic. Further, the recent approval and imminent launch of Epidiolex for the treatment of seizures associated with TSC provides a meaningful new opportunity to accelerate momentum through the second half of 2020 and beyond. We also continue to be excited about the potential of our product pipeline, in particular nabiximols, for which we recently outlined our accelerated US development strategy in the treatment of spasticity in patients with MS and other conditions. We look forward to commencing the nabiximols Phase 3 program as well as multiple other pipeline clinical trials in the second half of the year," stated Justin Gover, GW's CEO, on the date of the company's earnings release.
GW Pharmaceuticals price target lowered to $155 from $160 at Guggenheim » 08:3808/1008/10/20
Guggenheim analyst Yatin…
Guggenheim analyst Yatin Suneja lowered the firm's price target on GW Pharmaceuticals to $155 from $160 and keeps a Buy rating on the shares following last week's Q2 earnings report. The analyst sees modest q/q growth in 2H20.
|Over a week ago|
GW Pharmaceuticals price target raised to $183 from $166 at Oppenheimer » 07:3708/0408/04/20
Oppenheimer analyst Francois Brisebois raised the firm's price target on GW Pharmaceuticals to $183 from $166 and keeps an Outperform rating on the shares. The analyst notes that the company recently announced that the FDA has approved Epidiolex oral solution to treat seizures associated with tuberous sclerosis complex in patients 1 year or older. Additionally, Brisebois were particularly encouraged to learn that this age range also now includes LGS or Dravet syndrome patients. Given two-thirds of patients with TSC developing treatment-resistant epilepsy, he believes Epidiolex can fulfill another unmet medical need and expects rapid coverage.
GW Pharmaceuticals announces FDA approval for EPIDIOLEX oral solution » 07:0608/0308/03/20
GW Pharmaceuticals announced the U.S. Food and Drug Administration has approved EPIDIOLEX oral solution to treat seizures associated with tuberous sclerosis complex in patients one year of age and older. Along with this new indication, the age range has been expanded to include patients one year of age and older who experience seizures associated with Lennox-Gastaut syndrome or Dravet syndrome. TSC is a rare disease that causes benign tumors to grow in vital organs of the body and is a leading cause of genetic epilepsy. EPIDIOLEX, the first plant-derived cannabinoid prescription medicine and the only FDA-approved form of cannabidiol, was initially approved by the FDA in June 2018 for the treatment of seizures associated with LGS or Dravet syndrome in patients two years of age and older. GW has also received approval for this medicine in the European Union under the tradename EPIDYOLEX and a TSC EMA submission is currently under review. The Company anticipates most payers will quickly update their EPIDIOLEX coverage policies to include TSC at access levels similar to that of LGS and Dravet syndrome. FDA approval includes a recommended maintenance dose of 25 mg/kg/day for TSC patients, which is supported by data from a Phase 3 safety and efficacy study evaluating 25 mg/kg/day of EPIDIOLEX. The study met its primary endpoint, which was the reduction in seizure frequency compared to baseline of Epidiolex vs placebo, with seizure reduction of 48 percent in patients taking Epidiolex 25 mg/kg/day compared with 24 percent for placebo. All key secondary endpoints were supportive of the effects on the primary endpoint. The most common adverse events in those receiving EPIDIOLEX in the study included diarrhea; transaminase elevations; decreased appetite; somnolence; pyrexia; and vomiting. The safety profile observed in this study was generally comparable to that observed in prior studies of Epidiolex.
GW Pharmaceuticals price target raised to $165 from $160 at Cantor Fitzgerald » 07:0108/0308/03/20
Cantor Fitzgerald analyst…
Cantor Fitzgerald analyst Charles Duncan raised the firm's price target on GW Pharmaceuticals to $165 from $160 and keeps an Overweight rating on the shares following the announcement that the sNDA for Epidiolex was approved by the FDA for the treatment of seizures associated with tuberous sclerosis complex, or TSC, in patients over 1 year old. Duncan believes that as Epidiolex is the only FDA-approved CBD-containing therapeutic, the TSC review process reinforces the scientific/clinical rigor that the agency will rely on for any future product candidates in the class.
FDA PDUFA Date for GW Pharmaceuticals Epidiolex is July 31, 2020 10:1007/3107/31/20
Fly Intel: Top five analyst downgrades » 10:1007/1507/15/20
WM, AXP, GWPH, WING, MRVL
Catch up on today's…
Catch up on today's top five analyst downgrades with this list compiled by The Fly: 1. Waste Management (WM) downgraded to Neutral from Outperformer at CIBC. 2. American Express (AXP) downgraded to Underweight from Neutral at JPMorgan with analyst Richard Shane saying the company's "spend-driven model" is likely to remain pressured as high-income consumers reduce discretionary and leisure travel spend and corporate budgets remain pressured into the first half of 2021. 3. GW Pharmaceuticals (GWPH) downgraded to Hold from Buy at Stifel with analyst Paul Matteis saying while he sees the company's Q2 beating consensus, he believes "conservative physician expectations for Epidiolex use in 'off-label' refractory epilepsy" deviates significantly from the bull case and leads to a change in his rating and price target. 4. Wingstop (WING) downgraded to Neutral from Buy at Northcoast. 5. Marvell (MRVL) downgraded to Equal Weight from Overweight at Wells Fargo with analyst Gary Mobley saying with the shares up 40% year-to-date, the company's "margin for error is small." This list is just a portion of The Fly's full analyst coverage. To see The Fly's full Street Research coverage, click here.
|Over a month ago|
GW Pharmaceuticals downgraded to Hold from Buy at Stifel » 17:3707/1407/14/20
Stifel analyst Paul…
Stifel analyst Paul Matteis downgraded GW Pharmaceuticals to Hold from Buy with a price target of $140, down from $150. While the analyst sees the company's Q2 beating consensus, he believes "conservative physician expectations for Epidiolex use in 'off-label' refractory epilepsy" deviates significantly from the bull case and leads to a change in his rating and price target.
GW Pharmaceuticals price target raised to $275 from $250 at Evercore ISI » 12:5206/3006/30/20
Evercore ISI analyst…
Evercore ISI analyst Joshua Schimmer raised the firm's price target on GW Pharmaceuticals to $275 from $250 and keeps an Outperform rating on the shares after the company announced its Phase 3 plan for nabiximols in multiple sclerosis spasticity.
GW Pharmaceuticals to hold a webcast » 09:2506/3006/30/20
Management discusses the…
Management discusses the Nabiximols U.S. development program and market opportunity on a webcast being held on June 30 at 10 am. Webcast Link