GWPH - GW Pharmaceuticals

  • Ecco la 60° Edizione del settimanale "Le opportunità di Borsa" dedicato ai consulenti finanziari ed esperti di borsa.

    Questa settimana abbiamo assistito a nuovi record assoluti in Europa e a Wall Street. Il tutto, dopo una ottava che ha visto il susseguirsi di riunioni di banche centrali. Lunedì la Bank of Japan (BoJ) ha alzato i tassi per la prima volta dal 2007, mettendo fine all’era del costo del denaro negativo e al controllo della curva dei rendimenti. Mercoledì la Federal Reserve (Fed) ha confermato i tassi nel range 5,25%-5,50%, mentre i “dots”, le proiezioni dei funzionari sul costo del denaro, indicano sempre tre tagli nel corso del 2024. Il Fomc ha anche discusso in merito ad un possibile rallentamento del ritmo di riduzione del portafoglio titoli. Ieri la Bank of England (BoE) ha lasciato i tassi di interesse invariati al 5,25%. Per continuare a leggere visita il link

A me pare bella

nel riquadro il movimento fatto sulla precedente trimestrale, il 5 novembre i dati del terzo quarter GW Pharmaceuticals plc to Report Financial Results and Operational Progress for the Third Quarter Ending September 30, 2019 and Host Conference Call on November 5, 2019

tenete presente che il 23 Settembre la commissione europea ha approvato la commercializzazione del suo farmaco Epidiolex a base di CBD
European Commission approves Epidiolex marketing authorization, GW Pharmaceuticals says

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Crolla in after hours dopo aver battuo le stime

Shares Of This CBD Oil-Selling Biotech Crashed Despite Quarterly Beat

Shares Of This CBD Oil-Selling Biotech Crashed Despite Quarterly Beat
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ALLISON GATLIN5:07 PM ET
GW Pharmaceuticals stock crashed late Tuesday despite better-than-expected sales of its seizure treatment, a CBD oil dubbed Epidiolex.

In after-hours trading on the stock market today, shares of GW Pharmaceuticals (GWPH) tumbled 10.2%, near 121, in average volume. GW Pharmaceuticals stock lost 1% at the close, ending the regular session at 134.75.

The biotech company makes Epidiolex, the only Food and Drug Administration-approved drug derived directly from the cannabis plant. Epidiolex contains cannabidiol, or CBD, an ingredient of cannabis. Unlike tetrahydrocannabinol, or THC, CBD is non-psychoactive.

During the third quarter ended Sept. 30, the CBD oil brought in $86.1 million in sales. Third-quarter revenue of $91 million grew from $2.4 million in the year-ago period. That easily topped the forecast of analysts polled by Zacks Investment Research for $87 million.

"Receptivity to the introduction of this breakthrough treatment continues to be highly encouraging as a result of positive physician and patient experiences as well as strong payer coverage," Chief Executive Justin Gover said in a written statement.

CBD Oil Sales Grow To $188 Million
On a year-to-date basis, Epidiolex has generated $188 million in sales, the biotech company said in a news release. So far, more than 15,000 patients in the U.S. have been prescribed Epidiolex to help them control forms of seizures.

More than 3,000 physicians have prescribed the CBD oil since its launch. Roughly 93% of commercial, Medicaid and Medicare patients receive insurance coverage for Epidiolex.


Outside the U.S., Epidiolex recently gained approval under the slightly altered brand name Epidyolex. Now, the biotech company is launching the drug in France and Germany. The U.K. is expected to weigh in on the drug's cost effectiveness in the fourth quarter.

The biotech company also plans to launch Epidyolex in Spain and Italy in 2020.

Biotech Company Tests Additional Uses
Importantly, GW Pharmaceuticals is working to expand the uses for its CBD oil. Next month, the biotech company will unveil the results of an Epidiolex study in patients with tuberous sclerosis complex. In this genetic disorder, benign tumors grow throughout the body.

GW Pharmaceuticals is also recruiting patients with Rett syndrome for another study. Rett syndrome is a neurological disorder that mostly affects girls.

Also during the quarter, GW Pharmaceuticals reported a net loss of $13.8 million, a decline from a $79.9 million net loss in the year-earlier quarter.
 
UK Recommends NHS Reimburse GW Pharma'''s CBD-Based Epilepsy Drug

By J Rodrigo Safdiye.

GW Pharmaceuticals PLC- ADR (NASDAQ: GWPH) announced Sunday that two of its medicines have been recommended by the U.K.’s National Institute for Health and Care Excellence to receive routine reimbursement from the National Health Service.

What Happened

Epidiolex, known as Epidyolex in Europe, and Sativex were approved by the NHS for the treatment of epilepsy and multiple sclerosis, respectively.

Doctors will be able to prescribe Epidyolex, an oral CBD solution, for children with two types of severe epilepsy, Lennox Gastaut syndrome and Dravet syndrome.

Sativex is a mouth spray containing a mixture of THC and CBD.

Related Story: Exclusive: Leafly Launches Cannabis Lab Testing Certification Program

Why It’s Important

"This is a momentous occasion for U.K. patients and families who have waited for so many years for rigorously tested, evidenced and regulatory approved cannabis-based medicines to be reimbursed by the NHS," Chris Tovey, GW’s chief operating officer, said in a statement.

“This is proof that cannabis-based medicines can successfully go through extensive randomized placebo-controlled trials and a rigorous NICE evaluation process to reach patients. I am hugely proud of the entire GW team for achieving this milestone in the country where the company was founded and where both of these medicines were developed and are manufactured.”

GW Pharma shares were down 3.38% at $109.40 at the close Tuesday.
 
Dragonfly Doji

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messo un cip
possibile inversione, vediamo :rolleyes:
 
Greenwich Biosciences, a GW Pharmaceuticals Company, Presents New Data for EPIDIOLEX®

Greenwich Biosciences, a GW Pharmaceuticals Company, Presents New Data for EPIDIOLEX(R) (cannabidiol) in Patients with Tuberous Sclerosis Complex (TSC) at the American Epilepsy Society Annual Meeting | GW Pharmaceuticals


December 7, 2019

Study results showed EPIDIOLEX significantly reduced difficult-to-treat seizures associated with TSC and improved overall patient condition as reported by caregivers
CARLSBAD, Calif., Dec. 07, 2019 (GLOBE NEWSWIRE) -- GW Pharmaceuticals plc (Nasdaq: GWPH), the world leader in the science, development, and commercialization of cannabinoid prescription medicines, along with U.S. subsidiary Greenwich Biosciences, today presented new data from a Phase 3 clinical trial of EPIDIOLEX® (cannabidiol or CBD) oral solution, CV in tuberous sclerosis complex (TSC) at the American Epilepsy Society (AES) Annual Meeting. The study found that patients treated with EPIDIOLEX 25 mg/kg/day or 50 mg/kg/day experienced a significantly greater reduction in TSC-associated seizures (49% for 25 mg/kg/day and 48% for 50 mg/kg/day) compared to placebo (27%; p=0.0009 and p=0.0018, respectively).

“Epilepsy is the most common neurological feature of TSC,1,2,3 a rare and severe childhood-onset disease, and as many as two-thirds of patients experience treatment-resistant seizures,”4 said Elizabeth Thiele, M.D, Ph.D., director of pediatric epilepsy and director of The Carol and James Herscot Center for Tuberous Sclerosis Complex at Massachusetts General Hospital, professor of neurology at Harvard Medical School, Boston and lead investigator of the trial. “There is a significant need for new treatments to address TSC-related seizures and these positive results suggest patients may benefit from this pharmaceutical formulation of highly-purified CBD.”

New secondary endpoint data, presented for the first time at AES, showed that more patients on EPIDIOLEX experienced a 50% or greater reduction in seizures (36% for 25 mg/kg/day and 40% for 50 mg/kg/day) compared to placebo (22%; p=0.0692 and p=0.0245, respectively). Additionally, 48% of patients taking either dose of EPIDIOLEX in the study experienced a greater reduction in total seizure frequency compared to placebo (27%; p=0.0013 and p=0.0018, respectively). Caregivers and patients also reported overall improvement with EPIDIOLEX in 69% of patients on 25 mg/kg/day and 62% of patients on 50 mg/kg/day compared to 39% on placebo (p=0.0074 and p=0.0580, respectively). Additional analysis showed that patients taking EPIDIOLEX in the study experienced a greater reduction in composite focal seizures (52% for 25 mg/kg/day and 50% for 50 mg/kg/day) compared to placebo (32%; p=0.0076 and p=0.0116, respectively).

“We are pleased to present these results which demonstrate the potential of EPIDIOLEX to reduce both focal and generalized seizures associated with TSC,” said Justin Gover, CEO, GW Pharmaceuticals. “This is promising news for patients and clinicians, and we remain committed to helping those suffering from seizures associated with this difficult-to-treat disease. We look forward to submitting an sNDA to the FDA soon, with the goal of expanding the EPIDIOLEX product label in 2020.”

The safety profile observed in the study was generally consistent with findings from previous studies. Adverse events (AEs) occurred in 93% of the 25 mg/kg/day group, 100% of the 50 mg/kg/day group and 95% of the placebo group. Both doses had an acceptable safety profile, with fewer AEs reported with 25 mg/kg/day than 50 mg/kg/day. The most common AEs were diarrhea, decreased appetite and somnolence. Eight patients on EPIDIOLEX 25 mg/kg/day, 10 on 50 mg/kg/day and 2 on placebo discontinued treatment due to an AE. Additionally, 13% of 25 mg/kg/day patients and 25% of 50 mg/kg/day patients experienced elevated liver enzymes; 79% of these patients were also taking the antiepileptic drug (AED) valproate. Elevations in ALT/AST resolved in all patients. There were no cases of Hy’s law observed and there were no deaths in the trial.
 
Cannabis-based drug for epilepsy to be fast-tracked into NHS | Society | The Guardian

Cannabis-based medicine is to be fast-tracked into the NHS, allowing thousands of people to be prescribed the drugs, including children with severe epilepsy.

Last month the NHS struck a deal with the manufacturer GW Pharmaceuticals to bring down the price of Epidiolex, which has been approved by the European medicines agency for use in children over the age of two who suffer from seizures associated with two rare and severe forms of epilepsy – Lennox-Gastaut syndrome (LGS) and Dravet syndrome.

NHS England has said it will speed the process through so that the drugs will be obtainable through doctors from 6 January.


Clinical trials have shown the treatment could reduce the number of seizures by up to 40% in some children when used in combination with another drug, Clobazam. It is estimated that 2,000 people a year could benefit.

The move will not end the calls for cannabis-based medicines to be made easily available on the NHS for people with other conditions. Sativex, GW’s cannabis-based medicine for multiple sclerosis, has been rejected because of its high price, to the dismay of patients and campaigners. Others have unsuccessfully campaigned for approval of cannabis medicines to relieve pain.

This year NHS England published a review of when it is safe and appropriate to consider prescribing unlicensed cannabis-based medicines. But it has become apparent that doctors are unwilling to take the responsibility without more evidence on the effects and safety.
 
Bel movimento oggi

ci si possono vedere diverse figure....

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Qui si vede meglio

da notare gli ottimi volumi al breakout della neck lineGWPH.jpg
 
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