: Plan to sale options between Dez.16 and Jan.17
Zitat:"Mr Gover's plan provides for the exercise and sale of options over up to 372,823 Ordinary 0.1p Shares (equivalent to 31,068 American Depository Shares), between 9 December 2016 and 1 April 2017 in order to avoid otherwise adverse personal taxation implications of non-exercise of these options........Following exercise of these options, Mr Gover will continue to hold 1,057,293 options over Ordinary Shares (equivalent to 88,107 ADSs) and will continue to be the beneficial owner of an additional 2,513,759 Ordinary Shares (equivalent to 209,479 ADSs). " ENDE Zitat Source:http://ir.gwpharm.com/...m?filingID=1144204-16-127350&CIK=1351288
Angehängte Grafik: gwph_pipeline.jpg (verkleinert auf 84%)
: Epidiolex significantly reduced seizure frequency
Zitat:".. formulation of cannabidiol significantly reduced convulsive seizure frequency in children on multiple anti-epileptic drugs with poor seizure control ? Lead study author and director of the Comprehensive Epilepsy Center at NYU Langone Medical Center ;CEO, GW Pharmaceuticals/Greenwich Biosciences...? First well-controlled clinical study of cannabidiol in Dravet syndrome, a rare, severe type of epilepsy with no FDA-approved treatments ? " ENDE Zitat Source:http://www.otcmarkets.com/stock/GWPH/news https://www.stockwatch.com/News/...70524&symbol=GWPH®ion=U
schon mal bei Veritas Pharma vorbeigeschaut? Ähnliches Geschäftsmodell wie GW nur sehr neu und daher ist die Aktie gefühlt extrem unterbewertet. Macht einen guten Eindruck, zumindest vom Webauftritt und zu findenden Infos.
Zitat:"GW Pharmaceuticals plc (Nasdaq:GWPH) (?GW? or ?the Company?), a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, today announces the termination of its previous license agreement with Otsuka Pharmaceutical Co., Ltd. in relation to Sativex® (nabiximols) in the U.S. As a result, GW has now reacquired full ownership of the development and commercialization rights to the product in the U.S. market without making any upfront payment to Otsuka. ...." ENDE Zitat
Fazit: .. (rein subjektiv - keine Aufforderung zu jegwelchem Handeln...) wer jedoch an Sativex und der medizinischen Grundlage von Cannabinoiden und den daraus resultierenden Chancen für GW Pharmaceuticals glaubt, kann sich bei Interesse ggf. mal mein Wiki ansehen,... mit 46% Gesamtgewichtung bei GW Pharmaceuticals ADR? ist dieses jedoch als hochspekulativ zu werten! Cannabinoide sind künftig unter Umständen eine alternative Möglichkeit, bei der Reduzierung von Spasmen, sowie der Linderung und medizinischen Unterstützung bei Multiple Sklerose. Das "Cannabis & Cannabinoids Industryr" Wikifolio, soll am künftigen Erfolg von Sativex und einem Wertzuwachs des Unternehmens versuchen zu partizipieren....
: GWPH submitted MarketingAuthorisationApp EMA
Zitat:"...today announced it has submitted its Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for Epidiolex® (cannabidiol or CBD) as adjunctive treatment for seizures associated with Lennox-Gastaut syndrome (LGS) and Dravet syndrome, two highly treatment-resistant forms of childhood-onset epilepsy. GW has received Orphan Designations from the EMA for Epidiolex for the treatment of LGS, Dravet syndrome, and recently, West syndrome and Tuberous Sclerosis Complex. In October 2017, GW completed the submission of its rolling Epidiolex New Drug Application (NDA) to the United States Food and Drug Administration (FDA), also for seizures associated with LGS and Dravet syndrome. This NDA has been accepted by the FDA for Priority Review....."This MAA submission marks another major milestone for the Epidiolex program and is an important next step toward providing this potential new treatment option globally," stated Justin Gover, CEO of GW Pharmaceuticals...." ENDE Zitat Quelle:https://www.stockwatch.com/News/...71229&symbol=GWPH®ion=U
: 5 new Epidiolex Patents - expire in 2035
Zitat:"...GW Pharmaceuticals Announces Receipt of Notices of Allowance by the United States Patent and Trademark Office (USPTO) for Five New Epidiolex ® (cannabidiol) Patents...... Calif., March 13, 2018 (GLOBE NEWSWIRE) -- GW Pharmaceuticals plc (Nasdaq:GWPH) (?GW,? ?the Company? or ?the Group?), a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, along with its U.S. subsidiary Greenwich Biosciences, today announced receipt of Notices of Allowance for five new Epidiolex® patent applications that will be listed in the Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book) if the NDA for Epidiolex is approved. Once issued, these patents are set to expire in 2035. One or more patents may be eligible for additional patent term through patent term adjustment and/or regulatory excl...?The allowance of these important patent applications confirms GW?s innovative science and........... leadership in developing cannabinoid-based medicines and provides meaningful additional exclusivity for Epidiolex,? stated Justin Gover, GW?s Chief Executive Officer. ?We have numerous additional patent applications ....................under prosecution at the USPTO and will continue to work to expand our patent portfolio as we innovate and develop new Epidiolex formulations and additional products......? ENDE Zitat
: Greenwich Bios. Announces iResult of FDA
Zitat:".... its U.S. subsidiary Greenwich Biosciences, today announced that the Peripheral and Central Nervous System Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) unanimously recommended supporting the approval of the New Drug Application (NDA) for the investigational cannabidiol oral solution (CBD), also known as Epidiolex®, for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) and Dravet syndrome in patients two years of age and older. If approved, Epidiolex would be the first pharmaceutical formulation of purified, plant-based CBD, a cannabinoid lacking the high associated with marijuana, and the first in a new category of anti-epileptic drugs (AEDs)...." ENDE Zitat Quelle:https://www.stockwatch.com/News/...80419&symbol=GWPH®ion=U
: Operational & Financial Highlights 3-Q.2018
Zitat:" OPERATIONAL HIGHLIGHTS
Epidiolex (cannabidiol) Regulatory: FDA approval for the treatment of seizures associated with LGS or Dravet syndrome Epidiolex rescheduling expected within 90 days of FDA approval European submission under review by the EMA with decision expected in Q1 2019 FDA issuance of a priority review voucher (PRV) for Epidiolex. Manufacturing Commercial product being manufactured and prepared for shipping to the U.S. Continued investment in expanded facilities to meet anticipated long-term demand Commercial: U.S. sales organization fully recruited comprising two national directors, eight regional managers plus 66 Neurology Account Managers Active engagement with U.S. payors ongoing with clinical presentations to plans that cover over 80% of covered lives in the U.S. U.S. supply chain platform in place which will employ a closed model distribution network of five Specialty Pharmacy Providers (SPP?s) Commercial footprint in place in 5 major European markets in readiness for 2019 European launches Epilepsy Clinical trials Three Phase 3 clinical trials published - two in The New England Journal of Medicine and one in The Lancet Phase 3 trial in Tuberous Sclerosis Complex ongoing with data expected H1 2019 Autism Decision to expand target indications for Epidiolex beyond epilepsy to autism. IND expected to be submitted for pivotal Rett Syndrome study in Q4 18. Expanded access program and open label extension: Over 2,000 patients now have been exposed to Epidiolex treatment Life-cycle management Several new formulations of CBD in development including modified oral solution, capsule and an intravenous formulation Exclusivity 7-year orphan exclusivity confirmed by FDA, 6-month pediatric extension expected Key favorable patent grants by USPTO related to the use of CBD in epilepsy, including claims for the treatment of relevant seizure types associated with LGS and Dravet syndrome, as well as the use of CBD with clobazam Patents align directly with new Epidiolex FDA label and to be listed in Orange Book Patent expiry dates to 2035 Additional patent applications under review and being filed as new data is generated Pipeline progress Sativex® (nabiximols) U.S. development and commercialization rights wholly owned by GW Initial U.S. target indication: Multiple Sclerosis spasticity. Three positive Phase 3 trials completed in Europe Plans to meet with FDA in H2 18 to determine MS spasticity regulatory pathway in the U.S. Over 20 placebo-controlled trials already completed in other indications, representing significant U.S. lifecycle management opportunities CBDV 10-patient investigator-initiated expanded access program for seizures associated with autism underway Investigator-led 100 patient placebo-controlled trial in autism spectrum disorder due to commence in Q3 18 Open label study in Rett syndrome and seizures due to commence Q3 18 CBD:THC in Glioblastoma Recent data presented from the Phase 2 study showed significant increase in median survival for patients taking CBD:THC of 662 days compared to 369 days on placebo Pivotal clinical development program plans under development Orphan Drug Designation from both FDA and EMA for CBD:THC to treat glioblastoma Neonatal Hypoxic-Ischemic Encephalopathy (NHIE) intravenous CBD program Phase 1 trial complete Orphan Drug and Fast Track Designations granted from FDA and EMA Phase 2 trial in planning
Cash and cash equivalents at 30 June 2018 of £334.0 million ($440.2 million) compared to £241.2 million as at 30 September 2017
Revenue for the nine months ended 30 June 2018 of £10.7 million ($14.2 million) compared to £6.1 million for the nine months ended 30 June 2017
Loss for the nine months ended 30 June 2018 of £136.7 million ($180.2 million) compared to £90.3 million for the nine months ended 30 June 2017... " ENDE ZItat
: DEA down-calssify GW Pharma´s Epidiolex ??
Zitat:"U.S. DEA to down-classify GW Pharma's Epidiolex; .....Sep. 19, 2018 1:04 PM ET|About: GW Pharmaceuticals plc (GWPH)|By: Douglas W. House, SA News Editor...GW Pharmaceuticals (GWPH +8%) is up on more than a 4x surge in volume on the heels of a report by Morgan Stanley's David Lebowitz (OVERWEIGHT/$197) saying the U.S. Drug Enforcement Administration (DEA) is expected to reclassify Epidiolex (cannabidiol) to allow for medicinal use....The medication, approved by the FDA about two months ago for severe forms of epilepsy, is currently categorized as Schedule I alongside heroin and cocaine.The revised classification, expected to occur in the next few days, will move Epidiolex to Schedule IV, the same class as Xanax, Ambien and Tramadol... "ENDE Zitat Quelle:https://seekingalpha.com/news/...w-pharmas-epidiolex-shares-8-percent https://www.gwpharm.com/about-us/news/...a-advisory-committee-meeting
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: Epidiolex transferred to Schedule V. by DEA
Zitat:"LONDON and CARLSBAD, Calif., Sept. 27, 2018 (GLOBE NEWSWIRE) -- GW Pharmaceuticals plc (Nasdaq: GWPH, ?GW,? ?the Company? or ?the Group?), a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, along with its U.S. subsidiary Greenwich Biosciences, announced today that EPIDIOLEX® (cannabidiol) oral solution has been transferred to Schedule V, the lowest restriction classification, by the U.S. Drug Enforcement Administration (DEA). EPIDIOLEX, which was approved by the U.S. Food and Drug Administration (FDA) on June 25, 2018 for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome in patients two years of age or older, is the first prescription pharmaceutical formulation of highly-purified, plant-derived cannabidiol (CBD), a cannabinoid lacking the high associated with marijuana, and the first in a new category of anti-epileptic drugs (AEDs)...." ENDE Zitat Quelle:https://www.stockwatch.com/News/...80927&symbol=GWPH®ion=U
: Results of completed Phase 3 Trials Epidiolex
Zitat:"GW Pharmaceuticals plc (Nasdaq: GWPH, ?GW,? ?the Company? or ?the Group?), the world leader in the development and commercialization of cannabinoid prescription medicines, along with its U.S. subsidiary Greenwich Biosciences, announced today that results from completed Phase 3 trials of EPIDIOLEX® (cannabidiol) oral solution CV, as well as new pre-clinical and Phase 1 cannabinoid research, will be presented at the American Epilepsy Society (AES) Annual Meeting, November 30-December 4, 2018, in New Orleans, Louisiana. EPIDIOLEX is FDA-approved and available by prescription in the U.S. for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome in patients two years of age and older...." ENDE Zitat Quelle:https://www.stockwatch.com/News/...81119&symbol=GWPH®ion=U
: Safety Information & Indications in EPIDIOLEX
Important Safety Information & Indications What is the Most Important Information I Should Know About EPIDIOLEX? Do not take if you are allergic to cannabidiol or any of the ingredients in EPIDIOLEX. EPIDIOLEX may cause liver problems. Your doctor may order blood tests to check your liver before you start taking EPIDIOLEX and during treatment. In some cases, EPIDIOLEX treatment may need to be stopped. Call your doctor right away if you start to have any of these signs and symptoms of liver problems during treatment with EPIDIOLEX:
loss of appetite, nausea, vomiting fever, feeling unwell, unusual tiredness yellowing of the skin or the whites of the eyes (jaundice) itching unusual darkening of the urine right upper stomach area pain or discomfort
EPIDIOLEX may cause you to feel sleepy, which may get better over time. Other medicines (e.g., clobazam) or alcohol may increase sleepiness. Do not drive, operate heavy machinery, or do other dangerous activities until you know how EPIDIOLEX affects you.
Like other antiepileptic drugs, EPIDIOLEX may cause suicidal thoughts or actions in a very small number of people, about 1 in 500.
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: positive top-line results Phase 3 clinical trial
Zitat:"CARLSBAD, Calif., May 06, 2019 (GLOBE NEWSWIRE) -- GW Pharmaceuticals plc and its U.S. subsidiary Greenwich Biosciences Inc. (NASDAQ: GWPH, GW, the Company or the Group), the world leader in the science, development, and commercialization of cannabinoid prescription medicines, today announced positive top-line results of a randomized, double-blind, placebo-controlled Phase 3 clinical trial of EPIDIOLEX® (cannabidiol or CBD) CV in the treatment of seizures associated with Tuberous Sclerosis Complex (TSC), a rare and severe form of childhood-onset epilepsy. In this trial, EPIDIOLEX met its primary endpoint, which was the reduction in seizure frequency compared to baseline of the Epidiolex 25 mg/kg/day dose group vs placebo (p=0.0009). Results for both the 25 and 50 mg/kg/day dose groups were similar, with seizure reductions of 48.6% and 47.5% from baseline respectively, vs 26.5% for placebo (50 mg/kg/day vs placebo, p=0.0018). All key secondary endpoints were supportive of the effects on the primary endpoint. The safety profile observed is consistent with findings from previous studies, with no new safety risks identified.......?The positive outcome in this trial of EPIDIOLEX in patients with Tuberous Sclerosis Complex expands both our knowledge of this newly available medicine and its potential utility beyond the current indications,?...ENDE Zitat Quelle:https://www.otcmarkets.com/stock/GWPH/news/story?e&id=1349254
Hat jemand in diesem Thread Musse oder vielleicht im Tagesgeschäft genug Langeweile um mir zu erklären was das Chart zu bedeuten hat? Ich bin Anfängerin und charts sind für mich noch sehr schwer zu verstehen. obwohl ich nichts verstehe bin ich investiert. Lieben Dank im Voraus