Is GW Pharmaceuticals (GWPH) Momentum Back?
Post# of 82
Posted On: 01/09/2015 1:44:42 AM
After the closing bell on Thursday, SandRidge Energy, Inc. (SD) reported robust operational performance on its financial results.
For the third quarter 2014, SD posted adjusted EBITDA, pro forma for divestitures and net of Noncontrolling Interest, of $225 million, a 41% increase year over year, and adjusted net income of $43.0 million, or $0.07 per diluted share, versus adjusted net income of $31.7 million, or $0.06 per diluted share, in the same period the prior year.
SD anticipates announcing 2015 capital plans and full year guidance in February.
SD is an oil and natural gas company. It focuses its exploration and production activities in the Mid-Continent region of the United States.
More about SandRidge Energy, Inc. (SD) at www.sandridgeenergy.com
**
Shares of GW Pharmaceuticals plc (GWPH) surged 12.74% on Thursday's trading session
According to GWPH, the U.S. Patent and Trademark Office (USPTO) has issued a Notice of Allowance for U.S. Application Serial Number 13/380,305, a patent which protects the use of CBD in the treatment of partial seizures.
The subject patent specifically covers a method of treating partial seizure comprising administering CBD (cannabidiol) to a patient wherein the CBD is present in an amount which provides a daily dose of at least 400mg.
A Notice of Allowance is issued after the USPTO makes a determination that a patent can be granted from an application. The issued patent from this application will provide an exclusivity period until June 2030.
GWPH has rights to a portfolio of intellectual property covering CBD and CBDV in epilepsy. This portfolio includes fourteen patent families containing one or more pending and/or issued patents with claims related to the use of CBD and/or CBDV in the treatment of epilepsy as well as compositions, extraction techniques, CBD and CBDV (cannabidivarin) extracts and pure plant-derived CBD.
GWPH reported an update on its development program for Epidiolex(R) (pure cannabidiol, or CBD) in the field of severe, drug-resistant childhood epilepsy.
In late October 2014, GWPH commenced a placebo-controlled Phase 2/3 clinical trial in Dravet syndrome and recruitment completed rapidly into Part A (pharmacokinetic and dose-finding) of this two part study and that this element of the trial has already completed randomization of the required 30 patients.
Part B of this Phase 2/3 trial is the Phase 3 element of the trial which will compare the effect of Epidiolex with that of placebo. Part B will commence in the first quarter of 2015 once the Part A safety data has been reviewed.
In addition to this Phase 2/3 trial, GWPH expects to commence a second pivotal Phase 3 trial in Dravet syndrome in parallel with the start of Part B of the Phase 2/3 trial.
Based upon the progress to date, GWPH now expects top-line data from at least one of the pivotal trials in Dravet syndrome by the end of 2015.
GWPH expects to commence two pivotal Phase 3 trials in Lennox-Gastaut Syndrome (LGS) around the end of the first quarter 2015. Based on progress to date, GWPH is working towards top-line data from at least one of the pivotal trials in LGS around the end of 2015.
In parallel with GWPH's formal clinical trial program, the FDA has granted 20 expanded access INDs and 7 individual emergency INDs to independent investigators in the U.S. to treat a total of approximately 410 children and young adults suffering from intractable epilepsy with Epidiolex. To date, approximately 220 children and young adults are now receiving treatment with Epidiolex in the U.S. at 15 clinical sites.
During 2014, GWPH reported clinical effect data on 58 patients who had reached 12 weeks of treatment. GWPH expects additional clinical effect data to be reported at medical meetings during both first and second half 2015.
Patients being treated in the expanded access program suffer from a range of treatment-resistant epilepsies. Data generated to date suggest the potential for Epidiolex to treat epilepsy syndromes beyond Dravet and LGS and, as a result, GWPH expects to commence clinical development programs in further potential target indications during 2015.
GWPH also announced the top-line results from the first of three Phase 3 trials for the investigational product Sativex(R) in the treatment of pain in patients with advanced cancer who experience inadequate analgesia during optimized chronic opioid therapy.
In this first trial, Sativex (as adjunctive treatment to optimized chronic opioid therapy) did not meet the primary endpoint of demonstrating a statistically significant difference from placebo. Although it missed the primary endpoint in this trial, based upon the positive data seen in the Phase 2 program, GWPH remains confident in the ability for Sativex to relieve cancer pain in this patient population
GWPH's Sativex is approved for the treatment of spasticity due to multiple sclerosis in 27 countries outside the U.S. In the U.S., a request for Special Protocol Assessment has been submitted to the FDA for a proposed single Phase 3 study in this indication.
GWPH has two additional pivotal Phase 3 trials ongoing which, if positive, would still allow the company to submit a New Drug Application with the FDA. GWPH looks forward to results from these two further studies later this year
GWPH is a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform in a broad range of disease areas
More about GW Pharmaceuticals plc (GWPH) at www.gwpharm.com.
**
Crown Equity Holdings Inc. (CRWE) is currently developing its CRWE Network ( www.CRWE-PR.com ), a growing network of community targeted sites.
It has recently included Fontana ( www.fontana.crwe-pr.com ), a city in San Bernardino County, California to the CRWE Network.
Fontana is located in a region east of Los Angeles that is known as the "Inland Empire". It is home to the California Speedway. This is a popular Speedway that hosts numerous small races as well as two major NASCAR races each year.
The City of Fontana had an estimated population in 2013 (U.S. Census Bureau) of 203,003, and represents an important marketplace for the CRWE Network, which business model is based on selling advertising to businesses targeting both locally and nationally
The CRWE Network has reached the 1487th community website in the U.S., associated with 3456 ZIP Codes, and includes coverage in the states of California, Mississippi, Michigan, Florida, Nevada and New York, as well as across 10 provinces in Canada.
CRWE provides marketing solutions that boost customer awareness and merchant visibility on the Internet
More about Crown Equity Holdings Inc. (CRWE) at www.crownequityholdings.com
**
Disclaimer: This material is for informational purposes only and should not be construed as an offer or solicitation of an offer to buy or sell securities. Investors should always conduct their own due diligence with any potential investment, with independent research and other professional advice. Read Full Disclaimer at CRWE-PR Finance www.finance.crwe-pr.com/disclaimer
For the third quarter 2014, SD posted adjusted EBITDA, pro forma for divestitures and net of Noncontrolling Interest, of $225 million, a 41% increase year over year, and adjusted net income of $43.0 million, or $0.07 per diluted share, versus adjusted net income of $31.7 million, or $0.06 per diluted share, in the same period the prior year.
SD anticipates announcing 2015 capital plans and full year guidance in February.
SD is an oil and natural gas company. It focuses its exploration and production activities in the Mid-Continent region of the United States.
More about SandRidge Energy, Inc. (SD) at www.sandridgeenergy.com
**
Shares of GW Pharmaceuticals plc (GWPH) surged 12.74% on Thursday's trading session
According to GWPH, the U.S. Patent and Trademark Office (USPTO) has issued a Notice of Allowance for U.S. Application Serial Number 13/380,305, a patent which protects the use of CBD in the treatment of partial seizures.
The subject patent specifically covers a method of treating partial seizure comprising administering CBD (cannabidiol) to a patient wherein the CBD is present in an amount which provides a daily dose of at least 400mg.
A Notice of Allowance is issued after the USPTO makes a determination that a patent can be granted from an application. The issued patent from this application will provide an exclusivity period until June 2030.
GWPH has rights to a portfolio of intellectual property covering CBD and CBDV in epilepsy. This portfolio includes fourteen patent families containing one or more pending and/or issued patents with claims related to the use of CBD and/or CBDV in the treatment of epilepsy as well as compositions, extraction techniques, CBD and CBDV (cannabidivarin) extracts and pure plant-derived CBD.
GWPH reported an update on its development program for Epidiolex(R) (pure cannabidiol, or CBD) in the field of severe, drug-resistant childhood epilepsy.
In late October 2014, GWPH commenced a placebo-controlled Phase 2/3 clinical trial in Dravet syndrome and recruitment completed rapidly into Part A (pharmacokinetic and dose-finding) of this two part study and that this element of the trial has already completed randomization of the required 30 patients.
Part B of this Phase 2/3 trial is the Phase 3 element of the trial which will compare the effect of Epidiolex with that of placebo. Part B will commence in the first quarter of 2015 once the Part A safety data has been reviewed.
In addition to this Phase 2/3 trial, GWPH expects to commence a second pivotal Phase 3 trial in Dravet syndrome in parallel with the start of Part B of the Phase 2/3 trial.
Based upon the progress to date, GWPH now expects top-line data from at least one of the pivotal trials in Dravet syndrome by the end of 2015.
GWPH expects to commence two pivotal Phase 3 trials in Lennox-Gastaut Syndrome (LGS) around the end of the first quarter 2015. Based on progress to date, GWPH is working towards top-line data from at least one of the pivotal trials in LGS around the end of 2015.
In parallel with GWPH's formal clinical trial program, the FDA has granted 20 expanded access INDs and 7 individual emergency INDs to independent investigators in the U.S. to treat a total of approximately 410 children and young adults suffering from intractable epilepsy with Epidiolex. To date, approximately 220 children and young adults are now receiving treatment with Epidiolex in the U.S. at 15 clinical sites.
During 2014, GWPH reported clinical effect data on 58 patients who had reached 12 weeks of treatment. GWPH expects additional clinical effect data to be reported at medical meetings during both first and second half 2015.
Patients being treated in the expanded access program suffer from a range of treatment-resistant epilepsies. Data generated to date suggest the potential for Epidiolex to treat epilepsy syndromes beyond Dravet and LGS and, as a result, GWPH expects to commence clinical development programs in further potential target indications during 2015.
GWPH also announced the top-line results from the first of three Phase 3 trials for the investigational product Sativex(R) in the treatment of pain in patients with advanced cancer who experience inadequate analgesia during optimized chronic opioid therapy.
In this first trial, Sativex (as adjunctive treatment to optimized chronic opioid therapy) did not meet the primary endpoint of demonstrating a statistically significant difference from placebo. Although it missed the primary endpoint in this trial, based upon the positive data seen in the Phase 2 program, GWPH remains confident in the ability for Sativex to relieve cancer pain in this patient population
GWPH's Sativex is approved for the treatment of spasticity due to multiple sclerosis in 27 countries outside the U.S. In the U.S., a request for Special Protocol Assessment has been submitted to the FDA for a proposed single Phase 3 study in this indication.
GWPH has two additional pivotal Phase 3 trials ongoing which, if positive, would still allow the company to submit a New Drug Application with the FDA. GWPH looks forward to results from these two further studies later this year
GWPH is a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform in a broad range of disease areas
More about GW Pharmaceuticals plc (GWPH) at www.gwpharm.com.
**
Crown Equity Holdings Inc. (CRWE) is currently developing its CRWE Network ( www.CRWE-PR.com ), a growing network of community targeted sites.
It has recently included Fontana ( www.fontana.crwe-pr.com ), a city in San Bernardino County, California to the CRWE Network.
Fontana is located in a region east of Los Angeles that is known as the "Inland Empire". It is home to the California Speedway. This is a popular Speedway that hosts numerous small races as well as two major NASCAR races each year.
The City of Fontana had an estimated population in 2013 (U.S. Census Bureau) of 203,003, and represents an important marketplace for the CRWE Network, which business model is based on selling advertising to businesses targeting both locally and nationally
The CRWE Network has reached the 1487th community website in the U.S., associated with 3456 ZIP Codes, and includes coverage in the states of California, Mississippi, Michigan, Florida, Nevada and New York, as well as across 10 provinces in Canada.
CRWE provides marketing solutions that boost customer awareness and merchant visibility on the Internet
More about Crown Equity Holdings Inc. (CRWE) at www.crownequityholdings.com
**
Disclaimer: This material is for informational purposes only and should not be construed as an offer or solicitation of an offer to buy or sell securities. Investors should always conduct their own due diligence with any potential investment, with independent research and other professional advice. Read Full Disclaimer at CRWE-PR Finance www.finance.crwe-pr.com/disclaimer
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