GW Pharmaceutical Archives - Green Market Report

Debra BorchardtDebra BorchardtApril 6, 2020
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3min37110

The U.S. Drug Enforcement Administration (DEA) confirmed that the GW Pharmaceuticals plc (Nasdaq: GWPH) cannabidiol drug Epidiolex is no longer subject to the Controlled Substances Act (CSA). The DEA’s letter means that all federal controlled-substance restrictions have been removed for Epidiolex. This change takes effect immediately.

The stock was rising over 3% to lately trade at $85.06 on the news. This further lifts the stock from its 52-week low of $67.98.

“This notification from DEA fully establishes that Epidiolex, the only CBD medicine approved by FDA, is no longer a controlled substance under the federal Controlled Substances Act,” said Justin Gover, GW’s Chief Executive Officer.  “We would like to thank DEA for confirming the non-controlled status of this medicine. Importantly, the descheduling of EPIDIOLEX has the potential to further ease patient access to this important therapy for patients living with Lennox-Gastaut Syndrome and Dravet syndrome, two of the most debilitating forms of epilepsy.”

In 2018, the FDA approved Epidiolex for the treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) or Dravet syndrome in patients two years of age or older. It is the first prescription pharmaceutical formulation of highly purified, plant-derived cannabidiol (CBD), and the first in a new category of anti-epileptic drugs. At the time, the approval was groundbreaking as the DEA has classified cannabis as a schedule 1 drug meaning there was medicinal purpose for the substance. By approving the drug as a medicine, it turned this argument upside down. Today’s news further refutes the claim that cannabis should remain a schedule 1 drug.

Following FDA approval, Epidiolex was initially placed in Schedule V of the CSA. Following receipt of this DEA notification, GW has filed a post-approval supplement with FDA to remove Schedule V designation from Epidiolex.

The company said in a statement that once this process is completed in each state, prescriptions for Epidiolex, like other non-controlled medicines, will be valid for one year and can be easily transferred between pharmacies. The descheduling of Epidiolex also enables physicians to prescribe this breakthrough medicine free of the requirements of state prescription drug monitoring programs.

The medicine is marketed in the United States by Greenwich Biosciences, the U.S. subsidiary of GW Pharmaceuticals plc. The company said it will now begin the process of implementing these changes at the state level and through the EPIDIOLEX distribution network.


Debra BorchardtDebra BorchardtFebruary 25, 2020
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3min6800

GW Pharmaceuticals plc (GWPH) announced financial results for the fourth quarter and full-year ended December 31, 2019, with total net product sales of Epidiolex of $104.5 million for the fourth quarter and $296.4 million for the full year. Total revenues were $109 million and the S&P Capital IQ estimate was for revenue of $80 million and so the company beat on that metric.

In addition to the strong sales, the company also trimmed its net losses to $24.9 million versus the net loss of $71.9 million for the quarter ending December 31, 2018. The company did report a loss of $0.07 per share which missed the S&P Capital IQ estimate for a loss of $0.03 per share.

The stock fell over six percent in post-market trading to roughly $109, which could be due to the miss on the loss per share. CEO Justin Glover did say on the company’s earnings conference call that first-quarter sales should be consistent with the fourth quarter, which could be interpreted as not growing. That could also be the reason for the selling. The company is sitting pretty with cash and cash equivalents at $536.9 million.

“2019 was an exceptional and transformative year for GW, led by the successful launch of Epidiolex in the US and approval in Europe. The positive impact this medicine has had on thousands of patients and their families provides a compelling foundation for continued growth in 2020,” said Justin Gover, GW’s Chief Executive Officer. “We also expect 2020 to be an important year for our growing and developing product pipeline beyond Epidiolex as we build on our world leadership in cannabinoid science. We are focused on advancing nabiximols in the US in several indications and clinical programs with other potential products whilst continuing to bring Epidiolex to more patients in the US and Europe.”

Pipeline

The company also outlined several items in the pipeline including Multiple Sclerosis spasticity -3 positive Phase 3 trials completed in Europe with the US pivotal clinical program expected to begin in Q2 2020 to augment existing data package. For schizophrenia (GWP42003) the company has had a positive Phase 2a trial published and Phase 2b trial expected to start in the H1 2020. CBDV in autism has a 30-patient open-label study underway and initial data expected in 2020. The investigator-led 100 patient placebo-controlled trial in autism is underway.

 


Debra BorchardtDebra BorchardtFebruary 3, 2020
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9min16060

GW Pharmaceuticals

GW Pharmaceuticals (NASDAQ:GWPH) has filed a supplemental marketing application in the U.S. seeking approval to use Epidiolex (cannabidiol) oral solution to treat seizures associated with tuberous sclerosis complex, a rare inherited disorder characterized by the growth on non-cancerous tumors in many parts of the body. It affects approximately 40-80 thousand individuals in the U.S. and nearly one million people worldwide.

“The submission of this sNDA for Epidiolex is an important step towards the prospect of offering a new treatment option for those patients with TSC who battle difficult-to-treat seizures,” said GW Pharmaceuticals CEO, Justin Gover. “Having already obtained approval for Epdiolex in the treatment of seizures associated with Lennox-Gastaut Syndrome and Dravet Syndrome, this submission is based on positive Phase 3 data showing that Epidiolex reduced TSC-associated seizures, which include both focal and generalized seizures types. We look forward to working with the FDA toward an expected approval later this year.”

The statement said that TSC is a condition that causes mostly benign tumors to grow in vital organs of the body including the brain, skin, heart, eyes, kidneys, and lungs and is a leading cause of genetic epilepsy. TSC is typically diagnosed in childhood. More than 60% of individuals with TSC do not achieve seizure control with standard treatments.

Study Data

The sNDA is supported by data from a Phase 3 safety and efficacy study, results of which were recently presented at the American Epilepsy Society 2019 annual meeting. The study met its primary endpoint with patients treated with Epidiolex 25 mg/kg/day experiencing a significantly greater reduction from baseline in TSC-associated seizures compared to placebo (49% vs 27%; p=0.0009). Results for the 50 mg/kg/day dose group were similar, with seizure reductions of 48% from baseline vs 26.5% for placebo (p=0.0018).

Zynerba

Zynerba Pharmaceuticals (NASDAQ:ZYNE)reported that it has successfully achieved patient screening target in its 14-week CONNECT-FX (Clinical study of Cannabidiol (CBD) in Children and Adolescents with Fragile X) trial assessing the efficacy and safety of Zygel CBD Gel in children and adolescents ages three to 17 with full mutation Fragile X syndrome.

“This is an important milestone for patients with Fragile X syndrome and their caregivers as we move toward completion of enrollment in this pivotal trial,” commented Armando Anido, Chief Executive Officer of Zynerba. “I would like to thank all of our clinical investigators and their staff for their assistance thus far. Through strict entry criteria and overall trial design, we expect to enhance the study’s ability to demonstrate a strong signal of activity and minimize response variability. Having now achieved our screening target, we remain confident that we will announce topline results late in the second quarter of this year.”

The company said in a statement that it expects to disclose topline results of this study late in the second quarter of 2020. If the results are positive, the Company expects to meet with the U.S. Food and Drug Administration to determine the acceptability of the data as a basis to submit its New Drug Application for Zygel in FXS in the second half of 2020, with potential approval by mid-year 2021.


Debra BorchardtDebra BorchardtNovember 5, 2019
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3min18220

Cannabis biotech company GW Pharmaceuticals plc (NASDAQ: GWPH) saw its share tumble in aftermarket trading despite delivering solid earnings. The company reported third-quarter net sales of $86 million and $188 million in net sales in the first three quarters of 2019. So far over 15,000 patients have received Epidiolex prescriptions since launch. The stock was falling over 11% to roughly $118 in post-market trading.

Revenue for the quarter ending September 30, 2019, was $91.0 million versus last year’s $2.4 million for the same time period. This easily beat the estimate of $85.91 million. The net loss was $13.8 million compared to a net loss of $79.9 million for the third quarter in 2018. The company also reported the loss as $0.04 cents per share which was much improved over last year’s loss of $2.76 per share and handily beat the estimate for a loss of $0.85 cents per share.

“In this first year of launch, we are pleased to report continued Epidiolex revenue growth in the US. 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,” stated Justin Gover, GW’s Chief Executive Officer. “We see significant opportunity for the short, medium and long term and believe that all the fundamentals are in place to make Epidiolex a very successful brand. We can expect to see additional momentum from Europe as well as the launch of the Tuberous Sclerosis indication during 2020. On top of this, GW is ideally placed to consolidate its leadership in cannabinoid science through advancing several mid and late-stage pipeline programs in the months ahead.”

Cash and cash equivalents were $554.7 million compared to $591.5 million in 2018.

More Epidiolex statistics included that over 3,000 physicians have generated dispensed prescriptions since launch and there has been strong payor coverage with approximately 93 percent of all Commercial, Medicaid and Medicare lives in the US having a coverage determination, of which 65 percent are PA to indication or less restrictive.

The European Commission gave approval for Epidiolex in September 2019 and commercialization underway in France and Germany.


StaffStaffFebruary 26, 2019
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6min9760

It’s time for your Daily Hit of cannabis financial news for February 26, 2019.

On The Site

GW Pharmaceutical

GW Pharmaceuticals plc (NASDAQ: GWPH) announced its financial results for the quarter ending December 31, 2018 reflecting the company’s first sales of its cannabis drug Epidiolex. The stock jumped almost 8% in after-hours trading as the biotech company beat analyst estimates. Net sales began on November 1 and between that day and the end of the year, the company logged sales of $4.7 million.

GW Pharmaceuticals changed its fiscal year to begin on January 1, 2019. The revenue for the quarter was $6.7 million versus $4.0 million for the same time period in 2017.  The average estimate for revenues from Yahoo Finance was $5.35 million.

Zynerba

Zynerba Pharmaceuticals, Inc. (ZYNE) stock popped over 8% in early trading to lately trade at $5.45 after the company announced that it had received a patent covering the company’s CBD gel.

The company said in a statement, “The U.S. Patent and Trademark Office has issued US Patent No. 10,213,390, titled “Treatment of Fragile X Syndrome with Cannabidiol” which includes claims directed to methods of treating Fragile X Syndrome by administering a therapeutically effective amount of synthetic or purified cannabidiol. This new patent, which expires in 2038, is part of an expanding intellectual property portfolio covering the Company’s cannabidiol (CBD) product candidate, ZYN002 Transdermal CBD gel.”

In Other News

Purpose Investments Inc. announced the performance of Purpose Marijuana Opportunities Fund (the “Fund”) following the one-year anniversary of its inception. The Fund (NEO: MJJ) returned 53.43% over the period from January 31, 2018 to January 31, 2019, easily outperforming the Solactive North American Marijuana Index during the same period.

“The performance of Purpose Marijuana Opportunities Fund shows exactly why we believe active management is the most optimized way to invest in the cannabis sector,” said Greg Taylor, Chief Investment Officer of Purpose Investments and Portfolio Manager for the Fund. “Passive investing in a new industry, such as marijuana, often means chasing or missing opportunities because the indexes are rebalancing much more slowly than the market itself is moving. On the other hand, active investing allows you to capitalize on all of the opportunities while properly managing risks through a variety of different strategies and tactics.”

Marijuana Company Of America Inc.  (OTCQB: MCOA) announced that the United States Patent and Trademark Office issued the Company a patent for the formulation of its flagship CBD product, hempSMART Brain. hempSMART Brain is a wellness product formulated with a proprietary composition of natural ingredients and cannabidiol (CBD) for the enhancement of brain function. The U.S. Patent Office issued patent number 10,201,553. To view the patent on hempSMART™ Brain visit the link here.

Liht Cannabis Corp. (CSE: LIHT) (OTCQX: LIHTF) provided an “in-progress” update on the company’s first harvest in Las Vegas, Nevada. Kurt Keating, Director of Operations, reports, that the team has harvested close to 1000 plants to date, producing over 335 lbs of wet weight.  They are on schedule to complete the last two rooms by March 6th. The crop strains are: Bubba Kush, Moonshine Ghost Train Haze, Amherst Sour Diesel, Skywalker and Lemon Skunk.

Green Growth Brands, Inc. (CSE: GGB) (OTCQB: GGBXF) appointed Randy Whitaker as Chief Operating Officer, a new position within GGB. Mr. Whitaker has over 27 years’ experience in real estate, finance, and store operations.  Mr. Whitaker joins GGB from Belk, Inc. a privately held department store with over 293 locations.

Organigram Holdings Inc. (TSX VENTURE: OGI) (OTCQX: OGRMF) signed a letter of intent with the Société québécoise du cannabis (SQDC). This agreement solidifies the company’s position as a true national player in Canada’s legal adult use recreational cannabis marketplace. Organigram now has distribution in place for all ten Canadian provinces.


Debra BorchardtDebra BorchardtFebruary 26, 2019
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3min13150

GW Pharmaceuticals plc (NASDAQ: GWPH) announced its financial results for the quarter ending December 31, 2018 reflecting the company’s first sales of its cannabis drug Epidiolex. The stock jumped almost 8% in after-hours trading as the biotech company beat analyst estimates.

Epidiolex Sales

Epidiolex is the first plant-derived cannabinoid pharmaceutical ever approved by FDA and first ever approved medicine in the U.S. for Dravet syndrome. Net sales began on November 1 and between that day and the end of the year, the company logged sales of $4.7 million. The company said there were approximately 4,500 new patient enrolment forms in the first two month selling period and over 500 physicians had generated dispensed prescriptions in the first two month selling period. Look ahead to 2019, prescriptions in January grew 150% sequentially over December.

Financial Results

GW Pharmaceuticals changed its fiscal year to begin on January 1, 2019. The revenue for the quarter was $6.7 million versus $4.0 million for the same time period in 2017.  The average estimate for revenues from Yahoo Finance was $5.35 million.  The net loss for the quarter jumped to $71.9 million versus last year’s$61.8 million for the same time period. The company also beat the analyst estimates for earnings by three cents with its loss of $0.20.

“We are pleased by the high level of physician and patient demand for Epidiolex, and by the number of payors that have already made favorable coverage determinations for the product. With US launch taking place part way through the quarter, the two month selling period at the end of 2018 was primarily aimed at setting the commercial wheels in motion for the 2019 launch year. As we move into the New Year, prescription growth trajectory has been highly encouraging and we believe that we are on track to deliver a successful market introduction of this important new treatment,” stated Justin Gover, GW’s Chief Executive Officer. “In addition to the US launch, we look forward to a positive regulatory decision in Europe in the next few months, results of a Phase 3 trial in Tuberous Sclerosis Complex, and a number of advances in the pipeline.”

 


Debra BorchardtDebra BorchardtNovember 26, 2018
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4min7540

Before Tilray (TLRY) and Canopy Growth (CGC) took over cannabis stock portfolios, GW Pharmaceuticals plc (Nasdaq: GWPH) was the darling of the group. However, the recent positive news from this cannabis biotech company’s epilepsy study serves to remind investors that great good comes from cannabis research.

On Monday, GW Pharma announced positive top-line results of the second randomized, double-blind, placebo-controlled Phase 3 clinical trial of Epidiolex in the treatment of seizures associated with Dravet syndrome, a rare and severe form of childhood-onset epilepsy. The biotech company reported that in this trial, Epidiolex, when added to the patient’s current treatment, achieved the primary endpoint of reduction in convulsive seizures for both dose levels (10 mg/kg per day and 20 mg/kg per day) with high statistical significance compared to placebo. The company said that both doses also demonstrated statistically significant improvements on all key secondary endpoints.

“The positive outcome in this second trial of Epidiolex in patients with Dravet syndrome further reinforces the effectiveness of this newly available medicine in this particularly difficult to treat, childhood-onset epilepsy,” stated Ian Miller, M.D., Director, Epilepsy and Neurophysiology Program at Nicklaus Children’s Hospital in Miami, FL and principal investigator of the trial. “The totality of data from the controlled clinical trials completed for Epidiolex have shown clinically meaningful seizure reductions and a consistent safety and tolerability profile.”

The drug was recently approved by the FDA and given a classification as a schedule five drug in September. Schedule five drugs are considered to have a low level of abuse and include substances like Robitussin cough syrup or Lomotil diarrhea medicine.

“The positive results from this trial follow the recent FDA approval, DEA rescheduling and U.S. launch of EPIDIOLEX for the treatment of seizures associated with Dravet syndrome and Lennox-Gastaut Syndrome in patients two years and older. These data show an effective dose range in Dravet syndrome that is consistent with our FDA approved label, and which allows for dosing flexibility to address individual patient needs,” stated Justin Gover, GW’s CEO.

Study Results

The average age of the patients in the study was nine years. The patients were having approximately 12 convulsive seizures a month and approximately 35 total seizures per month. On average, patients were taking three anti-epileptic drugs (AED), having previously tried and discontinued on average, four other AEDs.

The statement said that during the treatment period, patients taking Epidiolex 20 mg/kg/day demonstrated a 46% reduction in convulsive seizures while patients taking Epidiolex 10 mg/kg/day achieved a reduction of 49%, compared to a 27% reduction in patients taking a placebo.
Results from the key secondary efficacy endpoints also showed statistical significance of both dose groups of Epidiolex compared to placebo, although the patients taking the placebo also experienced a drop in seizures. In the Epidiolex 20 mg/kg/day group, 49% of patients achieved a 50% or greater reduction in convulsive seizures from baseline over the treatment period, compared to 44% of patients taking Epidiolex 10 mg/kg/day, and 26 percent of patients taking the placebo.
Stock Performance
The stock jumped over 2% in pre-market trading having experienced a 52-week high of $179 in September, shortly after the change in scheduling. The stock closed on Friday at $124, above its year low of $105.

Debra BorchardtDebra BorchardtSeptember 27, 2018
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5min12220

The Acting Administrator of the Drug Enforcement Administration has placed FDA-approved drugs that contain CBD derived from cannabis and no more than 0.1 percent tetrahydrocannabinols  (THC) in schedule V. GW Pharmaceutical’s (GWPH) Epidiolex had been a schedule I controlled substance, with this new directive Epidiolex (and any generic versions of the same formulation that might be approved by the FDA in the future) will be a schedule V controlled substance.

Schedule five drugs are considered to have a low level of abuse and include substances like Robitussin cough syrup or Lomotil diarrhea medicine.

The order made it clear that other cannabis products would remain in the schedule 1 category. The statement said, “As further indicated, any material, compound, mixture, or preparation other than Epidiolex that falls within the CSA definition of marijuana set forth in 21 U.S.C. 802(16), including any non-FDA-approved CBD extract that falls within such definition, remains a schedule I controlled substance under the CSA.” The document is scheduled to be published on September 28, 2018.

The order also said, “Now that Epiodiolex has been approved by the FDA, it has a currently accepted medical use in
treatment in the United States for purposes of the CSA. Accordingly, Epidiolex no longer meets the criteria for placement in schedule I of the CSA.”

The order went on to stress that CBD material, “which includes, among other things, a drug product containing CBD extracted from the cannabis plant, is a Schedule I drug under the Single Convention.”

Dr. George E. Anastassov, Chief Executive Officer of AXIM Biotechnologies remarked, “Today’s news is an important step for the pharmaceutical cannabinoid industry. It signifies an understanding on behalf of the regulatory agencies in the United States, such as the FDA and DEA, that cannabidiol (CBD) has therapeutic potential and a very low potential for abuse and misuse. However, this applies ONLY to Epidiolex, i.e. to the molecule contained within this particular formulation. Otherwise, CBD still remains as a Schedule I controlled substance and the current classification is non-applicable to the rest of the products available on the market.”

Thoma Kikis, Chief Communications Officer of Kannalife Sciences said, “The DEA’s rescheduling of Epidiolex from a Schedule I to a Schedule V controlled substance gives cannabidiol (CBD) more credibility and recognition as a treatment in the U.S. that does, in fact, have medical value. This is a watershed moment for the cannabinoid industry, and very encouraging for Kannalife Sciences and the work we have done to research and develop our own CBD-derived molecule (KLS-13019) for the treatment of diseases with unmet medical needs, such as Chemotherapy-Induced Neuropathic Pain (CINP), Hepatic Encephalopathy (HE), and Chronic Traumatic Encephalopathy (CTE). However, there is still more work to be done.”

GW Pharmaceutical stock jumped over 8% on the news to lately trade at $176.


William SumnerWilliam SumnerAugust 7, 2018
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3min10100

The London-based pharmaceutical company, GW Pharmaceuticals (GWPH), today announced the release of its financial results for the quarter ending on June 30, 2018.

During the last quarter, the company earned FDA approval for its cannabis-based drug Epidiolex in the treatment of seizures associated with LGS or Dravet syndrome. The company expects the FDA to reschedule Epidiolex within the next 90 days. Additionally, the company submitted Epidiolex for approval by the European Medicines Agency and a decision on the drug is expected to occur by the first quarter of 2017. The EMA has already granted Epidiolex Orphan Drug Status, so expectations are high.

With FDA approval, the company is currently gearing up for expanded facilities to meet expected long-term demand and commercial products are already being manufactured and shipped to the United States.

The company currently holds approximately $440 million in cash and cash equivalents, up from $312 million as of September 30, 2017. Revenue for the nine months ending on June 30, 2018, was $14.2 million, compared to $7.8 million during the same period in the previous year. Losses for the period rose from roughly $112 million to $180 million.

Earlier during the day, the company held a conference call to go over the financial results, and a recording of the call will be made available on GW’s website for the next 90 days. In a statement, Justin Gover, the Chief Executive Officer for GW Pharmaceuticals, hailed the FDA’s approval of Epidiolex as a major medical breakthrough.

“We anticipate rescheduling to be completed within 90 days of FDA approval and for the product launch to take place in the Fall,” said Gover. “In preparation for launch, we have now completed the hiring of our U.S. sales organization and are engaged with patient organizations, physicians and managed care organizations/payors. This approval has been a transformative event for GW, not only opening a new chapter as a commercial-stage company, but also validating and reinforcing our world leadership in cannabinoid science, and the potential of our product pipeline.”


StaffStaffAugust 7, 2018
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7min8090

It’s time for your Daily Hit of cannabis financial news for August 7, 2018.

On The Site:

Aurora Cannabis Inc.

Aurora Cannabis Inc. (ACBFF) today announced that it has entered into a letter of intent to acquire HotHouse Consulting Inc. Founded in 2004, HotHouse provides greenhouse consulting services and specializes in hybrid greenhouse growing techniques. Initially, the company focused primarily on agricultural clients, but in the ensuing years has shifted towards the cannabis industry. Under the agreement, the company has granted 1,940,000 options to buy shares of Aurora to officers of HotHouse, which will vest annually over the next three years and are exercisable at $7.39 per common share.

Navy Capital

New York-based cannabis-focused institutional fund Navy Capital Green International Ltd. invested $3 million of equity into  Nevada-based Oasis Cannabis. Oasis is an integrated cannabis producer and retailer in Nevada. It is also a subsidiary of CLS Holdings USA Inc., which operates as Cannabis Life Sciences.

Navy Capital said that it has an extreme interest in the CLS patented extraction and processing technology. According to the company statement, Navy Capital or select others may invest an additional two million with a 15% overallotment for a total of up to $5,750,000 by August 15, 2018.

In Other News

GW Pharmaceuticals plc

GW Pharmaceuticals plc (GWPH) reported its fiscal Q3 results for the quarter ending June 30, 2018, with revenue rising 34.6% to $3.5 million. The net loss fell 31.7% to a loss of $35.7 million. The company will be meeting with FDA in the back half of the year to clarify regulatory pathway for Sativex (nabiximols) in MS spasticity. GW Pharma will also begin to study CBDV in autism this quarter.

“The recent FDA approval of Epidiolex represents a major medical advance for patients with Lennox-Gastaut Syndrome and Dravet syndrome. We anticipate rescheduling to be completed within 90 days of FDA approval and for the product launch to take place in the Fall,” stated Justin Gover, GW’s Chief Executive Officer. “In preparation for launch, we have now completed the hiring of our U.S. sales organization and are engaged with patient organizations, physicians and managed care organizations/payors. This approval has been a transformative event for GW, not only opening a new chapter as a commercial-stage company, but also validating and reinforcing our world leadership in cannabinoid science, and the potential of our product pipeline.”

22nd Century Group, Inc.

22nd Century Group, Inc. (XXII), a plant biotechnology company that is focused on tobacco harm reduction, Very Low Nicotine tobacco, and hemp/cannabis research, announced its second quarter 2018 financial results. The company posted net sales revenue of more than $6.9 million and significantly increased spending – to more than $2.7 million this quarter – on the Company’s Modified Risk Tobacco Product (“MRTP”) application to the U.S. Food and Drug Administration (“FDA”) for “BRAND A” Very Low Nicotine cigarettes. As of June 30, 2018, the Company had more than $53 million in cash and short-term investments, which are sufficient reserves to meet regular operating expenses for a number of years.

The company had a net loss for the three months ended June 30, 2018, of $6,739,000, or ($0.05) per share, as compared to a net loss of $3,356,000, or ($0.04) per share, for the three months ended June 30, 2017. The increase in the net loss for the second quarter of 2018 of $3,383,000, or 100.8%, was due primarily to the net increase in the operating loss of $3,758,000.

Arena Pharmaceuticals, Inc. 

Arena Pharmaceuticals, Inc. (ARNA) reported a net loss of 65 cents per share or  $31.8 million for the second quarter of 2018 versus last year’s loss of 77 cents per share. It was wider than the Zacks Consensus Estimate of a loss of 62 cents. Revenues totaled $4.0 million, consisting of $3.1 million in collaboration revenue, and $0.9 million in royalty revenue. At June 30, 2018, Arena’s cash, cash equivalents, and investments balance were $592.4 million and approximately 49.3 million shares of Arena common stock were outstanding.

“We have made significant progress over the past three months across our clinical programs, including the initiation of our ADVANCE Phase 3 program for ralinepag in patients with PAH. We are excited for the opportunity to potentially advance the treatment paradigm for patients suffering from this critical illness,” said Amit D. Munshi, President and CEO of Arena. “Additionally, we are pleased to have submitted our meeting request to the FDA for etrasimod in UC, and look forward to the data readout from our Phase 2 study of olorinab for pain associated with Crohn’s disease in September.”

NUGL Inc.

NUGL Inc. (NUGL) announces its North American Marketing Strategy. NUGL’s platform delivers exclusive profiles and features for brands and listings in the cannabis space leading search app offers every type of cannabis company and professional service the ability to create individual profiles for marketing, connecting and expanding client bases in and out of the NUGL community. NUGL’s platform also gives brands and listings cutting-edge software that helps their business expand their client base and network.



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