Tags Posts tagged with "insy"

insy

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The biotech sector will be one of the greatest beneficiaries of the global cannabis movement and is comprised of some of the most mature and best capitalized companies.

The Nasdaq was the worst performing exchange yesterday and biotech cannabis-focused firms traded lower on average. Although we continue to be bullish on this sub-sector of the cannabis industry, it is also the one that would be most impacted by a correction in the market.

This sector is comprised of some of most attractive long-term companies. We think recent weakness has created opportunity and we want to highlight five cannabis stocks every investor should be watching.

Insys Therapeutics (INSY) traded in a very volatile range after reporting its fourth quarter and full year financial results yesterday. Insys opened down almost 5% and the shares traded as low as $10.01 before finding support. INSY bounced off these lows and the shares ended the day up 2.2%. INSY is at $10.75 and Technical420 plans to average down and add to its position if the shares trade below $10. The shares are trading well below its average Wall Street price target (more than 60% upside to average price target). One of the main reasons why we are favorable on Insys is because we view the company as an acquisition candidate due to its valuable intellectual property and relatively cheap valuation.
Corbus Pharmaceuticals (CRBP) gave up all its gains from Monday and the shares are trading at $8.05 after a 2.4% move lower on weak volume. We continue to monitor CRBP from the sidelines after exiting our position within hours of entering. We are on the sidelines due to the misleading reports, the increased volatility, and the potential for the market to dip lower in the near term.
Cara Therapeutics (CARA) was under pressure yesterday and the shares are trading below the pricing of its recently announced financing. Technical420 remains favorable on Cara Therapeutics and see significant upside to current levels. The shares are trading at $17.92 after a 2.5% move lower and we plan to add to our position on continued weakness. Cara plans to use the proceeds from its $80 million raise to fund clinical and R&D activities, including the completion of the Phase 3 program in uremic pruritus, two Phase 3 trials in acute pain and a Phase 2b trial in osteoarthritis pain. We will keep you updated on how the shares trade today.
GW Pharmaceutical (GWPH) edged lower on light volume yesterday and the shares are currently trading below its 20 and 50-day moving average. GWPH has fallen 8% in the last month and we view the shares as an attractive long-term opportunity at current levels. GW has one of the deepest pipelines of products in advanced stages of FDA testing. The company also has the best Wall Street coverage and has received buy ratings from Goldman Sachs, Merrill Lynch, and Morgan Stanley. We view GW as an acquisition candidate and Goldman Sachs estimated a $390 a share acquisition price if that was to occur. From the filing of a New Drug Application to multiple Phase 3 Clinical trials, GW Pharma is an event-driven story that has many potential catalysts. We plan to hold and add to our position on continued weakness.
Zynerba Pharmaceuticals (ZYNE) continues to be one of the most attractive cannabis biotech investment opportunities due to the relatively cheap valuation, its high-quality pipeline of products, the number of upcoming catalysts, and its favorable and improving Wall Street coverage. In late March, H.C. Wainwright raised Zynerba’s price target to $30 from $22. The average price target on shares of Zynerba is north of $30 and offers more than 50% upside to current levels.

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From the National Cancer Institute (NCI) to the National Institute on Drug Abuse (NIDA), U.S. government agencies continue to change its stance pertaining to medical cannabis.

Last year, the NCI updated its website to include various studies that reveal how cannabis may inhibit tumor growth by killing cells. The NIDA revised their April 2015 publication to say that marijuana can kill certain cancer cells and reduce the size of others.

Countries across the globe continue to legalize cannabis and it is only a matter of time until the U.S. gets on the bandwagon. Although the market continues to keep its eyes on the U.S. cannabis industry, its neighbors to the north continue to be the global cannabis leader.

Biotech Bets

The biotech sector will be one of the greatest beneficiaries of legal cannabis and companies focused on this opportunity have outperformed the market over the last quarter.

We highlighted Vinergy Resources (VIN.CN) as a stock to watch after its acquisition of MJ Biopharma in mid-December and the market responded very favorably to this all-stock purchase.  At the time of this announcement, Vinergy also announced a non-brokered private placement offering of up to 10,000,000 units at $0.20 per unit.

MJ Biopharma is a private cannabis technology company based out of British Columbia that is currently focused on manufacturing breath strips, time release capsules, extract oils, food products such as infused juices, teas, coffee and extract drinks, as well as the development of pharmaceutical grade delivery systems. The company is also focused on licensing and partnering on the development of technologies and products for the medical and recreational cannabis market in Canada and abroad.

Vinergy’s market sentiment has improved significantly following the acquisition and investors were able to acquire stock at a more than 50% discount to the current price through the private placement. The offering generated incredible interest and is very oversubscribed. Investors should keep an eye on Vinergy as we expect to see the company build off of this momentum.

An Agreement Based on Success

One of the reasons why we were favorable on the aquisiton of MJ BioPharma was due to the milestone-based compensation strucutre. Vinergy issued 5 million shares to MJ BioPharma shareholders and can issue up 3.75 million more shares based on the completion of certain milestones.

  • The company will issue an additional 2.75 million shares upon the commercialization of MJ BioPharma’s strip technology.
  • One million shares will be issued when each of two alternative selected extractions/products are ready for commercialization.

Banking on Biotech

Although we continue to expect the biotech sector to benefit the legal cannabis movement, we are watching how these companies are impacted by a new White House administration.

The biotech sub-sector of the cannabis industry is comprised of some of the most mature cannabis businesses. We continue to view these companies as some of the most attractive cannabis investments and want to discuss our view of these companies at their current levels.

GW Pharmaceuticals (GWPH) has rallied off its recent lows and we remain bullish on the company due to its deep pipeline of pharmaceutical products that are in advanced stages of FDA testing. The company has a number of catalysts in the back half of 2017 and we see significant upside to current levels.

Zynerba Pharmaceuticals (ZYNE) continues to remain one of our top picks in the cannabis sector as we see significant upside to current levels. The average Wall Street price target on ZYNE is north of $30 and we view the company as an acquisition candidate for any biotech company interested in the cannabis industry.

Insys Therapeutics (INSY) has also rallied off its recent lows and the shares fell more than 60% during 2016. We believe that all of the legal concerns are priced into INSY and see significant upside to current levels. Like Zynerba, we view Insys as an acquisition candidate and view the company as a long-term investment opportunity.

 

Join Technical420 and Capitalize on the Rapidly Growing Cannabis Industry…

 

Important Investor Disclosures 

Disclosure.  Compensated Affiliate.  This report was authored by and is property of StoneBridge Partners LLC.  All information and data relied upon in drafting this report is publicly available.  The author believes and considers its sources to be reliable, but does not guarantee the accuracy or completeness of any information contained in this report.  Any and all information, data, analyses and opinions are provided for informational purposes only and is not intended, in any manner, as investment advice.  Any projections or other information generated by StoneBridge Partners LLC regarding the likelihood of various investment outcomes are hypothetical in nature, do not reflect actual investment results, and are not guarantees of future results.  None of the material contained in this report is intended as a solution or offer to sell or purchase a specific stock or any other investment.  This report is not directed to, or intended for distribution or use by, any person or entity that is a citizen, resident or located in any municipality, state, country or other jurisdiction where the distribution, publication, availability, or use of this report is contrary to any governing law or regulation.  The securities discussed in this report may not be eligible for purchase and/or sale in certain jurisdictions or by particular individuals.  It is important that you check any and all governing laws and/or regulations that may be applicable in your jurisdiction.  Investing in securities of issuers organized outside of the United States, including ADRs, entail certain risks.  The securities of non-United States issuers may not be registered with, nor be subject to the reporting requirements of the United States Securities and Exchange Commission.  Please contact a Financial Advisor for professional advice regarding any and all securities investments.  This report is intended for informational purposes only.  StoneBridge Partners LLC’s officers, directors, employees, affiliates, or subsidiaries may have positions in securities covered by StoneBridge Partners LLC.  StoneBridge Partners LLC receives compensation from the company and/or has a position in the securities mentioned in this report

 

Authored by: Micheal Berger

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Insys Therapeutics, Inc. to Present at Piper Jaffray 28th Annual Healthcare Conference

Insys Therapeutics, Inc. (“Insys” or “the Company”) (INSY) today announced that Darryl Baker, Chief Financial Officer, and Santosh Vetticaden, MD, PhD, Senior Vice President and Chief Medical Officer, will present at the Piper Jaffray 28th Annual Healthcare Conference as follows:
Date: Wednesday, November 30, 2016
Time: 9:30 a.m. Eastern Standard Time
Location: Lotte New York Palace, New York

The presentations will be webcast live at the aforementioned times as well as archived for 90 days thereafter, via the Company’s website at www.insysrx.com, under the Investors Section.

About Insys Therapeutics, Inc.

Insys Therapeutics is a specialty pharmaceutical company that develops and commercializes innovative drugs and novel drug delivery systems of therapeutic molecules that improve the quality of life of patients. Using proprietary sublingual spray technology and capabilities to develop pharmaceutical cannabinoids, Insys is developing a pipeline of products intending to address unmet medical needs and the clinical shortcomings of existing commercial products. Insys currently markets one product, SUBSYS® (fentanyl sublingual spray) but has received approval for the marketing of SYNDROSTM (dronabinol oral solution), a proprietary, orally administered liquid formulation of dronabinol that Insys believes has distinct advantages over the current formulation of dronabinol in soft gel capsule.  Insys is committed to developing medications for potentially treating addiction to opioids, opioid overdose, epilepsy, and other disease areas with high unmet need.

SUBSYS® and SYNDROSTM are trademarks of Insys Development Company, Inc., a subsidiary of Insys Therapeutics, Inc.

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WASHINGTON — The administration of “Yes We Can” is now the administration of “No We Won’t,” in a ruling that keep marijuana as a schedule 1 drug. No one at Marijuana Stocks is surprised by this ruling from the administration via the lengthy statement from the Drug Enforcement Administration (DEA). Again the Cannabis advocates, activists & patients in need of the properties associated with Medical Marijuana were given some crumbs in true “Hunger Games” Style. As of today’s ruling by the DEA the study of cannabis will be expanded in order to ascertain the potential medical benefits of cannabinoids. Marijuana will continue to be on the list of the most dangerous drugs, regardless of growing support for legalization and more states changing their laws to have some form of medical marijuana or recreational marijuana on the books.

“By punting the reclassification of marijuana debate the DEA exposes themselves to the utter hypocrisy of our classification system. Consider Cocaine and OxyContin are class 2 drugs and are far more ruinous to the people that use and abuse them, yet cannabis which can’t kill you is a class 1 drug which by definition means there are no medical benefits and highly addictive.” Said an agency source under the condition of anonymity.
The Health and Human Services Department was so bold today as to double down on the illogical argument on marijuana by saying cannabis “has a high potential for abuse” and “no accepted medical use.”
A statement of that nature exposes some problems with that argument as well as showing who is potentially to blame for the bureaucracy surrounding these kind of government rulings. Let’s examine this statement and try and draw some conclusions on our own.

First, if marijuana has no medical properties or potential benefits why are BigPharma companies spending hundreds of millions of dollars in research and development to study marijuana and create drugs for patients? Abbvie Inc (ABBV) has had a cannabis related drug it has marketed since 1985 for example called Marinol (Dronabinol Extract) which is an appetite stimulant used by cancer patients. INSYS Therapeutics Inc (INSY) was just given FDA approval for its orally administered drug called Syndros last month which is similar to ABBV’s appetite drug. GW Pharmaceuticals (GWPH) has a drug called Epidiolex for people suffering from seizures, they are also creating their own strains of cannabis for individual targeted Cannabinoids. Any person that has ever used medical marijuana for example knows that one of its side effects is hunger or the “munchies.” Why try and synthesize a drug when nature and thousands of years of use has produced the same result you ask? Money from prescription drugs, money from speculation on the public company creating these drugs and ridiculous ways to capitalize from the insurance that pays for it all. The reality is that cannabis is essentially a weed that grows all over the world and the pharmaceutical industry would lose potentially hundreds of billions of dollars if cannabis was federally legal. Which leads me to point two in exposing the bureaucracy tied to Big Pharma.

So how do the lawmakers in the United States and agencies like the DEA come to these irrational conclusions that lack all common sense? Lobbyists on K Street in DC for starters. Given medical marijuana’s position as a cheaper, safer alternative to pharmaceutical products, pharmaceutical companies stand to lose a significant chunk of market share if marijuana legalization were to pass. BigPhRMA is universally recognized as marijuana’s biggest financial competitor, with drug manufacturers giving a whopping $21.8 million to a myriad of federal candidates and committees, as well as political parties during election times. In 2013 alone, Big Pharma spent approximately $18 million solely on lobbying, according to OpenSecrets. While easily one of the biggest contenders to the marijuana industry, Big Pharma was hit with a crucial turning point, a survey of 473 adult therapeutic cannabis users, conducted by the Centre for Addictions Research of BC, found that 87% of respondents gave up prescription medications, alcohol, or other drugs in favor of cannabis.

Other Lobbies that are fighting relentlessly against cannabis are private prison corporations as well as the alcohol & tobacco industry. For mor info on that here’s an article on the top five lobby’s.

In the end officials need to get elected and no one wants to piss off their donors, grassroots organizations like Norml or the Marijuana Policy Project are fighting a war against opponents that have unlimited resources. Even so the expansion of study does crack the door open for the industry and in our opinion prohibition will eventually end. Once the government and big business set up the infrastructure to capitalize on cannabis they will demand their piece of the pie, which has an estimated black market value of $50,000,000,000 and a legal US market estimated at $6,000,000,000. That might be a scary thought, but there will always be artisanal cannabis for the masses and the best growers in the industry don’t need to become sellouts which is positive to us.
Here is the statement from the DEA today. Share this article, Tweet it, Facebook it, email it to your friends and congressman. Everyone must do their part or the elected officials we put in office will continue to vote against our collective interests.

Regards,

@WolfofWeedSt

DEA

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    MarijuanaStocks.com asked FBEC Worldwide Inc’s (FBEC) chief scientist Linda Strauss an adjunct professor at UC San Diego and Co-Founder of G Randel & Sons a development company that specializes in CBD based R&D for product creation her thoughts on INSY from a drug standpoint. “Looking at the market’s reaction to Insy Therapeutics’ (INSY) announcement two weeks ago that the U.S. Food and Drug Administration (FDA) has approved its dronabinol oral solution, SyndrosTM, you would think this was a breakthrough treatment. However, it is not, but that doesn’t make it any less important an announcement. SyndrosTM is an orally administered liquid formulation of the pharmaceutical cannabinoid dronabinol, which is a pharmaceutical version of tetrahydrocannabinol (“THC”), one of the main active ingredients in cannabis. Dronabinol has been on the market since 1985, marketed by AbbVie ($ABBV) as Marinol. Marinol was developed and approved for the treatment of nausea and vomiting associated with cancer chemotherapy inpatients that had failed to respond adequately to conventional antiemetic treatments. SyndrosTM is only the second pharmaceutical cannabinoid to win approval by the FDA for marketing in the United States. Unlike Marinol, which is manufactured as a capsule containing THC in sesame oil, SyndrosTM is an orally administered liquid formulation that has a quicker onset and can be self­titrated, meaning the patient can use as much or as little as they need by making small adjustments in the amount they take.

    SyndrosTM carries the same risk of side effects as Marinol including psychiatric and cognitive effects and impaired mental and/or physical abilities. There are only a limited number of patients who would stand to benefit from a product like SyndrosTM. Patients currently taking Marinol are the most likely to benefit by switching to SyndrosTM as they would be able to self­titrate their own dosage and improved bioavailability. Ultimately this is a good sign that the FDA is willing to approve new cannabinoid drugs that meet their high standards for approval including those derived from the cannabis plant itself rather than it being derived synthetically.”

    All of this bodes well for the big board pharma companies looking to synthesize specific parts of the cannabis plants for drug treatments as a ruling from the Drug Enforcement Administration is expected to happen within the next 6 month. The referenced ruling is in regards to the possible rescheduling of Cannabis. Marijuana is currently listed as a schedule 1 drug alongside LSD, Crystal Meth, Heroin, MDMA (ecstasy) and Mescaline (peyote), despite the fact that cannabis has never caused a person to die from overdose. Advocates have long felt that the demonization of marijuana and lack of study has been more about politics than common sense measures. If cannabis is rescheduled to class 2, 3 or removed entirely the entire industry will expand rapidly. The first companies to benefit will be, ironically, in the sector that has lobbied against cannabis so ardently; Big Pharma. These Biotech companies want a schedule 2 classification which would expand the study, while everyone would settle for 3 or complete removal.

    Michael Berger from Technical420.com stated “The rescheduling of cannabis will serve as a major catalyst for the biotech industry and those companies that have cannabis related drugs in their drug trial pipeline will bring in new investors that were once gun shy about Marijuana Stocks due to the current classification.” He went on to tell MarijuanaStocks.com that “current speculation from industry insiders is that companies like INSY, CARA, ZYNE GWPH could all be acquisition targets from some of the Big Pharma super powers.”

    There’s no doubt in our mind that this would be an event driven catalyst that the Marijuana sector thrives on, enhancing the overall public & private markets. We can only hope that common sense and logic will win out there by opening the door to full legalization.

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    This morning Insys Therapeutics (INSY) made a MAJOR announcement this morning and more importantly could be a catalyst for a huge short squeeze.  Pull up any info on short interest regarding this stock and it won’t take long to understand the sheer magnitude that this news could have as far as the potential for a squeeze.  This has been a company that we’ve followed for quite some time.  The Wolf Of Weed Street and Marijuana Stocks social media outlets have been very vocal and now today we can confirm that INSY has officially announced the approval by the FDA for the company’s dronabinol oral solution, SyndrosTM.  See the full release below:

    Insys Therapeutics Announces FDA Approval of Syndros™

    PHOENIX, July 05, 2016 (GLOBE NEWSWIRE) — Insys Therapeutics, Inc. (“Insys” or “the Company”) (INSY) today announced that the U.S. Food and Drug Administration (FDA) has approved Insys’ dronabinol oral solution, SyndrosTM, an orally administered liquid formulation of the pharmaceutical cannabinoid dronabinol, a pharmaceutical version of tetrahydrocannabinol (“THC”). Syndros is approved for use in treating anorexia associated with weight loss in patients with AIDS, and nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments. Syndros is currently awaiting scheduling by the U.S. Drug Enforcement Administration.

    “We are very pleased to announce FDA approval of Syndros. We believe that Syndros will be an important new treatment option for patients suffering from the devastating effects of chemotherapy induced nausea and vomiting, as well as those fighting anorexia associated with weight loss in AIDS,” said the Company’s Chairman, CEO and President, Dr. John N. Kapoor.

    “Syndros is the first and only FDA approved dronabinol solution for oral use. It is a liquid that is easy-to-swallow and allows for the dosage to be titrated to clinical effect. Once Syndros has been opened, it does not need to be refrigerated for 28 days. We believe that these product features coupled with patient support services will prove to be important differentiators for patients and prescribers and will be key drivers of a successful market launch and sustained growth. We expect that Syndros’ attractive profile will enable rapid market conversion and expansion, making for a significant long-term commercial opportunity for Insys,” added Dr. Kapoor.

    Approximately 9,500 prescribers account for 70% of current dronabinol prescriptions. Insys expects to convert a large portion of the market to Syndros as well as expand the market through direct detailing to physicians, highlighting the improved product profile of Syndros. The Company anticipates launching Syndros in the second half of 2016.

    Indications

    AIDS

    SyndrosTM is approved for anorexia associated with weight loss in patients with AIDS.

    Oncology

    SyndrosTM is approved for nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments.

    Important Safety Information

    Syndros may cause psychiatric and cognitive effects and impair mental and/or physical abilities. Patients with cardiac disorders may experience hypotension, hypertension, syncope, or tachycardia. Discontinue products containing disulfiram or metronidazole at least 14 days before and do not administer 7 days after treatment with Syndros (see Full Prescribing Information).

    Weigh the potential risk versus benefits before prescribing SyndrosTM to patients with a history of seizures, including those requiring anti-epileptic medication or with other factors that lower the seizure threshold. Assess risk for abuse or misuse inpatients with a history of substance abuse or dependence, prior to prescribing SyndrosTM and monitor for the development of associated behaviors or conditions. Consider dose reduction or discontinuation, if worsening of symptoms of paradoxical nausea, vomiting, or abdominal pain worsen while on treatment.

    To learn more about SyndrosTM, and its Important Safety Information, please contact INSYS Therapeutics, Inc. at 1-855-978-2797.

    About Insys Therapeutics, Inc.

    Insys Therapeutics is a specialty pharmaceutical company that develops and commercializes innovative drugs and novel drug delivery systems of therapeutic molecules that improve the quality of life of patients. Using proprietary sublingual spray technology and capabilities to develop pharmaceutical cannabinoids, Insys addresses the clinical shortcomings of existing commercial products. Insys currently markets one product, Subsys® (fentanyl sublingual spray) but has received approval for the marketing of SyndrosTM (dronabinol oral solution), a proprietary, orally administered liquid formulation of dronabinol that Insys believes has distinct advantages over the current formulation of dronabinol in soft gel capsule. Insys is developing a pipeline of sublingual sprays, as well as pharmaceutical cannabidiol. Insys is committed to developing medications for potentially treating addiction to opioids, opioid overdose, epilepsy and other disease areas with high unmet need.

    Subsys® and SyndrosTM are trademarks of Insys Therapeutics, Inc.

    Forward-Looking Statements

    This press release contains forward-looking statements regarding: (i) our belief that Syndros will be an important new treatment option for certain patients, (ii) our belief that certain benefits of Syndros will be important differentiators for patients and prescribers, (iii) our belief that these benefits will be key drivers of a successful market launch and sustained growth and our expectations that that Syndros’ attractive and differentiated profile will enable rapid market conversion as well as increase Syndros usage; and (iv) our anticipated timing of the commercial launch of Syndros. These forward-looking statements are based on management’s expectations and assumptions as of the date of this press release; actual results may differ materially from those in these forward-looking statements as a result of various factors, many of which are beyond our control. These factors include, but are not limited to risk factors described in our filings with the United States Securities and Exchange Commission, including those factors discussed under the caption “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2015 and subsequent updates that may occur in our Quarterly Reports on Form 10-Q. Forward-looking statements speak only as of the date of this press release and we undertake no obligation to publicly update or revise these statements, except as may be required by law.

    Contact:

    Investor Contact:
    Lisa M. Wilson
    President
    In-Site Communications, Inc.
    212-452-2793

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    Monday (3/14), one of the cannabis industry leaders, GW Pharma (GWPH) announced positive results from its first Phase 3 study of Epidiolex in the treatment of Dravet syndrome. Epidiolex already has orphan drug designation and Fast Track Designation from the FDA for this rare form of epilepsy. Currently there are no treatments approved in the U.S. The Active substance in Epidiolex, cannabidiol or CBD, has been the source of conversation and controversy for years.

    Many doctors have even condemned it as a false therapy for things like cancer and, yes, epilepsy. But with the advent of strains like Charlotte’s Web, which have shown to drastically curb the affects of epilepsy, these Phase 3 results may confirm much of what many in the health community has already confirmed, which is that CBD’s can be a strong reactive therapy for debilitating diseases like this.

    These findings could mean big things for the marijuana industry, as the ripple effect seems to have already begun. GW Pharma stock sprinted 120% to 84.71 in the stock market Monday, hitting a three-month high above 91, intra-day. The news also jump started other cannabis-related stocks like Insys Therapeutics (INSY), which rose 11% to 18.89, and the recently IPO’d Zynerba Pharmaceuticals (ZYNE), which increased to a six month high of $21.08; up 150%.

    Like GW Pharma, Insys is also testing a CBD product in Dravet syndrome, and similarly has been granted an orphan-drug designation from the FDA. Zynerba is developing a form of CBD that can be applied through the skin. In a recent PR, ZYNE reported that in the first half of 2016, the Company expects to report final results from its ongoing Phase 1 single rising dose clinical trial, including results from 12 patients with epilepsy.

    Other CBD Related Stocks Seeing More Attention From GW’s Findings:

    FBEC Worldwide, Inc. (FBEC)

    Originally focused on providing hemp based energy drinks, FBEC has also spread its reach into the quality CBD marketplace through its distribution of Ma Brand CBD. Late last year the company signed a Joint Venture agreement with CBD Globe Distributors Ltd. in which FBEC will own 50.1% of the newly formed Joint Venture LLC and receive 50% of the net profit from its operations. According to CBD Globe, it has invested over $200,000 in production and development of the Ma brand itself and already has 10,000 units packaged and ready for sale. The CBD vaping product has a highly refined CBD oil made from hemp, grown in the United States.

    Top UFC contender, Anthony “Rumble” Johnson, has endorsed the company’s hemp energy shot product. Furthermore, its most recent announcements have dealt heavily with revamping its share structure and curbing potential sources of future dilution. FBEC shares rose just over 25% from Monday’s open and closed at the high of day.

    GreenGro Technologies, Inc. (GRNH)

    GRNH also acquired Greensticks, Inc.; a patent pending technology for an electronic vaporizer for Cannbidiol (CBD). Branded as a new way to medicate, Greensticks is a battery powered electronic vaporizer designed to look like an electronic cigarette. The cartridges are filled with 100% organic liquefied flowers and pharmaceutical grade glycol as found in asthma inhalers.

    GRNH recently announced record-breaking 242.94% year-over-year sales growth through the first quarter of 2016. According to the company, this timely growth came as a result of new customers along with renewals and the ongoing expansion of the company’s product lines. Additionally, sales increased by 209.57% from the fourth quarter of 2015 to the first quarter of 2016. Along with many other marijuana stocks, GRNH shares increased by nearly 60% from open to high and closed the Monday session at its HOD of $0.349 on more than 5 times it’s average 30-day volume.

    Medical Marijuana Inc. (MJNA)

    This marijuana stock saw very heavy volume on Monday with price increasing by a modest 7% from its previous close, Friday. The company announced at the beginning of March that its portfolio investment company, KannaLife Sciences, Inc. has received the necessary 2016 quota allotment from the U.S. DEA to import high-purity, pharmaceutical-grade cannabidiol into the U.S.

    KannaLife is currently focused on the feasibility studies with Catalent Pharma to develop a cannabinoid-derived therapeutic agent for the treatment of two neurodegenerative diseases: Hepatic Encephalopathy and Chronic Traumatic Encephalopathy; forms of brain degradation in humans that can be due to things like head trauma.

    Cannabis Science, Inc. (CBIS)

    This stock saw an incredible day on Monday as well. The stock increased from an opening price of $0.01 to a high of $0.0194. The stock ended the day, closing up just under 50%. The company is continuing testing and providing limited rollouts for its own CBD-based treatment products in California. The company has taken a strong stance to increase shareholder value.

    In recent press Cannabis Science’s CEO announced that he will be gifting his own shares to shareholders in lieu of previously announced dividends. That date of record for shareholders has been extended to March 31, 2016.

    CV Sciences. (CANV)

    The stock saw nearly 3 times its average 30-day volume on Monday fueled by excitement in the marijuana sector. Share prices rallied up more than 75%. In most of the recent press releases, the company has been focused on extinguishing the remainder of its convertible debt and as of early March, CANV management confirmed that 100% of the outstanding convertible promissory notes have been retired.

    Following the acquisition of CanX and Canabine earlier this year, the company has taken a firm stance on efforts to develop synthetically-formulated CBD for use in drug development activities. In particular, they are looking to pursue approval of the FDA for drugs with specific indications utilizing cannabidiol as the active pharmaceutical ingredient. Board Chairman James A. McNulty has been an active contributor to biotechnology and health care related companies, including BioDelivery Sciences International, Inc. (BDSI), Hedgepath Pharmaceuticals, Inc. (HPPI), Accentia Biopharmaceuticals, Inc., and Biovest International, Inc. He is also a former shareholder of CanX, which brings this full circle.

    Conclusion

    There are obviously many more marijuana stocks that could be mentioned here but it would seem that the CBD-centric companies like those mentioned, have begun to benefit from the latest ground breaking announcement that GW Pharma has just made with regard to a successful Phase 3 study. With such a late stage success, we think that the hemp, CBD and cannabis space will be a topic of major discussion in 2016.

     

     

    Additional disclosure/disclaimer

    An affiliate of MAPH Enterprises, LLC MarijuanaStocks.com | WolfofWeedStreet.com was paid an advertising fee of $60,000 cash & 60 Million Restricted Common shares by FBEC Worldwide Inc. (FBEC) for visual sponsorship of MarijuanaStocks.com | WolfofWeedStreet.com and for visual placement FBEC Worldwide Inc. (FBEC) within written materials. FOR A DURATION OF 5 YEARS BEGINNING JUNE 2015 ending JUNE 2020

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    Insys Therapeutics Responds to False and Misleading Report

    PHOENIX, Dec. 04, 2015 (GLOBE NEWSWIRE) — Insys Therapeutics, Inc. (INSY) (“Insys” or “the Company”) today issued the following response to a recent report containing accusations centered on adverse events1 and diversion related to the Company’s breakthrough cancer pain drug, Subsys®.

    Patient Safety Is Insys’s Primary Concern: Insys takes patient safety very seriously and is committed to working with the health care community, including health care providers (“HCP”), payors, pharmacies, and most importantly, patients, to help ensure the proper prescribing and use of the Company’s products. As a manufacturer of a breakthrough cancer pain drug, Insys is also committed to complying with corresponding laws and regulations, including those related to adverse event reporting. In keeping with the U.S. Food and Drug Administration’s (“FDA”) regulations, Insys strives to report serious, unexpected adverse events to the FDA within fifteen days of learning of the event. In accordance with this commitment, Insys has submitted to the FDA a quarterly report of adverse events related to Subsys since Insys launched this product in March of 2012. In addition, Insys sales representatives are trained to understand and comply with the reporting requirements related to adverse events as outlined by the Federal Food, Drug & Cosmetic Act.
    Given the Approved Indication of Subsys, It Is Not Unexpected that a Percentage of Patients Pass Away While on Subsys: Subsys is indicated for the management of breakthrough pain in cancer patients 18 years of age and older who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. Patients must remain on around-the-clock opioids when taking Subsys. In light of the approved indication of Subsys, it is not unexpected that a percentage of patients, many of whom are gravely ill with cancer, pass away while on Subsys; this does not establish that these patients’ deaths were caused by their use of Subsys.
    The FDA’s Adverse Events Reporting System Presents Clear Data Around Adverse Events Concerning Subsys: Adverse events included in the FDA Adverse Event Reporting System include events that occur while a patient is using a pharmaceutical product regardless of whether they are related to, let alone caused by, the pharmaceutical product in question. Since the launch of Subsys, the FDA’s Adverse Events Reporting System lists 244 deaths. Of these 244 cases, three were definitively due to Subsys overdoses (one accidental, one intentional and one unknown).

    Additional data shows that of these 244 cases, 134 cases were reported by the HCP as due to the cancer for which they were prescribed Subsys. Eight of the 244 cases were reported by the HCP as not due to cancer but definitely were not due to Subsys. 83 of the 244 cases as reported were due to unknown causes as Insys was unable to obtain the information from the HCP after multiple requests. In six of the 244 cases, the HCP was uncertain whether or not the patient was actually using Subsys at the time of death due to the timing associated with the patient receiving the prescription and the actual time of death.

    Insys Voluntarily Delayed the Launch of Subsys Until After the Transmucosal Immediate Release Fentanyl (“TIRF”) Risk Evaluation and Mitigation Strategy (“REMS”) Program Was Implemented Due to the Company’s Commitment to Ensuring the Product Would Be Used and Prescribed Appropriately: With respect to recent allegations related to the diversion of SUBSYS, in 2012, the FDA introduced the required TIRF REMS program “to ensure informed risk-benefit decisions before initiating treatment, and while patients are treated to ensure appropriate use of TIRF medicines” and “to mitigate the risk of misuse, abuse, addiction, overdose and serious complications due to medication errors with the use of TIRF medicines.” The TIRF REMS program requires outpatients, HCPs who prescribe to outpatients, pharmacies, and distributors to enroll in the program. TIRF products can be prescribed and dispensed only after physicians and pharmacies have undergone training on the risks and benefits of such products and have enrolled in the TIRF REMS program. This closed distribution system is intended to impede diversion of TIRF products. Notably, although Insys obtained FDA approval of Subsys before the TIRF REMS program commenced, Insys voluntarily delayed the launch of Subsys until after the TIRF REMS program was implemented due to the Company’s commitment to ensuring the product would be used and prescribed appropriately.
    Insys is Not Aware of the FDA Raising Safety Concerns Regarding Subsys: Along with other TIRF REMS product sponsors, Insys provides additional annual reports required by the FDA. These reports provide the FDA with enhanced drug safety surveillance over the use of TIRF products. Notably, the FDA has not requested that Insys make any changes to the Subsys label since launch due to safety concerns, nor has the FDA raised any concerns to Insys regarding the safety profile of Subsys.
    Insys is Committed to Patient Safety and the Recent Allegations are Disingenuous: Insys is committed to patient safety and strives to ensure patient access to Subsys. While Insys does not generally comment on inaccurate and false statements made regarding the Company and its products, Insys finds the recent false accusations and complete misrepresentations of publicly available data concerning the number of deaths associated with the use of Subsys, a product that is helping many patients suffering from breakthrough cancer pain, both shameful and disingenuous, particularly in light of the biased agenda held by the individuals who made these misrepresentations.
    1 FDA regulations define “adverse drug experiences,” to include “adverse event[s] associated with the use of a drug in humans, whether or not considered drug related, including . . . [a]n adverse event occurring in the course of the use of a drug product in professional practice; an adverse event occurring from drug overdose whether accidental or intentional; an adverse event occurring from drug abuse; an adverse event occurring from drug withdrawal; and any failure of expected pharmacological action.” (21 C.F.R. Part 314.80.)

    About Insys Therapeutics, Inc.
    Insys Therapeutics is a specialty pharmaceutical company that develops and commercializes innovative drugs and novel drug delivery systems of therapeutic molecules that improve the quality of life of patients. Using proprietary sublingual spray technology and capabilities to develop pharmaceutical cannabinoids, Insys addresses the clinical shortcomings of existing commercial products. Insys currently markets one product, Subsys® (fentanyl sublingual spray). The Company recently submitted a New Drug Application to the U.S. Food and Drug Administration for Syndros® (dronabinol oral solution), a proprietary, orally administered liquid formulation of dronabinol that Insys believes has distinct advantages over the current formulation of dronabinol in soft gel capsule. Insys is developing a pipeline of sublingual sprays, as well as pharmaceutical cannabidiol.

    Subsys® and Syndros® are registered trademarks of Insys Therapeutics, Inc.

    Forward-Looking Statements
    This release contains forward-looking statements. These forward-looking statements are based on management’s expectations and assumptions as of the date of this press release; actual results may differ materially from those in these forward-looking statements as a result of various factors, many of which are beyond our control. These factors include, but are not limited to risk factors described in our filings with the United States Securities and Exchange Commission, including those factors discussed under the caption “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2014 and subsequent updates that may occur in our Quarterly Reports on Form 10-Q. Forward-looking statements speak only as of the date of this press release and we undertake no obligation to publicly update or revise these statements, except as may be required by law.

    Contact:

    Contact:

    Lisa M. Wilson
    In-Site Communications, Inc.
    T: 212-452-2793
    E: lwilson@insitecony.com

    0 1252

    PHOENIX, Ariz., Dec. 02, 2015 (GLOBE NEWSWIRE) — Insys Therapeutics, Inc. (“Insys”) (INSY) today announced the presenting speakers for its Investor Day to be held on Thursday, December 3, 2015 from 8:30 a.m. to 11:30 a.m. EST at The Pierre Hotel in NYC.

    The Insys executive management team will be joined by several healthcare Key Opinion Leaders. Scientific presentations will be given by:

    Dennis J. Dlugos, MD, MSCE

    Professor of Neurology and Pediatrics at the Perelman School of Medicine at the University of Pennsylvania; Director, Pediatric Regional Epilepsy Program at the Children’s Hospital of Philadelphia (CHOP)

    Jeff Gudin, MD
    Director, Pain and Palliative Care at Englewood Hospital and Medical Center, New Jersey; Clinical Instructor, Anesthesiology at the Icahn School of Medicine at Mt. Sinai

    Douglas Glenn Brust, MD, PhD
    Chief of Staff, Lee Memorial Health System, Fort Myers, Florida

    “We are honored to have these distinguished speakers and practitioners share their insights at the Insys Investor Day,” stated Dr. John Kapoor, Chairman, President and Chief Executive Officer. “We look forward to updating investors on our key development programs including our sublingual spray technology; Syndros® (dronabinol oral solution); pharmaceutical cannabinoids; and Subsys®. We are pleased to have these candidates in development to meet underserved medical needs in oncology, epilepsy, CINV, and pain amongst other areas.”

    The Insys Investor Day is by invitation only for analysts and institutional investors. An RSVP to Lisa Wilson via email at lwilson@insitecony.com is required to attend.

    A live webcast of the Insys Investor Day will be available on the Insys website through the “News and Events” page at www.insysrx.com.

    A replay of the Insys Investor Day webcast will be available approximately two hours following the completion of the event at the aforementioned URL. The archived webcast will be available for 90 days.

    About Insys Therapeutics, Inc.

    Insys Therapeutics is a specialty pharmaceutical company that develops and commercializes innovative drugs and novel drug delivery systems of therapeutic molecules that improve the quality of life of patients. Using proprietary sublingual spray technology and capabilities to develop pharmaceutical cannabinoids, Insys addresses the clinical shortcomings of existing commercial products. Insys currently markets one product: Subsys® (fentanyl sublingual spray). The Company recently submitted a New Drug Application to the U.S. Food and Drug Administration for Syndros® (dronabinol oral solution), a proprietary, orally administered formulation of dronabinol that Insys believes has distinct advantages over the current formulation of dronabinol in soft gel capsule. Insys is developing a pipeline of sublingual sprays, as well as pharmaceutical cannabidiol.

    Subsys® and Syndros® are registered trademarks of Insys Therapeutics, Inc.
    Contact:

    Investor Contact:
    Lisa M. Wilson
    In-Site Communications, Inc.
    Phone: 212-452-2793
    Email: lwilson@insitecony.com

      0 3723

      Why be bullish on marijuana stocks? Besides the obvious opportunity to get involved in an industry that has truly just begun to develop, there are companies in the market that have been methodically carving their own market niche. Companies like GW Pharma and Insys have recognized the opportunity that cannabis presents within the biotech space, and now several companies are working to establish a market leading position within traditional medical marijuana.

      Where many marijuana stock plays tend to be more short term, there’s no denying that a buy and hold strategy can pay off when looking at companies holding a good mix of the right fundamentals, a clear development plan, and a solid investor base to build from.

      We don’t stand behind EVERY marijuana stock as a “long” because the truth is that most of them aren’t. But when you find something during its infancy that’s just beginning to build, it’s important to pay close attention. The handful of “longs” that we’ve called out have all gone on to post significant gains over several months. One of last year’s “long” calls was CannaGrow Holdings Inc. (CGRW). At the time we called it out in mid-late October, we said we thought it would fit the mold of a strong candidate for “buy and hold” potential. Clearly a multi month move from $0.04 to highs of $1.05 suggests that we were on the money with the first run, but where many stocks that have such massive runs tend to fall apart, CGRW has maintained a relatively high level of support compared to where it was trading in October.

      We wanted to take a moment to reiterate that we’re still bullish on CannaGrow for many reasons and we remind you of this now because the company is head and shoulders above where it was last year, from a growth stand-point. Just from the most recent announcements, the Company has laid out a clear play by play since initiating plans for their Buffalo Ranch facility.

      But why is this so much of a focus? Simply put, if you had a shot at GWPH or INSY before they posted trial results and positive corporate updates, would you have been scrambling for a seat at the table and would you have had the foresight to find an opportunity to take advantage of the dips these two stocks had during their current bull runs? If you have bought and held winning stocks before, you know why it’s important to be early and ready to ride out any small storms along the way toward a much bigger gain. The fact is, CGRW has proven to be capable of such a run (last year $0.04 to $1.05) and now the company is on the verge of finally breaking ground on what could prove to be Colorado’s premier growing facility.

      Medical marijuana has taken more of a focus for America’s favor of legalization and it just so happens that greenhouse growing produces more of the resins needed in formulating quality extracts. States like New York and Illinois for example only permit the use of a non-smoke based form of medical use. Over $118million worth of marijuana have already been sold in Colorado during the first quarter of 2015 and the market continues to grow month over month according to sales data. Green house growing is preferred when it comes to extracting the most resin from the cannabis plant and the trend to grow weed in greenhouses has come at a time that warehouse space is becoming more expensive and difficult to find. Since voters approved legalizing marijuana for recreational use in 2012, growers have absorbed more than 1 million square feet of industrial space, according to the industrial Market Trends report by Newmark Grubb Knight Frank. The total space occupied by the industry is more than 4 million square feet.

      The benefits of working with CannaGrow from the perspective of a company like NuGro is that they have someone like Dr. John P. Janovec on board to help with the design and cultivation logistics for a successful growing environment. Dr. Janovec has more than twenty years of experience in the areas of research & development involving botanical and horticultural sciences and has served as the lead investigator of numerous scientific projects supported by governmental agencies, private and non-profit organizations, and private donors.

      This isn’t about hyping anything. The direction of the market is leaning toward more of a medical basis (for now) and we feel that those companies that can achieve a leading roll early will most likely have the greatest potential of capitalizing. Realistically the last thing the company has to do is finally break ground on the Buffalo Ranch site. The Company that CannaGrow is acting as liaison for, NuGro Industries, has obtained a Conditional Use Permit for the land and has also been granted a Land Use Application, which will put things in motion, a lot more quickly.

      The final steps to this have to do with CannaGrow’s ability to finalize the Bennett Roadway improvements and in a recent PR, management stated that Butte Valley Construction LLC is accomplishing this efficiently and is on schedule to be completed by the end of June, barring any inclement weather. On top of this, CannaGrow has engaged Latcon Corp., a licensed general contractor, for the day-to-day oversight of the various trade subcontractors, for services like HVAC, Mechanical, Electrical, Plumbing, Security Systems, Site Grading, and Concrete Foundations.

      Once construction documents have been submitted to the County and the contingent requirements have been satisfactorily completed, Latcon can then apply for the various construction-building permits to be issued which will allow construction activities to begin on Lot 61. So it’s becoming more evident that CannaGrow’s current project is on the verge of breaking ground and we want to be there when it happens.

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