US FDA Breakthrough Therapy Designation for Mushrooms Creating Big Opportunity

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Dec 05, 2019, 10:30 ET

PALM BEACH, Florida, Dec. 5, 2019 /PRNewswire/ -- For the second year, the U.S. FDA designated psilocybin, a compound found in hallucinogenic mushrooms, as a "breakthrough therapy" for the treatment of major depressive disorder (MDD). "This designation, which is designed to expedite the development and review of drugs—given out only for therapies that have shown strong preliminary evidence in treating serious medical conditions—puts new pharmaceuticals on a fast track for approval and offers "intensive guidance" from the FDA," reports Popular Science. Even Researchers at New York University found psilocybin mushrooms caused a "rapid and sustained" reduction in anxiety and depression in patients with cancer, as reported by the Financial Post. That's all opening a range of opportunity for companies that have already established launching cannabis products including The Yield Growth Corp. (CSE:BOSS) (OTCQB:BOSQF), HEXO Corporation (NYSE:HEXO) (TSX:HEXO), Trulieve Cannabis Corp. (CSE:TRUL)(OTCQX:TCNNF), The Green Organic Dutchman (TSX:TGOD)(OTCQX:TGODF), and OrganiGram Holdings Inc. (NASDAQ:OGI) (TSX-V:OGI).

The Yield Growth Corp. (CSE:BOSS)(OTCQB:BOSQF) BREAKING NEWS: The Yield Growth Corp. just announced that its subsidiary Flourish Mushroom Labs Inc. has started initial consumer tasting trials for four organic mushroom coffees using a unique blend of freshly ground coffee beans and various mushroom formulations. "Great emphasis has been given to selecting quality ingredients including mushrooms that exhibit the highest level of active components, which are assayed in the laboratory to assure efficacy and safety," says Vivek Taneja, Flourish Mushroom Labs' VP, Operations. "The consumer tasting trials will involve 100 participants and will take one month to complete and compile results. If results are satisfactory then the next stage of development will commence." The newly developed line of coffees contain the mushroom varieties Lion's Mane, Reishi , Turkey Tale, Cordyceps and Chaga. Lion's Mane is known to be a powerful brain food that Healthline.com suggests supports memory, focus and cerebral function. Healthline.com also states that Reishi mushrooms may help boost the immune system, reduce stress, while Turkey Tail is shown to be a powerful antioxidant that improves gut bacteria balance. Cordyceps, according to an article from the US National Library of Medicine, have shown to enhance athletic performance and support longevity. Chaga extracts, according to www.healthline.com, have been used in Russia and Northern European countries mainly to boost immunity and overall health. These extracts have been used to treat certain cancers, diabetes and heart disease and to lower blood sugar and cholesterol.

"Our research team has collected scientific information, including biological and pharmacological studies related to the chemical constituents and curative effects of medicinal mushrooms from various journals in developing our mushroom formulas These herbs have been used in traditional Chinese and Ayurvedic medicine for thousands of years as food for optimum health," says Bhavna Solecki, VP, Research and Development at Flourish Mushroom Labs.

Other related developments from around the markets include:

HEXO Corporation (NYSE:HEXO) (TSX:HEXO) just launched Original Stash, its new value brand, in Ontario on Black Friday. Adult-use consumers in Ontario will be able to purchase 28 grams (1 oz) of quality dried cannabis flower at black market prices, retailing at $140 ($5 per gram), including taxes. "HEXO is disrupting the black market this Black Friday," said Sebastien St-Louis, CEO and co-founder of HEXO. "We are committed to playing a valuable role in eliminating the illicit market and in protecting public health and safety. That's why we are pleased to continue rolling out Original Stash across Canada, providing consumers with a quality product at a low price. Our experience with the launch of Original Stash in October demonstrates that there is a strong demand for this type of product." HEXO is launching OS.220, the second dried flower product to roll out from the Original Stash brand, in Ontario. OS.220 is a mid-THC Indica flower blend of two strains, available in a 28 g (1 oz) format. The Ontario Cannabis Store is poised to make Original Stash available on its webstore and to all licensed retailers in the province, who can in turn choose to carry the brand. HEXO's Original Stash will be the first brand to be featured as part of the Ontario Cannabis Store's inaugural homepage holiday campaign, in conjunction with Black Friday. "Original Stash is providing consumers with 'quality weed at legit prices'," added St-Louis. "Consistent, reliable and controlled products like this can play a major role in achieving the goals we set out nationally by legalizing cannabis just over a year ago: eliminating the illicit market and protecting public health and safety. We look forward to continuing to work with our regulators and partners to deliver on those objectives."

Trulieve Cannabis Corp. (CSE:TRUL)(OTCQX:TCNNF) announced that CEO Kim Rivers will be featured on a presenting panel Multi-State Operators take on Medicinal Cannabis speaking with other leading cannabis executives in the healthcare sector at Piper Jaffray's 31^st Annual Healthcare Conference at 4:00 p.m. EST on Tuesday, December 3^rd, 2019. This two-day event is being held in New York City, and will bring together institutional investors and nearly 300 leading public and private companies in various health care services sectors such as biotechnology and specialty pharmaceuticals. In addition, Ms. Rivers is scheduled to speak on the Licensing: Ins and Outs – Ensuring Continued Compliance in a Changing Regulatory Landscape panel at the MJ Biz Conference at 10:30 a.m. PST on Thursday, December 12^th, 2019 in Las Vegas.

The Green Organic Dutchman (TSX:TGOD)(OTCQX:TGODF) just announced that it has entered into an amending agreement with Canaccord Genuity Corp. to increase the size of its previously announced bought deal financing. Pursuant to the revised terms of the offering, the Underwriter has agreed to purchase, on a bought deal basis, an aggregate of 32,000,000 units (the "Units") at a price of C$0.75 per Unit for aggregate gross proceeds to TGOD of $24,000,000. Each Unit will consist of one common share of the Company and one-half of one Common Share purchase warrant. Each Warrant will be exercisable to acquire one Common Share for a period of 36 months following the closing of the Offering at an exercise price of C$1.00 per Warrant Share. The Company has granted the Underwriter an option to purchase up to an additional 4,800,000 Units at a price of C$0.75 per Unit, exercisable at any time, for a period of 30 days after and including the Closing Date, which, if exercised, would result in additional gross proceeds of $3,600,000. The Over-Allotment Option is exercisable to acquire Units and/or Warrants at the discretion of the Underwriter.

OrganiGram Holdings Inc. (NASDAQ:OGI)(TSX-V:OGI) announced its results for the fourth quarter and fiscal year ended August 31, 2019. "Our 2019 results reflected a successful year for Organigram. Not only did we report strong top-line growth and establish an enviable national market share position in Canada, we generated positive adjusted EBITDA - one of the key measures we use to evaluate our performance," said Greg Engel, Chief Executive Officer. "In 2019, we increased staffing and capacity to meet forecasted demand and maintain inventory in the market. Industry structural issues have challenged supply and demand dynamics in the short-term but we believe the growth opportunity in the Canadian cannabis market remains intact. "As we were one of the first success stories to supply the market in the early days of legalization, we have had visibility for some time now on ultimate sell through to consumers and have adapted our production mix and product strategy to align with our understanding of emerging consumer preferences. We have great conviction in our strategy and ability to onboard the new retail store openings and to launch a portfolio of edible and derivative products appealing to adult consumers. With our state-of-the-art indoor facility and leading cultivation practices, strong brand equity, in-house expertise and strategic partnerships and a focus on cost management, we are well-positioned for the long term."

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