FDA to hold hearing on cannabis products

FDA to hold hearing on potential regulatory pathways for cannabis products

FDA to evaluate cannabis use, Stockwinners

The FDA issued a statement from outgoing Commissioner Scott Gottlieb on new steps to advance the agency’s continued evaluation of potential regulatory pathways for cannabis-containing and cannabis-derived products, in which he stated in part:

“In recent years, we’ve seen a growing interest in the development of therapies and other FDA-regulated consumer products derived from cannabis and its components, including cannabidiol, or CBD…We also recognize that stakeholders are looking to the FDA for clarity on how our authorities apply to such products, what pathways are available to market such products lawfully under these authorities, and how the FDA is carrying out its responsibility to protect public health and safety with respect to such products.”

The FDA is announcing a number of new steps and actions to advance its consideration of a framework for the lawful marketing of appropriate cannabis and cannabis-derived products under its existing authorities, Gottlieb said.

These new steps include:

A public hearing on May 31, as well as a broader opportunity for written public comment, for stakeholders to share their experiences and challenges with these products, including information and views related to product safety;

The formation of a high-level internal agency working group to explore potential pathways for dietary supplements and/or conventional foods containing CBD to be lawfully marketed; including a consideration of what statutory or regulatory changes might be needed and what the impact of such marketing would be on the public health;

Updates to its webpage with answers to frequently asked questions on this topic to help members of the public understand how the FDA’s requirements apply to these products;

and the issuance of multiple warning letters to companies marketing CBD products with “egregious and unfounded claims that are aimed at vulnerable populations.”

Publicly traded companies in the cannabis space include Aphria (APHA), Aurora Cannabis (ACB), CV Sciences (CVSI), CannTrust Holdings (CNTTF), Canopy Growth (CGC), Cronos Group (CRON), General Cannabis (CANN), India Globalization Capital (IGC), MediPharm Labs (MLCPF) and Tilray (TLRY).

STOCKWINNERS

To read timely stories similar to this, along with money making trade ideas, sign up for a membership to Stockwinners.

This article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility.

Cannabis stocks rise amid interest by Coca-Cola

Cannabis stocks rise amid interest by Coca-Cola, opportunities for Shopify

Cannabis stocks rise amid interest by Coca-Cola, Stockwinners
Cannabis stocks rise amid interest by Coca-Cola, Stockwinners

Shares of cannabis stocks are in focus following a report that Coca-Cola (KO) is in talks with Aurora Cannabis (ACBFF) as it eyes the cannabis industry and an analyst note from Keybanc which said Shopify (SHOP) has cannabis potential.

COCA-COLA EYES CANNABIS

Coca-Cola is monitoring the nascent cannabis drinks industry and is in talks with Canadian marijuana producer Aurora Cannabis to develop the drinks, Bloomberg reported Monday.

“We are closely watching the growth of non-psychoactive CBD as an ingredient in functional wellness beverages around the world,” Coca-Cola spokesman Kent Landers said. “The space is evolving quickly. No decisions have been made at this time” Landers added.

The move comes as beverage makers are looking towards cannabis as soda consumption and traditional business slows.

Constellation Brands (STZ, STZ.B) previously announced it will spend $3.8B to increase its stake in Canadian marijuana producer Canopy Growth (CGC) and Molson Coors Brewing (TAP) is starting a joint venture with Quebec’s Hydropothecary to develop cannabis drinks.

In addition, Diageo (DEO) has been holding talks with at least three Canadian cannabis producers regarding a potential deal and Heineken’s (HEINY) Lagunitas label has launched a brand focused on non-alcoholic drinks infused with THC.

SHOPIFY MAY BENEFIT FROM CANNABIS SALES

KeyBanc analyst Monika Garb told investors in a research note on Monday that she is a buyer of Shopify, as the company has “ample” growth opportunities ahead.

She sees potential upside to her above-consensus estimates and expects that recreational sales of cannabis in Canada could be a general merchandise volume and revenue driver further benefiting Shopify’s business momentum.

The analyst said the company has been selected by several Canadian provinces to run their e-commerce sites and in-store point of sale solutions and has also signed deals with private cannabis producers and distributors, including Canopy Growth and Aurora.

Additionally, Garb says Shopify is the best positioned to benefit from growth in emerging brands, citing brands like Rebecca Minkoff and Kyle Cosmetics that already use Shopify. Garb maintained an Overweight rating and $182 price target on shares.

CANNABIS STOCKS

Publicly-traded companies in the space include Cronos Group (CRON), Canopy Growth, Tilray (TLRY), Cannabis Science (CBIS), Innovative Industrial Properties (IIPR) and Aurora Cannabis.

PRICE ACTION:

Aurora Cannabis gained over 16% in Monday’s trading, while Tilray gained 7.3%.


STOCKWINNERS

To read timely stories similar to this, along with money making trade ideas, sign up for a membership to Stockwinners.

This article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility.

Zynerba lower following disappointing results

Zynerba says target blood levels in ZYN001 THC-Prodrug patch study not achieved

Zynerba lower following disappointing results, Stockwinners
Zynerba lower following disappointing results, Stockwinners

Zynerba Pharmaceuticals (ZYNE) announced top line results from a Phase 1 clinical program studying ZYN001, the Company’s patent-protected, pro-drug of tetrahydrocannabinol delivered via a transdermal patch, in healthy volunteers.

The program assessed the safety and pharmacokinetics in single and multiple doses of several formulations of ZYN001.

The top line results of this Phase 1 study indicate that target blood levels of 5 to 15 ng/ml THC were not achieved.

ZYN001 was very well tolerated with minimal skin erythema.

There were no serious adverse events or discontinuations for subjects receiving ZYN001.

As a result of these data, the Company will focus its development efforts and investments on the ZYN002 Fragile X syndrome, developmental and epileptic encephalopathy and adult refractory epilepsy programs.

The company expects that this change will extend its cash runway into the second half of 2019.

This Phase 1 study was a single and multiple dose, placebo-controlled first-in-man study to assess the safety and pharmacokinetics of ZYN001 administered as a transdermal patch to healthy adult subjects.

Several formulations and patch wear times ranging from 24 hours to 14 days were assessed in in 60 healthy subjects who were randomized to ZYN001 or placebo.

ZYNE closed at $9.61, it last traded at $7.60.


STOCKWINNERS

To read timely stories similar to this, along with money making trade ideas, sign up for a membership to Stockwinners.

This article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility.

GW Pharmaceuticals could soar on its epilepsy drug

GW Pharma seen nearing historic approval for cannabinoid epilepsy treatment

GW Pharmaceuticals could soar on its epilepsy drug, Stockwinners
GW Pharmaceuticals could soar on its epilepsy drug, Stockwinners

GW Pharmaceuticals’ (GWPH) cannabis-based epilepsy treatment associated with Lennox-Gastaut syndrome and Davret syndrome, #Epidiolex, received what analyst called a favorable review from Food and Drug Administration staff ahead of an advisory committee meeting scheduled later this week.

Both Goldman Sachs and Leerink argued that the documents bode well for Epidiolex approval by its June 27 PDUFA date.

FDA ADCOM DOCUMENTS

The FDA released its advisory committee meeting briefing documents regarding CBD-OS for the treatment of LGS and DS ahead of the advisory panel vote on Thursday.

According to the documents: “In 3 consecutive Phase 3 studies, CBD-OS added to other AED therapy met the primary endpoint of reduction in seizure frequency in patients with LGS and DS. Doses of CBD-OS at 10mg/kg/day and 20mg/kg/day were superior to placebo at reducing drop seizure frequency, and efficacy was maximized during the 12-week maintenance period once the target dose was achieved in LGS patients.

Similar results were also seen in DS patients treated with CBD-OS 20mg/kg/day. […] The safety and tolerability profile of CBD-OS is predictable, and the potential risks are manageable through the proposed label and medication guide. […] Elevated transaminases were observed more frequently in CBD-OS patients than placebo, and increased AST and increased ALT were the most common reasons for discontinuing CBD-OS treatment.

Therefore, routine liver tests prior to CBD-OS use and periodically during treatment are recommended.

In addition, GW will implement a post-marketing enhanced pharmacovigilance program to monitor the safety profile of CBD-OS, with a focus on liver abnormality reports.

Overall, CBD-OS provides a positive benefit-risk for patients with drug-resistant LGS or DS and can satisfy an unmet need by providing an additional treatment option to reduce the number of seizures in LGS and the first indicated treatment option for DS.” CBD-OS, or cannabidiol oral solution, is the first-in-class antiepileptic drug for the adjunctive treatment of seizures associated with LGS and DS in patients 2 years of age and older.

GW Research, which is a part of GW Pharmaceuticals and operates under Greenwich Biosciences in the U.S., holds the Investigational New Drug application for CBD-OS.

DOCUMENTS SUPPORT APPROVAL

Commenting on the briefing documents, Goldman Sachs analyst Salveen Richter told investors that the “brevity of the relatively benign documents” along with the half day panel duration suggest a likely straightforward meeting.

The analyst noted that there is only one question for discussion – “Is the benefit-risk profile of cannabidiol favorable for the treatment of seizures associated with Lennox-Gastaut syndrome and Dravet syndrome in patients 2 years of age and older?” – which could support a broad label in “seizures associated with LGS/DS” and in children/adults.

Thus, Richter believes these documents should bode well for Epidiolex approval by the June 27 date assigned by the FDA.

The analyst recommended owning GW Pharmaceuticals shares into the Epidiolex launch, assuming widespread off-label use per physician feedback and optionality from Epidiolex Phase 2/3 Part A data in infantile spasms in the second quarter of 2018.

He reiterated a Buy rating and $177 price target on the stock.

Meanwhile, his peer at #Leerink told investors in a research note of his own that his review of the meeting materials suggests that the FDA is likely to approve Epidiolex, and the outcome of the advisory panel vote on April 19 should be positive.

Additionally, analyst Geoffrey Porges argued that Epidiolex’ review bodes well for Zogenix’ (ZGNX) ZX0008. The latter’s unprecedented efficacy in reducing seizures will allow it to gain significant market share within its first 12 months of approval, he contended.

PRICE ACTION

Shares of GW gained about 11% yesterday following the release of the documents, though they have given back about 2% in Wednesday’s trading to trade near $131 per share.


STOCKWINNERS

To read timely stories similar to this, along with money making trade ideas, sign up for a membership to Stockwinners

This article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility.

FDA proposed rules to lower nicotine in cigarettes

FDA takes steps to reduce smoking rates by lowering nicotine in cigarettes

FDA proposed rules to lower nicotine in cigarettes. Stockwinners.com
FDA proposed rules to lower nicotine in cigarettes

FDA Commissioner Scott Gottlieb earlier today issued a statement on steps to “dramatically reduce smoking rates by lowering nicotine in combustible cigarettes to minimally or non-addictive levels.”

The FDA issued an advance notice of proposed rulemaking, or ANPRM, to explore a product standard to lower nicotine in cigarettes to minimally or non-addictive levels.

“This new regulatory step advances a comprehensive policy framework that we believe could help avoid millions of tobacco-related deaths across the country,” Gottlieb said.

The ANPRM provides a “wide-ranging review of the current scientific understanding about the role nicotine plays in creating or sustaining addiction to cigarettes and seeks comments on key areas, as well as additional research and data for public review, as we continue our consideration of developing a nicotine product standard,” he added.

He went on, “We believe the public health benefits and the potential to save millions of lives, both in the near and long term, support this effort. Notably, new estimates included in the ANPRM that are being published in the New England Journal of Medicine evaluate one possible policy scenario for a nicotine product standard.

If this scenario were implemented, this analysis suggests that approximately 5 million additional adult smokers could quit smoking within one year of implementation.”

Publicly traded companies in the space include Altria Group (MO), British American Tobacco (BTI) and Philip Morris (PM). A beneficiary could be 22nd Century Group (XXII). The latter has a patent on a modified tobacco plant with 95% less nicotine than ordinary tobacco plants.


STOCKWINNERS

To read timely stories similar to this, along with money making trade ideas, sign up for a membership to Stockwinners

This article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility.

Cannabis in California

Names to watch ahead of California marijuana legalization

Names to watch ahead of California marijuana legalization. Stockwinners.com
Names to watch ahead of California marijuana legalization

As recreational use of marijuana is set to become legal in California on the first day of the year, the space seems to be getting more and more attention, with a new marijuana ETF starting to trade this week and Constellation Brands (STZ) taking a stake in a Canadian medical marijuana producer earlier this year.

CANNABIS IN CALIFORNIA

For people residing in California, the New Year means they will able to buy recreational marijuana as it is set to become legal in the state starting January 1, a date that dispensaries and consumers have had in their sights on since Proposition 64 made it the official opening of the adult-use market in California.

In keeping with state rules, retailers will be able to sell or deliver cannabis between 6am and 10pm.

NAMES TO WATCH

Among the publicly traded names in the space is Innovative Industrial Properties (IIPR), a REIT that owns dispensary properties.

Last year, NYSE became the first major exchange to list a cannabis company with its acceptance of Innovative Industrial Properties’ initial public offering.

Constellation Brands seems to also be interested in the blossoming cannabis industry as the company bought a minority stake in a Canadian medicinal marijuana producer.

In October, Constellation announced it paid C$245M for a 9.9% interest in Canopy Growth, a Canadian provider of medicinal cannabis products.

Constellation, which is looking to develop cannabis products that don’t contain alcohol, does not expect to sell products in the U.S. before marijuana is nationally legalized but may begin to sell products in Canada, where such products are expected to be legalized by 2019.

Earlier this week, ETF Managers Group announced that MJX, the ETFMG Alternative Harvest ETF, was live and available for trading on the NYSE Arca.

This fund is one of the first of its kind available to U.S. investors and is designed to replicate the Prime Alternative Harvest Index, which tracks companies likely to benefit from the increasing global acceptance of various uses of the cannabis plant.

This includes treatments from innovative medicinal breakthroughs involving the plant’s unique properties.

PRICE ACTION

In Wednesday’s trading, shares of Constellation Brands are fractionally down to $224.95, while Innovative Industrial Properties is up nearly 5% to $27.24.


STOCKWINNERS

To read timely stories similar to this, along with money making trade ideas, sign up for a membership to Stockwinners

This article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility.