Cannabis stocks were mostly higher on Monday, after the U.S. Food and Drug Administration said it is expediting its effort to create a regulatory framework for CBD with plans to publish a report on its progress by early fall.
Amy Abernathy, acting chief information officer, said in a series of tweets sent on Friday that the agency is “expediting its work to address the many questions about cannabidiol. This is an important national issue with public health impact, and an important topic for American hemp farmers and many other stakeholders.”
The FDA is still working its way through the public comments posted after more than 100 speakers presented at a May 31 public hearing on the subject, she said, urging anyone who still plans to submit information to do so by Tuesday.
CBD, a non-psychoactive ingredient in cannabis, is widely held to have wellness properties and to help treat a range of complaints, from pain management to inflammation to anxiety. But the FDA cannot allow companies to add it to food and beverages, because it’s the main ingredient in the only FDA-approved cannabis-based drug, GW Pharmaceuticals PLC’s Epidiolex, a treatment for severe childhood epilepsy. That makes it a drug in the FDA’s eyes, and means it would require research and trials to determine its efficacy and safety.
1/3 FDA is expediting its work to address the many questions about cannabidiol (CBD). This is an important national issue with public health impact, & an important topic for American hemp farmers and many other stakeholders. pic.twitter.com/XQbXb0KspU
But with many companies anxious to launch products containing CBD, the FDA has come under pressure to devise rules sooner, rather than later. Clinical trials typically take several years to complete. Former FDA Commissioner Scott Gottlieb proposed congressional action to speed things up, based on using very low doses of the substance.
Read now: Cannabis stocks fall after FDA hearing on CBD finds conflicting views of substance
Companies are selling topicals and oils containing CBD, which the FDA is tolerating, as long as they don’t make exaggerated health claims.
See also: One Canopy Growth co-CEO is out, and the other isn’t far behind in major shake-up at world’s largest cannabis company
In company news, Organigram Holdings became the first big weed company to report earnings for its fiscal third quarter. The company surprised with a loss and revenue miss, which it said was related to how Ontario, Canada’s most populous province orders pot and the dearth of retail stores there, as MarketWatch’s Max A. Cherney reported.
Organigram Chief Executive said on the earnings call that the increased costs were due to an ultimately unsuccessful experiment it conducted with how it planted new harvests.
The company posted a net loss of C$10.2 million ($7.8 million), or 7 cents a share, after a profit of C$2.8 million, or 3 cents a share, in the year-ago period. Gross revenue increased nearly ninefold to C$30.4 million, while net revenue excluding excise taxes rose to C$24.75 million ($19.0 million) from C$3.4 million. The FactSet consensus was for a profit of 3 cents and revenue of C$29.7 million. Organigram’s fiscal third quarter ended May 31.
The disappointing numbers sent the stock lower early in the day, but it rebounded in official trade and was last up 3.1%.
CannTrust Holdings shares
edged higher, putting them on track for their first gain in seven sessions. The stock has been clobbered since the Canadian regulator seized more than five metric tons of the company’s cannabis after discovering it had been growing in unlicensed rooms.
The company’s Danish partner, Stenocare A/S
said it received and sold some of the illegal pot. Exporting unlicensed cannabis is an indictable offense, according to Canadian laws.
Mackie Research said it was terminating its coverage of the stock, because it can no longer trust company management. In a note explaining its decision, analysts led by Greg McLeish said Health Canada should crack down hard on the company, because a failure to do so would set a bad precedent for law-abiding companies.
“Management has lost credibility and we now have concerns about the company’s financial accounting,” McLeish wrote. The unlicensed grow happened between October 2018 and March 2019 and raises questions about whether it showed up in inventory and whether it was accounted for. “If it did show up, why didn’t senior management identify a potential problem?” the analyst asked.
Aurora Cannabis shares
rose 3.2%, after the company said it has won Health Canada licenses for outdoor growing at two Canadian sites in Quebec and British Columbia. The sites “will be used for cultivation research to develop new technology, genetics and intellectual property in order to drive sustainable, high-quality outdoor production.”
See: Zenabis fought short-selling financiers in the cannabis industry, but did it win?
shares rose 7.4%, after that company said it has won a license amendment for its entire 1.1 million square feet Port Perry outdoor growing facility. The company’s previous license covered just 292,000 square feet.
Flowr Corp. shares
fell 8.6% after the company said it has received approval for an outdoor grow area with plans to start building 42 greenhouses of about 4,500 square feet in size. Jefferies analyst Ryan Tomkins, who rates the stock at hold, said the timing of the approval is good.
“It means they should have adequate supply to compete in Flower as well as derivatives. Without this approval, current capacity would have likely meant a ‘flower only’ focus near term (with its high quality flower resonating well with consumers it would have been unwise to give up some of this supply to derivatives),” Tomkins wrote in a note to clients.
Elsewhere, Canopy Growth Corp.
the leader by market value, was up 4.1%, Cronos
was up 3.4%, Tilray
was up about 1%, and Valens GroWorks
was 3.1%. Aphria shares
were up 1.2%, Green Growth Brands Inc.
was up 9.5% and MedMen was up 2.2%.
The ETFMG Alternative Harvest ETF
was up 1.2%, with 28 of its 38 constituent stocks moving higher. The Horizons Marijuana Life Sciences ETF
was up 1.6%, with 37 of its 54 constituent stocks falling. The new Cannabis ETF
launched Tuesday by Innovation Shares was up 2.0%.
The Dow Jones Industrial Average
was flat and the S&P 500
was slightly lower.
Don’t miss: People in states where marijuana is legal are eating more salty snacks and ice cream
Ciara Linnane is MarketWatch's investing- and corporate-news editor. She is based in New York.
美国食品和药物管理局( FDA )表示，正加快努力为 CBD 建立监管框架，并计划在秋季初发布一份进展报告。
代理首席信息官艾米•阿贝纳西( Amy Abernathy )上周五在一系列推文中表示，该机构正“加快工作，以解决有关大麻的诸多问题”。这是一个具有公共卫生影响的重要国家问题，也是美国大麻种植农民和许多其他利益相关者的重要议题。”
她说，在5月31日的一次公开听证会上，100多名发言者发表了关于这一问题的演讲后， FDA 仍在努力通过公开发表的评论，敦促仍计划在周二之前提交信息的任何人提交。
CBD 是大麻中的一种非精神活性成分，被广泛认为具有健康特性并有助于治疗一系列的投诉，从疼痛管理到炎症再到焦虑。但 FDA 不能允许公司将其添加到食品和饮料中，因为它是 FDA 批准的唯一一种基于大麻的药物 GW Pharmaceuticals PLC 的 Epidiolex 的主要成分。这使得它成为 FDA 眼中的一种药物，这意味着它需要研究和试验来确定其有效性和安全性。
1/3美国食品和药物管理局正在加快其工作，以解决许多有关大麻（ CBD ）的问题。这是一个具有公共卫生影响的重要国家问题，也是美国大麻养殖户和许多其他利益相关者的一个重要议题。图片。推特。com / XQbXb0KspU
但由于许多公司急于推出含有生物多样性公约的产品， FDA 面临压力，要求尽快制定规则，而不是晚些时候。临床试验通常需要几年才能完成。美国食品和药物管理局前专员斯科特·戈特利布提议国会采取行动，在使用非常低剂量的物质的基础上加快速度。
公司正在销售含有生物多样性公约的外用药物和油，只要他们不做夸大的健康声称， FDA 是容忍的。
另一位是 Canopy Growth 的联席首席执行官，另一位是全球最大的大麻公司的重大重组
在公司新闻中， Organigram Holdings 成为第一家公布第三财季收益的大型除草公司。正如 MarketWatch 的 Max A.Cherney 报道的那样，该公司对亏损和收入损失感到意外。该公司表示，这与加拿大人口最多的省份安大略省的订货量以及那里零售商店的匮乏有关。
在去年同期盈利280万加元（合每股3美分）后，该公司净亏损1020万加元（合780万美元），合每股7美分。总收入增长近9倍，达到3040万加元，而不包括消费税的净收入从340万加元增至2475万加元（1900万美元）。FactSet 的共识是利润为3美分，收入为2970万加元。Organigram 截至5月31日的第三季度。
CannTrust Holdings 股份
该公司的丹麦合作伙伴 Stenokia A / S
奥罗拉（Aurora） Cannabis 股份
见：在大麻行业， Zenabis 与做空的金融家进行了斗争，但它赢了吗？
该公司股价上涨了７．４％，此前该公司表示，已为其位于佩里港（ PortPerry ）的全部１１０万平方英尺户外种植设施赢得许可证修订。该公司之前的许可证仅覆盖29.2万平方英尺。
Flower Corp .股票
该公司表示，已获得批准，将开始建造42座面积约4500平方英尺的温室，随后该公司股价下跌8.6%。Jefferies 分析师 RyanTomkins 对持有的股票进行了评级，他表示批准的时机是好的。
“这意味着他们应该有足够的供应来参与花卉和衍生品的竞争。Tomkins 在给客户的一份报告中写道：“如果没有这一批准，目前的产能可能意味着短期内将“只关注花”( flower only )问题（优质花在消费者中反响良好，放弃某些衍生品供应是不明智的）。
在其他地方， Canopy Growth 公司。
上涨9.5%， MedMen 上涨2.2%。
ETFMG 另类收获 ETF
上涨1.2%，38只成分股中有28只上涨。Horizons Marijuana Life Sciences ETF
上涨1.6%，54只成份股中有37只下跌。新的 Cannabis ETF
Ciara Linnane 是 MarketWatch 的投资和企业新闻编辑。她在纽约。