22nd century action (XXII): why the price has jumped

  • 22nd Century Group Inc’s (NASDAQ: XXII) share price rose 38.6% in the previous trading session. That’s why it happened.

The stock price of 22nd Century Group Inc (NASDAQ: XXII) – a leading agricultural biotechnology company focused on reducing the harm of tobacco, reducing nicotine tobacco, and improving health and wellness- be thanks to modern plant science – rose 38.6% in the previous trading session. Investors responded to 22nd Century Group, Inc. (Nasdaq: XXII) by announcing today that the United States Food and Drug Administration (FDA) has cleared VLN King and VLN Menthol King reduced-content cigarettes for sale. nicotine as modified risk tobacco products (MRTP)).

And in doing so, the agency found that VLN – which smokes, tastes and smells like a conventional cigarette but contains 95% less nicotine than highly addictive conventional cigarettes – helps reduce nicotine exposure and consumption for smokers. who use them. .

The FDA has cleared VLN for sale with the following MRTP claims:

– “Helps you smoke less. “

– “95% less nicotine.

– “Helps reduce your nicotine intake.” “

– “… Drastically reduces your nicotine consumption.

And the FDA’s decision to allow the company’s MRTP claims and require the additional “Helps you smoke less” claim on every VLN pack and in every VLN advertisement where one of the other permitted claims is also used. was based on a large body of science. consisting of dozens of independent scientific and clinical studies using 22nd century Nicotine Reduced Tobacco (RNC) cigarettes. These studies – which were funded primarily by the FDA, National Institutes of Health (NIH), and other US federal government agencies, as well as studies funded by 22nd Century – show that smokers who use RNC cigarettes, even those who use RNC cigarettes. who do not intend to quit smoking at the start of studies, reduce their exposure to and dependence on nicotine, smoke fewer cigarettes per day, increase their number of smoke-free days and double their quit attempts – the all with little or no signs of nicotine withdrawal symptoms or compensatory smoking.

VLN is also the first and only combustible cigarette to hit the market that meets the FDA’s proposed nicotine cap for conventional cigarettes in its Comprehensive Tobacco and Nicotine Regulatory Plan as well as its mandate to reduce fuel consumption. the nicotine content recently proposed by New Zealand.

The FDA reiterated in its announcement that it was “committed to advancing the rule-making process to ban menthol as a characterizing flavor in cigarettes and all characterizing flavors in cigars and remains on the right track. way to publish proposed rules in spring 2022 ”and that VLN King and VLN Menthol King cigarettes“ could help addicted cigarette smokers reduce their nicotine consumption and the number of cigarettes they smoke per day ”.

The FDA’s decision is further supported by research projecting that an industry product standard to reduce the nicotine content in cigarettes to minimal or non-addictive levels would dramatically alter the trajectory of cigarette addiction. – which is the leading cause of preventable illness and death in the United States. million adult smokers would quit within a year of implementation, more than 33 million people would avoid becoming regular smokers, and more than eight million premature tobacco deaths could be prevented. And with nearly half a million Americans dying from smoking and over $ 300 billion spent annually on smoking-related illnesses, there is a clear and urgent need for substantial change in the tobacco industry. tobacco.

22nd Century is ready to supply the market with RNC tobacco and finished products such as VLN to enable 22nd Century and other manufacturers to comply with nicotine capsules offered in the United States, New Zealand and other countries. other countries as they embrace this innovative and highly efficient technology. tobacco harm reduction approach first proposed by WHO in 2015. And 22nd century herbal technology and products are superior to expensive extraction and similar denicotinization technologies, as these technologies typically use chemicals which remove not only nicotine but also the compound flavor and aroma, resulting in a product which has been deemed unacceptable to smokers as it provides no smoking satisfaction.

In contrast, 22nd century reduced nicotine tobacco naturally grows with very low levels of nicotine, resulting in products that smoke, taste and smell like conventional cigarettes but contain 95% less nicotine than highly addictive conventional cigarettes. And this is essential in creating an acceptable solution and an “exit ramp” for current smokers looking to change their relationship with nicotine.

KEY QUOTES:

“Today’s decision to authorize VLN’s MRTP application puts the FDA and 22nd Century together at the forefront of tobacco industry transformation. With 60% of adult smokers in our US market research telling us they are likely to try VLN®, this is a game changer for the 22nd century, the tobacco industry, public health and adult smokers seeking change their relationship to nicotine – the addictive chemical found in all tobacco products. It is the first and quite possibly the only combustible cigarette to carry the FDA MRTP designation. The FDA’s Decision to Require the Additional “Helps You Smoke Less” Claim Along with Our Sought-After Claim “95% Less Nicotine” Gives Adult Smokers A Clear Reason To Replace Their Highly Addictive, Conventional Cigarettes With VLN ®. “

“Having obtained this marketing order from the FDA, we are fully prepared to launch VLN with selected retail and marketing partners in our pilot markets in the United States over the next 90 days and on the first in several global markets by the end of the first quarter of 2022. We are also in discussions with other business, marketing and strategic partners to increase VLN’s sales in the United States and internationally, notably through a potential license of our technology to facilitate the broader industry transition to RNC products. We will provide further details on strategic partners and the deployment of VLN in the coming months. “

“We believe that today’s announcement by the FDA is a clear indication that the FDA is moving forward with its plan to tackle the incredible harms caused by smoking. This plan includes the authorization of less toxic tobacco products such as electronic cigarettes and other non-combustible products as well as a nicotine cap of 0.5 mg of nicotine per gram of tobacco in combustible tobacco products. This level of nicotine content, which the FDA has described as “low or non-addictive”, was already achieved in the 22nd century in its VLN products. “

“As the FDA is also seeking to ban menthol in highly addictive cigarettes, we expect the FDA to approve our VLN Menthol cigarettes, which offer little appeal to young and old smokers due to their reduced content. nicotine, to remain on the market to provide an exit ramp for adult smokers of menthol cigarettes.

– James A. Mish, CEO of 22nd Century Group

“Our mission is to find ways to stop tobacco-related illness and death. We know that three in four adult smokers want to quit, and data on these products shows that they can help addicted adult smokers quit highly addictive burnt cigarettes. Having options like those products licensed today, which contain less nicotine and are reasonably likely to reduce nicotine addiction, can help adult smokers. If adult smokers were less dependent on burnt cigarettes, they would likely smoke less and could be exposed to fewer harmful chemicals that cause tobacco-related illness and death.

– Mitch Zeller, JD, Director of the Center for Tobacco Products at the FDA

“The data also showed that it is reasonably likely that the use of these products will reduce nicotine dependence, which should lead to long-term reductions in exposure to smoking-related toxins associated with morbidity and mortality by reducing smoking. Published studies have shown that a significant reduction in the number of cigarettes smoked per day is associated with a lower risk of lung cancer and death, with a greater reduction in the number of cigarettes per day resulting in a lower risk. Additionally, as required for clearance, the FDA found that the applications supported consumers’ understanding of claims that VLN® cigarettes contain much lower levels of nicotine than other cigarettes.

– FDA

Disclaimer: This content is intended for informational purposes. Before you make an investment, you need to do your own analysis.

Eleanor C. William