22nd Century Group Inc. (NYSEMKT:XXII)

22nd Century Group Inc. (NYSEMKT:XXII) In Discussion With FDA Over Product Approval

22nd Century Group Inc. (NYSEMKT:XXII)

Shares of 22nd Century Group Inc. (NYSEMKT:XXII) were unchanged in Monday’s trading session as the company continued to push for regulatory approval of its smoking cessation product X-22. The company is also fresh from inking a partnership with the University of Virginia for the use of Industrial Hemp to clean up and reclaim polluted lands.

22nd Century Group Inc. (NYSEMKT:XXII) is currently trading in a $1.72-$2.07 trading range after a pull-back from highs of $2 per share last week. Immediate support on the stock is at $1.40.

The plant biotechnology company boasts of a proprietary technology that enables the adjusting of levels of nicotine and other nicotinic alkaloids in tobacco plants through genetic engineering. The company also develops smoking cessation products.

FDA Meeting

22nd Century Group Inc. (NYSEMKT:XXII) recently participated in a meeting with a multi discipline review team at the Centre for Drug Evaluation and Research. The meeting sought to consider whether 22nd Century Group’ X-22 smoking product can be approved for use in helping people quit smoking. The company has since been asked to carry out two parallel Phase 3 clinical trials, to prove whether the product can result in a robust quit rate in smoking, compared to existing cessation products.

“We look forward to working collaboratively and closely with the FDA during 2017 regarding the approval of important aspects of the two parallel, Phase III clinical trials on X-22 that we intend to commence in the first half of 2018,” said CEO, Henry Sicignano III.

Trials will begin as soon as 22nd Century Group gets clarification on whether to use its own funds for the trials or source funds from third parties.

Environmental Cleanup

Separately, 22nd Century Group Inc. (NYSEMKT:XXII) and the University of Virginia plan to use a variety of industrial hemp to clean abandoned mines as well as polluted landscapes. The biotechnology company has already developed proprietary hemp plants that the two plan to use in phytoremediation. The hemp plants are designed to absorb toxins, metals as well as soil contaminants.

22nd Century Group Inc. (NYSEMKT:XXII) Vice President for plant biotechnology, Dr. Paul Rushton, expects the cleanup process to validate the company’s technology in addition to opening up new lucrative markets.

“We are enthusiastic about the prospect of applying our biotechnology expertise to a challenging environmental problem,” said Dr. Rushton.

I have no positions in any of the stocks mentioned, and have no plans to initiate any positions within the next 72 hours. All information, including any data, is provided without any guarantees of accuracy.

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About the author: Monica has an undergraduate degree in Accounting and an MBA she earned – with Honors. She has six years of experience in the financial markets and has been an analyst for the past two years.

22nd Century Group Inc (NYSEMKT:XXII)

22nd Century Group Inc (NYSEMKT:XXII) Inks Deal

22nd Century Group Inc (NYSEMKT:XXII)

22nd Century Group Inc (NYSEMKT:XXII) is a cutting edge plant biotechnology company with a novel mission – to develop a tobacco and cannabis plant with low levels of nicotine. Today the company released what many expected to be received as good news, but after a brief price gain, the shares eventually gave up their gains and closed unchanged. Over 5.3 million shares of XXII were traded which is over five times their listed 30-day, daily average volume of 966,000.

22nd Century Group Inc (NYSEMKT:XXII) released news today that it had enetered a collaborative agreement with The Dent Neurosciences Research Center (DNRC). DNCR will provide magnetic resonance imaging to image the brains of smokers as trial participants smoke Very Low Nicotine (VLN) cigarettes, developed and produced by 22nd Century Group Inc (NYSEMKT:XXII), or conventional cigarettes.

The trial is being carried out after clinical trials have produced results that suggest a significant physiological change occurs in a smokers brain as little as six days after switching to a VLN cigarette. The outcome of the imaging is hoped to identify changes in the brain that may correlate with nicotine addiction. A non-invasive marker of addiction status in brain activity could prove invaluable for future nicotine addiction studies.

Dr. Paul Rushton, 22nd Century’s Vice President for Plant Biotechnology stated, “The identification of changes in brain activity associated with smoking our VLN cigarettes compared to smoking regular cigarettes will be an important step forward.”

22nd Century Group Inc (NYSEMKT:XXII) has had ioncreasing annual sales for the past three years. In 2014 sales were reported at $0.50 million, followed by $8.5 million in 2015, and $12.3 million in 2016. Shareholders of XXII have, however, not seen any profits. Since 2015, XXII has had EPS losses. For 2016, the EPS loss was ($-0.15). Share dilution has been of, arguably, larger significance to XXII shareholders. In 2012 29.44 million shares were outstanding. That number has grown every year and in 2016 stood at 79.84 million.

I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. All information, or data, is provided with no guarantees of accuracy.

Don’t miss out! Stay informed on $XXII and receive breaking news on other hot stocks by signing up for our free newsletter!

About the author: Marc has a degree in economics and a MSc. in Finance. Over his 20-year career, Marc has worked for global investment firms in Europe and the United States as an analyst, fund manager, and consultant.