Thursday, June 22, 2017 10:11:08 AM
22nd Century Receives Guidance from FDA on Phase III Clinical Trials
Today 9:55 AM ET (Business Wire)
22nd Century Group, Inc. (NYSE MKT: XXII), a plant biotechnology company that is a leader in tobacco harm reduction, announced today that on June 20, 2017, the Company and its wholly owned subsidiary, Heracles Pharmaceuticals, participated in a meeting with the multi-discipline review team in the Division of Anesthesia, Analgesia, and Addiction Products at the Center for Drug Evaluation and Research (CDER) of the U.S. Food and Drug Administration (FDA) regarding the Company's Investigational New Drug Application (IND) for 22nd Century's X-22 prescription-based smoking cessation product in development so that it may become available for doctors to prescribe to help their patients to stop smoking. The meeting with the FDA/CDER was very positive and productive. FDA/CDER and the Company will work to reach agreement on the Company's design and implementation of two parallel, Phase III clinical trials to be conducted by the Company in various parts of the United States to show that the Company's X-22 prescription-based smoking cessation product will result in a more robust quit rate in smoking as compared to existing smoking cessation products that are already in the market in the U.S. The Company believes that it will be able to achieve such robust results.
Henry Sicignano, III, President and Chief Executive Officer of 22nd Century Group, stated, "The mission of our Company is to reduce the harm caused by smoking and we believe that we can help smokers to successfully stop smoking through the use of our novel X-22 smoking cessation product in development. 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, subject to our determination of whether we will use funds from a third-party or Company funds to conduct such clinical trials. The public health implications of a smoking cessation product that is more robust in effectiveness than other existing smoking cessation products is enormous. We look forward to continuing to work closely with the FDA on this very important public health matter."
About 22nd Century Group, Inc.
Recent XXII News
- Form 8-K - Current report • Edgar (US Regulatory) • 05/10/2024 09:22:05 PM
- Form EFFECT - Notice of Effectiveness • Edgar (US Regulatory) • 05/10/2024 04:15:19 AM
- Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 05/09/2024 08:30:44 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/15/2024 09:30:52 PM
- Form SC 13G - Statement of acquisition of beneficial ownership by individuals • Edgar (US Regulatory) • 02/14/2024 09:10:59 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/13/2024 09:30:25 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 01/25/2024 01:30:13 PM
- Form DEFA14A - Additional definitive proxy soliciting materials and Rule 14(a)(12) material • Edgar (US Regulatory) • 01/24/2024 09:31:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 01/24/2024 09:30:18 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/09/2024 01:04:11 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 12/28/2023 09:30:31 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 12/21/2023 10:02:41 PM
- 22nd Century Secures $3.2 Million to Date in Warrant Exchange Transaction • GlobeNewswire Inc. • 12/04/2023 12:07:00 PM
- Form PRE 14A - Other preliminary proxy statements • Edgar (US Regulatory) • 12/01/2023 10:18:00 PM
- Pharma Stock Up Big After Second Major Announcement This Week • AllPennyStocks.com • 11/29/2023 03:55:00 PM
- Pharma Stock Up Big After Second Major Announcement This Week • AllPennyStocks.com • 11/29/2023 03:55:00 PM
- 22nd Century Appoints Larry Firestone as Chairman and CEO • GlobeNewswire Inc. • 11/29/2023 12:07:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 11/27/2023 09:56:49 PM
- 22nd Century Group Enters into Agreement to Sell Hemp/Cannabis Franchise • GlobeNewswire Inc. • 11/27/2023 09:44:27 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 11/13/2023 11:01:36 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 11/08/2023 10:19:32 PM
- 22nd Century Group Continues VLN® Expansion, Now Retailing in More Than 5,100 Stores • GlobeNewswire Inc. • 11/08/2023 06:15:00 PM
- 22nd Century Group (XXII) Expands Reduced Nicotine Content Tobacco IP with Latest Technology License • GlobeNewswire Inc. • 11/07/2023 01:45:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 11/06/2023 12:30:19 PM
- 22nd Century Group (XXII) Reports Third Quarter 2023 Financial Results • GlobeNewswire Inc. • 11/06/2023 12:30:00 PM
Avant Technologies Equipping AI-Managed Data Center with High Performance Computing Systems • AVAI • May 10, 2024 8:00 AM
VAYK Discloses Strategic Conversation on Potential Acquisition of $4 Million Home Service Business • VAYK • May 9, 2024 9:00 AM
Bantec's Howco Awarded $4.19 Million Dollar U.S. Department of Defense Contract • BANT • May 8, 2024 10:00 AM
Element79 Gold Corp Successfully Closes Maverick Springs Option Agreement • ELEM • May 8, 2024 9:05 AM
Kona Gold Beverages, Inc. Achieves April Revenues Exceeding $586,000 • KGKG • May 8, 2024 8:30 AM
Epazz plans to spin off Galaxy Batteries Inc. • EPAZ • May 8, 2024 7:05 AM