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The Economist· 2025-07-25 13:40
Young Europeans are on a straighter path than their parents were. But the result is that revenues from smoking and drinking are down by around a fifth as a share of GDP in the past decade or so https://t.co/aATZRcYvCS ...
Achieve Life Sciences to Announce Second Quarter Financial Results and Host Conference Call and Webcast on August 7, 2025
Globenewswire· 2025-07-24 12:30
SEATTLE and VANCOUVER, British Columbia, July 24, 2025 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage specialty pharmaceutical company focused on the global development and commercialization of cytisinicline as a treatment of nicotine dependence for smoking cessation, today announced it will report its second quarter 2025 financial results and provide a corporate update on the cytisinicline development program on Thursday, August 7, 2025, at 8:30 AM EDT. To access the webcast, ...
France says 'au revoir' to smoking in parks and beaches
NBC News· 2025-07-01 12:39
It's a bit too much doing this kind of law because like it's a bit over protecting children also like I think it's I don't want to take a general discussion but for me it's like you have to do um better job like in uh make the the the people the children know what is smoke, know why it's. ...
Achieve Life Sciences Announces Closing of Public Offering of Common Stock and Partial Exercise of Underwriters' Option to Purchase Additional Securities
Globenewswire· 2025-06-30 23:52
Core Viewpoint - Achieve Life Sciences, Inc. has successfully closed a public offering of 15 million shares of common stock, raising gross proceeds of $45 million to advance the development of cytisinicline for nicotine dependence treatment [1][2]. Company Overview - Achieve Life Sciences is a late-stage specialty pharmaceutical company focused on developing and commercializing cytisinicline as a treatment for nicotine dependence, with a New Drug Application submitted to the FDA in June 2025 [5]. - The company has completed two Phase 3 studies and an open-label safety study for cytisinicline, and has also conducted a Phase 2 study for vaping cessation [5]. Product Information - Cytisinicline is a plant-based alkaloid that interacts with nicotinic acetylcholine receptors in the brain, aimed at reducing nicotine cravings and the satisfaction derived from nicotine products [7]. - Approximately 29 million adults in the U.S. smoke combustible cigarettes, and tobacco use is the leading cause of preventable death globally, with over 8 million deaths annually [6]. - There are currently no FDA-approved treatments specifically for nicotine e-cigarette cessation, highlighting a critical need that cytisinicline aims to address [6]. Financial Details - The public offering included 15 million shares at a price of $3.00 per share, along with warrants to purchase up to 16,766,666 additional shares [1]. - Proceeds from the offering will be used for advancing cytisinicline towards FDA marketing approval and for general corporate purposes [2].
Achieve Life Sciences Announces Pricing of $45.0 Million Underwritten Public Offering
Globenewswire· 2025-06-27 03:43
Core Viewpoint - Achieve Life Sciences, Inc. is conducting a public offering of 15 million shares of common stock and accompanying warrants at a price of $3.00 per share, aiming to raise approximately $45 million to support the development of cytisinicline for nicotine dependence treatment [1][4]. Company Overview - Achieve Life Sciences is a late-stage specialty pharmaceutical company focused on developing and commercializing cytisinicline as a treatment for nicotine dependence and smoking cessation [7]. - The company submitted a New Drug Application to the FDA for cytisinicline in June 2025, based on successful Phase 3 studies and an open-label safety study [7]. Offering Details - The public offering includes 15 million shares and warrants, with an additional 2.25 million shares available for underwriters to purchase [1][3]. - Each common warrant can be exercised for common stock at $3.00 or for pre-funded warrants at $2.999, expiring five years from issuance [2]. Financial Aspects - The gross proceeds from the offering are expected to be around $45 million, which will be used for advancing cytisinicline towards FDA approval and for general corporate purposes [4]. - The offering is expected to close around June 30, 2025, pending customary closing conditions [3]. Market Context - There are approximately 29 million adult smokers in the U.S., with tobacco use being the leading cause of preventable death [8]. - Cytisinicline has been granted Breakthrough Therapy designation by the FDA to address the need for effective treatments for nicotine e-cigarette cessation, as there are currently no FDA-approved options for this indication [9].
Achieve Life Sciences Announces Proposed Underwritten Public Offering
Globenewswire· 2025-06-26 20:03
Company Overview - Achieve Life Sciences, Inc. is a late-stage specialty pharmaceutical company focused on the global development and commercialization of cytisinicline as a treatment for nicotine dependence and smoking cessation [5] - The company submitted its New Drug Application to the FDA for cytisinicline in June 2025, based on two completed Phase 3 studies and a fully enrolled open-label safety study [5] Offering Details - Achieve Life Sciences announced a proposed underwritten public offering to sell shares of its common stock and accompanying common warrants, with an option for underwriters to purchase an additional 15% of the shares [1][2] - The proceeds from the offering are intended to fund the advancement of cytisinicline through potential FDA marketing approval and for working capital and general corporate purposes [2] Market Context - Approximately 29 million adults in the U.S. smoke combustible cigarettes, with tobacco use being the leading cause of preventable death, responsible for over eight million deaths globally and nearly half a million in the U.S. annually [6] - There are around 17 million adults in the U.S. who use e-cigarettes, with no FDA-approved treatments specifically for nicotine e-cigarette cessation, highlighting a critical need for effective solutions [7] Product Information - Cytisinicline is a plant-based alkaloid with a high binding affinity to nicotinic acetylcholine receptors, believed to aid in treating nicotine addiction by reducing craving symptoms and the satisfaction associated with nicotine products [8][9] - Cytisinicline has been granted Breakthrough Therapy designation by the FDA to address the urgent need for treatments for nicotine dependence [7]
Achieve Life Sciences Announces Submission of NDA to FDA for Cytisinicline as a Treatment of Nicotine Dependence for Smoking Cessation
Globenewswire· 2025-06-26 20:01
Core Insights - Achieve Life Sciences has submitted a New Drug Application (NDA) to the FDA for cytisinicline, marking the first new pharmacotherapy option for nicotine dependence in two decades [1][4] - Cytisinicline has shown efficacy and safety in two large Phase 3 trials, ORCA-2 and ORCA-3, demonstrating significantly higher abstinence rates compared to placebo [2][3] - The public health burden of smoking affects nearly 29 million adults in the U.S., with smoking-related illnesses causing nearly half a million deaths annually [2][5] Company Overview - Achieve Life Sciences is a late-stage specialty pharmaceutical company focused on developing cytisinicline for nicotine dependence treatment [4] - The company has also completed a Phase 2 study for vaping cessation and has received Breakthrough Therapy designation from the FDA for cytisinicline [6][4] Product Details - Cytisinicline is a plant-based alkaloid that interacts with nicotinic acetylcholine receptors, potentially reducing nicotine cravings and satisfaction from nicotine products [7] - The NDA submission is supported by data from over 2,000 clinical trial participants, indicating a well-tolerated safety profile [1][2]
22nd Century Announces Operation 100 – A 100mm VLN® Cigarette Designed to Reach Even More Adult Smokers Who Want to Reduce Their Nicotine Consumption
GlobeNewswire News Room· 2025-06-26 12:00
100mm Cigarettes Comprise Approximately Half the U.S. Market, Giving Even More Smokers a Familiar Choice as They Seek Ways to Change Their Smoking Behavior First FDA Submission Planned for Q4 2025 MOCKSVILLE, N.C.,, June 26, 2025 (GLOBE NEWSWIRE) -- 22nd Century Group, Inc. (Nasdaq: XXII), the only tobacco products company that is leading the fight against nicotine by offering smokers a choice about their nicotine consumption, today announced the advancement of a 100mm VLN® reduced nicotine content cigarett ...
Achieve Life Sciences to Present at the Jefferies Global Healthcare Conference
Globenewswire· 2025-05-28 12:30
Company Overview - Achieve Life Sciences, Inc. is a late-stage specialty pharmaceutical company focused on the global development and commercialization of cytisinicline as a treatment for nicotine dependence and smoking cessation [3] - The company has successfully completed two Phase 3 studies and one Phase 2 study related to cytisinicline for smoking and vaping cessation [3] - Achieve plans to submit its new drug application for smoking cessation in June 2025 and has conducted a successful end-of-Phase 2 meeting with the FDA for a future vaping indication [3] Product Information - Cytisinicline is a plant-based alkaloid that interacts with nicotinic acetylcholine receptors in the brain, helping to reduce nicotine cravings and the satisfaction associated with nicotine products [6] - Approximately 29 million adults in the U.S. smoke combustible cigarettes, and tobacco use is the leading cause of preventable death, responsible for over eight million deaths worldwide annually [4] - There are over 11 million adults in the U.S. who use e-cigarettes, with no FDA-approved treatments specifically for nicotine e-cigarette cessation, highlighting a critical need that cytisinicline aims to address [5] Upcoming Events - Rick Stewart, CEO of Achieve, will present at the Jefferies Global Healthcare Conference on June 4, 2025, at 5:30 PM EDT, with a live webcast available on the company's Investor Relations website [2]
Achieve Life Sciences to Present New Data at the 2025 ATS International Conference Demonstrating that Cytisinicline Reduced Cravings and Nicotine Intake
Globenewswire· 2025-05-20 12:30
Core Insights - Achieve Life Sciences is presenting additional analyses from its Phase 3 ORCA-3 study on cytisinicline at the 2025 ATS International Conference, emphasizing its dual mechanism of action in treating nicotine dependence [1][8] - Cytisinicline has shown significant efficacy in reducing nicotine cravings and intake, even among smokers who do not completely quit, indicating its potential as a therapeutic option for smoking cessation [3][4] Company Overview - Achieve Life Sciences is a late-stage specialty pharmaceutical company focused on developing cytisinicline for nicotine dependence and smoking cessation, having completed two Phase 3 studies and one Phase 2 study for vaping cessation [7] - The company plans to submit a New Drug Application for cytisinicline in June 2025, aiming to address the smoking health epidemic affecting millions [6][7] Clinical Findings - The ORCA-3 study demonstrated a significant reduction in craving scores (p=0.0001) and serum cotinine levels among participants treated with cytisinicline compared to placebo, with a reduction equivalent to nearly four times more in cotinine levels [4][5] - Cytisinicline's dual action as a selective partial agonist and antagonist at the nicotinic acetylcholine receptor may help smokers reduce their nicotine intake while on the path to quitting [3][5] Market Context - There are approximately 29 million adult smokers in the U.S., with smoking being the leading cause of preventable death, highlighting the critical need for effective cessation treatments [9] - Cytisinicline has received Breakthrough Therapy designation from the FDA, indicating its potential to address the urgent need for effective nicotine cessation therapies [10][11]