Achieve Life Sciences to Present at the Barclays 27th Annual Global Healthcare Conference
MWN-AI** Summary
Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage specialty pharmaceutical company focusing on the development of cytisinicline for treating nicotine dependence, is set to present at the Barclays 27th Annual Global Healthcare Conference from March 11-13, 2025, in Miami, FL. Rick Stewart, the company's CEO, will deliver a presentation on March 12 at 11:30 AM EDT, which can also be accessed through a live webcast on Achieve's investor relations website.
Achieve is dedicated to combating the global smoking and nicotine dependence epidemic through cytisinicline, which has shown promise in two completed Phase 3 studies for smoking cessation and a Phase 2 study targeting vaping cessation. The ongoing open-label safety study for cytisinicline has been fully enrolled, with plans to submit a New Drug Application to the FDA in Q2 2025. Moreover, Achieve has successfully concluded an end-of-Phase 2 meeting with the FDA regarding a future indication for vaping cessation, demonstrating the potential of cytisinicline to address urgent public health needs.
Cytisinicline is a plant-derived alkaloid that binds to nicotine receptors in the brain, helping to alleviate nicotine cravings and the satisfaction associated with nicotine products. This investigational drug is crucial given that tobacco use is the leading cause of preventable death globally, accounting for over eight million deaths annually. With more than 29 million adults smoking combustible cigarettes and the prevalence of e-cigarette use among U.S. middle and high school students continuing to rise, the need for effective cessation aids is critical. Cytisinicline has received Breakthrough Therapy designation from the FDA, signifying its potential as a vital treatment option for nicotine addiction.
As the company navigates clinical trials and market entry, Achieve Life Sciences remains committed to mitigating the health risks associated with nicotine dependence while advancing towards regulatory approval for its innovative treatment.
MWN-AI** Analysis
Achieve Life Sciences (Nasdaq: ACHV) is poised to elevate its visibility and attract investor interest with its upcoming presentation at the Barclays 27th Annual Global Healthcare Conference on March 12, 2025. As a late-stage pharmaceutical company focused on cytisinicline for nicotine dependence, the significance of this conference cannot be overstated, particularly against the backdrop of rising smoking rates and vaping concerns.
Cytisinicline, a plant-based alkaloid, has shown promise in reducing nicotine cravings and withdrawal symptoms in both traditional smoking and vapor product use scenarios. With approximately 29 million adults smoking in the U.S. and millions more using e-cigarettes, there exists a substantial market opportunity for successful interventions in nicotine addiction. Achieve has successfully completed Phase 3 studies and plans to submit its New Drug Application (NDA) in Q2 2025, positioning itself as a likely frontrunner in the development of FDA-approved treatments for e-cigarette cessation.
Investors should monitor key indicators leading up to the conference, including market sentiment and any news pertaining to regulatory developments or clinical trial outcomes. The Breakthrough Therapy designation granted to cytisinicline signals a robust endorsement from the FDA, suggesting that if approved, Achieve could capture a significant share of the burgeoning cessation market.
However, caution is warranted. Challenges remain, including the necessity for ongoing financing, potential delays in FDA review, and competitive pressures from alternative cessation methods. The macroeconomic environment also presents risks that could impact Achieve's operational capabilities.
With its ambitious goals and solid progress on its clinical pathway, Achieve Life Sciences presents a compelling investment opportunity. Investors should approach with a balanced view, weighing the significant upside potential against the inherent risks of biotechnology investments.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
SEATTLE and VANCOUVER, British Columbia, March 07, 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 that the company will be presenting at the Barclays 27th Annual Global Healthcare Conference to be held March 11-13, 2025, in Miami, FL.
Rick Stewart, Chief Executive Officer of Achieve, will present on Wednesday, March 12, 2025, at 11:30 AM EDT. A live webcast and replay of the presentation will be available on the Investor section of the company’s website. For more information, please contact your banking representative directly or visit the Achieve Life Sciences Investor Relations website .
About Achieve Life Sciences, Inc.
Achieve Life Sciences is a late-stage specialty pharmaceutical company committed to addressing the global smoking health and nicotine dependence epidemic through the development and commercialization of cytisinicline. The company has successfully completed two Phase 3 studies with cytisinicline for smoking cessation and one Phase 2 study with cytisinicline in vaping cessation. The company has fully enrolled its ongoing open-label safety study with cytisinicline and plans to submit its new drug application for smoking cessation in Q2 2025. Achieve has also conducted a successful end-of-Phase 2 meeting with the FDA for a future vaping indication.
About Cytisinicline
There are approximately 29 million adults who smoke combustible cigarettes. 1 Tobacco use is currently the leading cause of preventable death that is responsible for more than eight million deaths worldwide and nearly half a million deaths in the United States annually. 2,3 More than 87% of lung cancer deaths, 61% of all pulmonary disease deaths, and 32% of all deaths from coronary heart disease are attributable to smoking and exposure to secondhand smoke. 3
In addition, there are over 11 million adults in the United States who use e-cigarettes, also known as vaping. 4 In 2024, approximately 1.6 million middle and high school students in the United States reported using e-cigarettes. 5 There are no FDA-approved treatments indicated specifically as an aid to nicotine e-cigarette cessation. Cytisinicline has been granted Breakthrough Therapy designation to address this critical need.
Cytisinicline is a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. It is believed to aid in treating nicotine addiction for smoking and e-cigarette cessation by interacting with nicotine receptors in the brain, reducing the severity of nicotine craving symptoms, and reducing the reward and satisfaction associated with nicotine products. Cytisinicline is an investigational product candidate being developed for the treatment of nicotine addiction and has not been approved by the Food and Drug Administration for any indication in the United States.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the timing and nature of cytisinicline clinical development and regulatory review and approval, data results and commercialization activities, the potential market size for cytisinicline, the potential benefits, efficacy, safety and tolerability of cytisinicline, the development and effectiveness of new treatments, and the successful commercialization of cytisinicline. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Achieve may not actually achieve its plans or product development goals in a timely manner, if at all, or otherwise carry out its intentions or meet its expectations or projections disclosed in these forward-looking statements. These statements are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements, including, among others, the risk that cytisinicline may not demonstrate the hypothesized or expected benefits; the risk that Achieve may not be able to obtain additional financing to fund the development and commercialization of cytisinicline; the risk that cytisinicline will not receive regulatory approval or be successfully commercialized; the risk that new developments in the smoking and vaping cessation landscapes require changes in business strategy or clinical development plans; the risk that Achieve’s intellectual property may not be adequately protected; general business and economic conditions; risks related to the impact on our business of macroeconomic and geopolitical conditions, including inflation, volatile interest rates, volatility in the debt and equity markets, actual or perceived instability in the global banking system, global health crises and pandemics and geopolitical conflict and the other factors described in the risk factors set forth in Achieve’s filings with the Securities and Exchange Commission from time to time, including Achieve’s Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q. Achieve undertakes no obligation to update the forward-looking statements contained herein or to reflect events or circumstances occurring after the date hereof, other than as may be required by applicable.
Achieve Contact
Nicole Jones
ir@achievelifesciences.com
425-686-1510
References
1 VanFrank B, Malarcher A, Cornelius ME, Schecter A, Jamal A, Tynan M. Adult Smoking Cessation — United States, 2022. MMWR Morb Mortal Wkly Rep 2024;73:633–641.
2 World Health Organization. WHO Report on the Global Tobacco Epidemic, 2019. Geneva: World Health Organization, 2017.
3 U.S. Department of Health and Human Services. The Health Consequences of Smoking – 50 Years of Progress. A Report of the Surgeon General, 2014.
4 Cornelius ME, Loretan CG, Jamal A, et al. Tobacco Product Use Among Adults – United States, 2021. MMWR Morb Mortal Wkly Rep 2023;72:475–483.
5 Jamal A, Park-Lee E, Birdsey J, et al. Tobacco Product Use Among Middle and High School Students — National Youth Tobacco Survey, United States, 2024. MMWR Morb Mortal Wkly Rep 2024;73:917–924.
FAQ**
How might the developments from Achieve Life Sciences Inc. (Nasdaq: ACHV) impact the smoking cessation landscape in Seattle and Vancouver, especially considering the current prevalence of nicotine dependence?
What collaborations or partnerships could Achieve Life Sciences Inc. (ACHV) explore in Seattle and Vancouver to enhance the outreach and effectiveness of cytisinicline for smokers?
Given the health statistics surrounding smoking, how could Achieve Life Sciences Inc. (ACHV) drive public health initiatives in Seattle and Vancouver to promote tobacco cessation using cytisinicline?
How do regulatory environments in Seattle and Vancouver compare, and what implications might they have for Achieve Life Sciences Inc. (ACHV) in obtaining approval for cytisinicline?
**MWN-AI FAQ is based on asking OpenAI questions about Achieve Life Sciences Inc. (NASDAQ: ACHV).
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