Achieve Life Sciences to Present at the Oppenheimer Healthcare Life Sciences Conference
MWN-AI** Summary
Achieve Life Sciences, Inc. (Nasdaq: ACHV) is set to present at the virtual Oppenheimer 35th Annual Healthcare Life Sciences Conference on February 11, 2025, at 10:00 a.m. EST. Rick Stewart, the company’s CEO, will provide insights into Achieve's ongoing initiatives, particularly its focus on cytisinicline—a plant-based alkaloid aimed at addressing smoking cessation and nicotine dependence.
As a late-stage specialty pharmaceutical company, Achieve has made significant progress in the development of cytisinicline. The company has successfully concluded two Phase 3 clinical trials for smoking cessation and one Phase 2 study targeting vaping cessation. Looking ahead, Achieve plans to submit a New Drug Application (NDA) for cytisinicline for smoking cessation by the second quarter of 2025, having also completed an open-label safety study.
Cytisinicline is designed to interact with nicotinic acetylcholine receptors in the brain, mitigating the cravings and rewards associated with nicotine use, thus aiding in the cessation of both smoking and vaping. Despite the growing population of individuals affected by tobacco and nicotine use—approximately 29 million adults in the U.S. smoke cigarettes, and over 11 million use e-cigarettes—there are currently no FDA-approved treatments targeted specifically at nicotine e-cigarette cessation, highlighting a critical market need.
Achieve Life Sciences has received Breakthrough Therapy designation from the FDA for cytisinicline, underscoring its potential to fulfill this urgent healthcare requirement. However, the company faces typical risks associated with drug development, including regulatory approvals and market commercialization.
Investors can find additional details on Achieve's initiatives via the company’s Investor Relations website or through direct contact with their investor relations team.
MWN-AI** Analysis
As Achieve Life Sciences prepares to present at the Oppenheimer Healthcare Life Sciences Conference, investors should carefully consider the implications of their advancements in smoking and vaping cessation treatments, particularly the potential of cytisinicline. With the company expecting to submit a New Drug Application (NDA) in Q2 2025 following promising Phase 3 results, there is noticeable optimism surrounding the stock.
Cytisinicline's Breakthrough Therapy designation marks a critical endorsement by the FDA, positioning the compound as a promising alternative in a market sorely lacking FDA-approved smoking cessation aids, especially for e-cigarettes. Given the substantial evidence pointing to tobacco use as the leading cause of preventable death, the opportunity for an effective cessation tool is significant. With approximately 29 million smokers and over 11 million e-cigarette users in the U.S., the market potential for cytisinicline is extensive.
However, potential investors should be mindful of the inherent risks. Achieve's plans hinge on regulatory approval and successful commercialization, which are uncertain and subject to extensive clinical validation. Additionally, market conditions, such as inflation and geopolitical risks, may impact investor sentiment and funding capabilities. Prior to investing, stakeholders should scrutinize Achieve’s upcoming clinical trial results and market performance, along with broader industry trends that may alter the competitive landscape.
In conclusion, while Achieve Life Sciences holds substantial promise with its cytisinicline product, a cautious approach is advisable. Investors should weigh the potential rewards against the uncertainties of drug approval processes and market competition. Keeping abreast of developments during and following the Oppenheimer conference will be pivotal in making informed investment decisions in this nascent pharmaceutical segment.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
SEATTLE and VANCOUVER, British Columbia, Feb. 11, 2025 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage specialty pharmaceutical company focused on the global development and commercialization of cytisinicline for smoking cessation and nicotine dependence, today announced that Rick Stewart, Chief Executive Officer of Achieve, will be presenting today at the virtual Oppenheimer 35th Annual Healthcare Life Sciences Conference on Tuesday, February 11, 2025, at 10:00 a.m. EST.
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 clinical developments of Achieve Life Sciences Inc. (ACHV) in cytisinicline for smoking cessation impact the healthcare landscape in Seattle and Vancouver, considering their urban smoking rates?
In what ways could the FDA's upcoming decision on Achieve Life Sciences Inc. (ACHV)'s cytisinicline influence smoking cessation programs in Seattle and Vancouver, given local public health initiatives?
How does the presence of Achieve Life Sciences Inc. (ACHV) in the Pacific Northwest, particularly Seattle and Vancouver, create opportunities for collaboration in addressing nicotine dependence?
What role do Seattle and Vancouver's health policies play in supporting innovations from companies like Achieve Life Sciences Inc. (ACHV) aimed at reducing smoking-related health issues?
**MWN-AI FAQ is based on asking OpenAI questions about Achieve Life Sciences Inc. (NASDAQ: ACHV).
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