Core Viewpoint - Achieve Life Sciences has promoted Dr. Mark Rubinstein to Chief Medical Officer following his successful tenure as Interim CMO, during which the company achieved significant clinical and regulatory milestones in the development of cytisinicline for smoking cessation [1][2][3]. 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 [5]. - The company submitted a New Drug Application (NDA) to the FDA in June 2025, which has been accepted for review, with a Prescription Drug User Fee Act (PDUFA) date set for June 20, 2026 [5]. Clinical Development - Under Dr. Rubinstein's leadership, Achieve Life Sciences has co-authored a paper demonstrating the efficacy and tolerability of cytisinicline for smoking cessation in individuals with Chronic Obstructive Pulmonary Disease (COPD) [2]. - Cytisinicline has shown a robust safety profile in long-term trials, indicating its potential to address unmet medical needs related to nicotine dependence [4]. 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 8 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 [7]. Product Mechanism - 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 [8].

Core Insights - Achieve Life Sciences, Inc. has received FDA acceptance for its New Drug Application (NDA) for cytisinicline, targeting a Prescription Drug User Fee Act (PDUFA) action date of June 20, 2026, for smoking cessation treatment [2][5][13] - The FDA awarded cytisinicline the Commissioner's National Priority Voucher for vaping cessation, highlighting its potential as the first FDA-approved therapy for nicotine dependence related to vaping [2][7][15] - Recent post hoc data published in Thorax indicates that cytisinicline significantly improves smoking quit rates in adults with chronic obstructive pulmonary disease (COPD) [4][8] Company Developments - Achieve Life Sciences has made significant advancements in its cytisinicline development program, including the completion of key clinical trials and safety updates [4][9] - The company appointed Erik Atkisson as Chief Legal Officer, enhancing its leadership team as it prepares for regulatory review and potential commercialization [10] - Financial results as of September 30, 2025, show cash and cash equivalents of $48.1 million, with total operating expenses of $14.7 million for the third quarter [11][21] Market Context - Approximately 60% of the 17 million adult e-cigarette users in the U.S. express a desire to quit, indicating a significant unmet medical need for effective cessation therapies [2][15] - Cytisinicline is positioned as a potential first-in-class treatment for vaping cessation, addressing a growing public health concern [7][15] - The tobacco use landscape includes around 29 million adults in the U.S. who smoke combustible cigarettes, with tobacco being the leading cause of preventable death [14][15]

Core Insights - Achieve Life Sciences has made significant progress in the regulatory process for cytisinicline, a treatment for nicotine dependence, with the completion of the ORCA-OL long-term safety trial and submission of a 120-day safety update to the FDA [1][2][7] Company Developments - The ORCA-OL trial successfully concluded with 334 participants completing one year of treatment, surpassing FDA requirements for safety data [3][7] - The Data Safety Monitoring Committee (DSMC) conducted its final review and found no safety concerns related to cytisinicline, indicating a favorable safety profile [2][7] - The company submitted a New Drug Application (NDA) to the FDA in June 2025, which has been accepted for review, with a Prescription Drug User Fee Act (PDUFA) date set for June 20, 2026 [5] Industry Context - Approximately 29 million adults in the U.S. smoke combustible cigarettes, and tobacco use is the leading cause of preventable death, highlighting the critical need for effective smoking cessation treatments [6] - There are currently no FDA-approved treatments specifically for e-cigarette cessation, indicating a significant market opportunity for cytisinicline [8][9]

Core Insights - Achieve Life Sciences, Inc. is focused on the development and commercialization of cytisinicline as a treatment for nicotine dependence and smoking cessation [1][3] - The company will report its Q3 2025 financial results and provide updates on the cytisinicline program on November 6, 2025 [1] - The FDA has accepted Achieve's New Drug Application for cytisinicline, with a PDUFA date set for June 20, 2026 [3] Company Overview - Achieve Life Sciences is a late-stage specialty pharmaceutical company addressing the global smoking health crisis through cytisinicline [3] - Cytisinicline has shown efficacy in two completed Phase 3 studies and an open-label safety study for smoking cessation [3] - The company has also completed a Phase 2 study for vaping cessation and had a successful end-of-Phase 2 meeting with the FDA [3] Industry Context - Approximately 29 million adults in the U.S. smoke combustible cigarettes, with tobacco use being the leading cause of preventable death [4] - 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 [5] - The FDA has recognized the need for treatments in this area by awarding a National Priority Voucher and granting Breakthrough Therapy designation [5] Product Information - Cytisinicline is a plant-based alkaloid that interacts with nicotinic acetylcholine receptors to help treat nicotine addiction [6] - The product is still investigational and has not yet received FDA approval for any indication in the U.S. [6]

Core Insights - Achieve Life Sciences has appointed Erik Atkisson as Chief Legal Officer, bringing over 25 years of legal expertise in the biopharmaceutical sector to the company [1][2] Company Overview - Achieve Life Sciences is a late-stage specialty pharmaceutical company focused on developing and commercializing cytisinicline for nicotine dependence treatment [3] - The company submitted a New Drug Application (NDA) for cytisinicline to the FDA in June 2025, which has been accepted for review with a PDUFA date set for June 20, 2026 [3] Product Information - Cytisinicline is a plant-derived alkaloid that interacts with nicotinic acetylcholine receptors to help treat nicotine dependence for both smoking and vaping cessation [5][6] - The drug has been granted Breakthrough Therapy designation by the FDA, addressing a significant unmet need in nicotine e-cigarette cessation [4] Market Context - Approximately 29 million adults in the U.S. smoke combustible cigarettes, with tobacco use being the leading cause of preventable death globally [4] - There are around 17 million adults in the U.S. who use e-cigarettes, highlighting the growing need for effective cessation treatments [4]

Core Insights - Achieve Life Sciences has received a Commissioner's National Priority Voucher from the FDA for cytisinicline, aimed at treating nicotine dependence specifically for e-cigarette or vaping cessation, marking it as one of only nine therapies in the inaugural year of the program [1][4] - Cytisinicline is positioned as a first-in-class pharmacotherapy for a significant unmet medical need, with around 60% of the 17 million adult e-cigarette users in the U.S. wanting to quit [2][9] - The FDA has granted Breakthrough Therapy designation to cytisinicline, which demonstrated clinical efficacy in the Phase 2 ORCA-V1 trial, showing participants were 2.6 times more likely to quit using nicotine e-cigarettes compared to placebo [3][9] Company Overview - Achieve Life Sciences is a late-stage specialty pharmaceutical company focused on developing cytisinicline to address nicotine dependence and has submitted a New Drug Application (NDA) for smoking cessation, with a target action date of June 20, 2026 [5][6] - The company aims to pioneer the first FDA-approved treatment for vaping cessation, addressing a critical gap in treatment options for nicotine dependence [3][4] Market Context - There are approximately 29 million adults in the U.S. who smoke combustible cigarettes, and tobacco use is the leading cause of preventable death, responsible for over 8 million deaths globally [7][8] - The vaping market is also significant, with around 17 million adults in the U.S. using e-cigarettes, and no FDA-approved treatments currently available for vaping cessation [9][10]

Core Insights - Achieve Life Sciences, Inc. has approved stock option grants for five new employees as part of its 2024 Equity Inducement Plan, totaling 161,000 shares of common stock [1][2][3] Company Overview - Achieve Life Sciences is a late-stage specialty pharmaceutical company focused on developing and commercializing cytisinicline for nicotine dependence treatment [4] - The company submitted a New Drug Application (NDA) to the FDA in June 2025, which has been accepted for review, with a PDUFA date set for June 20, 2026 [4] - Cytisinicline is being developed for smoking cessation in adults, supported by two completed Phase 3 studies and an open-label safety study [4] Industry Context - Approximately 29 million adults in the U.S. smoke combustible cigarettes, with tobacco use being the leading cause of preventable death globally [5] - There are around 17 million adults in the U.S. who use e-cigarettes, highlighting a significant market for cessation products [5] - Cytisinicline has received Breakthrough Therapy designation from the FDA to address the unmet need for e-cigarette cessation treatments [5][6]

Core Insights - Achieve Life Sciences announced new data showing that cytisinicline significantly improves smoking quit rates in adults with and without chronic obstructive pulmonary disease (COPD) compared to placebo [1][2][3] Company Overview - Achieve Life Sciences is a late-stage specialty pharmaceutical company focused on developing and commercializing cytisinicline for nicotine dependence treatment [6] - The FDA has accepted Achieve's New Drug Application for cytisinicline, with a target action date of June 20, 2026 [5][6] Clinical Data - The publication in Thorax presents a post hoc analysis of over 1,600 participants from the ORCA-2 and ORCA-3 trials, highlighting the efficacy and safety of cytisinicline in individuals with self-reported COPD [2][3] - Cytisinicline demonstrated statistically significant increases in continuous smoking abstinence for both COPD and non-COPD subgroups, with quit rates for COPD participants comparable to those without COPD [3] Health Impact - Nearly 16 million U.S. adults have been diagnosed with COPD, with 6 million currently smoking; quitting smoking is crucial for improving health outcomes in this population [4] - Approximately 80% of COPD deaths are attributed to smoking, emphasizing the need for effective cessation tools like cytisinicline [4] Future Developments - Achieve has completed a Phase 2 trial for cytisinicline in vaping cessation and has received Breakthrough Therapy designation from the FDA for this indication [5][8]

Core Insights - Achieve Life Sciences, Inc. has appointed Mark Rubinstein, M.D. as Interim Chief Medical Officer, succeeding Cindy Jacobs, Ph.D., M.D. [1][3] - The company is focused on the development and commercialization of cytisinicline for nicotine dependence treatment, with recent FDA acceptance of its New Drug Application [3][4] - Cytisinicline is positioned as a potential treatment for the estimated 15 million American adults who attempt to quit smoking each year [3] Company Overview - Achieve Life Sciences is a late-stage specialty pharmaceutical company dedicated to addressing the global nicotine dependence epidemic through cytisinicline [4] - The FDA has set a PDUFA completion date of June 20, 2026, for the cytisinicline New Drug Application [4] - The company has completed a Phase 2 study for vaping cessation and had a successful end-of-Phase 2 meeting with the FDA for a future vaping indication [4] Industry Context - Approximately 29 million adults in the U.S. smoke combustible cigarettes, with tobacco use being the leading cause of preventable death globally [5] - There are around 17 million adults in the U.S. who use e-cigarettes, and no FDA-approved treatments currently exist specifically for nicotine e-cigarette cessation [5] - Cytisinicline has received Breakthrough Therapy designation from the FDA to address the unmet need in nicotine dependence treatment [5][6]

Core Insights - Achieve Life Sciences has received FDA acceptance for its New Drug Application (NDA) for cytisinicline, marking a significant step towards potentially the first new FDA-approved pharmacotherapy for smoking cessation in two decades, with a PDUFA target date set for June 20, 2026 [2][4]. Company Overview - Achieve Life Sciences is a late-stage specialty pharmaceutical company focused on developing and commercializing cytisinicline to address nicotine dependence and smoking cessation [5]. - The company has conducted extensive research, with over 2,000 clinical trial participants contributing to the evidence supporting cytisinicline's efficacy [3]. Clinical Trials and Efficacy - The ORCA-2 and ORCA-3 Phase 3 clinical trials demonstrated that cytisinicline, administered for either 6 or 12 weeks alongside standard behavioral support, resulted in significantly higher smoking abstinence rates compared to placebo [3]. - Safety data from the trials included over 400 participants with at least six months of cumulative exposure to cytisinicline, showing no new safety concerns [3]. Public Health Impact - Smoking is the leading cause of preventable death in the U.S., claiming nearly half a million lives annually and costing the economy over $600 billion each year [4][6]. - Approximately 15 million Americans attempt to quit smoking each year, highlighting the need for effective cessation tools [4]. Market Opportunity - There are about 29 million adults in the U.S. who smoke combustible cigarettes, and the company aims to provide a new treatment option for this population [6]. - Additionally, there are around 17 million adults using e-cigarettes, with no FDA-approved treatments currently available for nicotine e-cigarette cessation, indicating a significant unmet need [7]. Product Mechanism - Cytisinicline is a plant-derived alkaloid that interacts with nicotinic acetylcholine receptors in the brain, helping to reduce nicotine cravings and the satisfaction associated with nicotine products [8].