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Achieve Life Sciences Announces Granting of New Hire Inducement Awards
Globenewswire· 2025-10-02 20:01
SEATTLE and VANCOUVER, British Columbia, Oct. 02, 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 treatment of nicotine dependence for smoking cessation, today announced that effective October 1, 2025, Achieve’s board of directors approved stock option grants to purchase an aggregate of 161,000 shares of its common stock for five new employees under Achieve’s 2024 E ...
Achieve Life Sciences Announces Publication in Thorax of Data Demonstrating Cytisinicline's Potential Efficacy and Tolerability for Smoking Cessation in Individuals with COPD
Globenewswire· 2025-09-22 12:30
SEATTLE and VANCOUVER, British Columbia, Sept. 22, 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 treatment of nicotine dependence, today announced the publication of new data in Thorax demonstrating that cytisinicline significantly improved smoking quit rates compared to placebo in adults with and without chronic obstructive pulmonary disease (COPD). The Thorax pub ...
Achieve Life Sciences Promotes Craig Donnelly to Chief Operations Officer
Globenewswire· 2025-09-18 12:30
Donnelly brings more than 25 years of biopharmaceutical expertise in CMC and regulatory operationsSEATTLE and VANCOUVER, British Columbia, Sept. 18, 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 treatment of nicotine dependence for smoking cessation, today announced the promotion of Craig Donnelly to Chief Operations Officer. Mr. Donnelly has been with Achieve sin ...
Achieve Life Sciences Names Dr. Mark Rubinstein Interim Chief Medical Officer
Globenewswire· 2025-09-11 21:01
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]
Achieve Life Sciences(ACHV) - 2025 Q2 - Earnings Call Transcript
2025-08-07 13:30
Financial Data and Key Metrics Changes - Achieve Life Sciences closed the second quarter with a strengthened balance sheet following a successful $45 million public offering in June, which included common stock and warrants [29] - As of June 30, 2025, the company had cash, cash equivalents, and marketable securities totaling $55.4 million, expected to support operations into 2026 [29] - Total operating expenses for the three and six months ended June 30, 2025, were $12.6 million and $25.5 million respectively, consistent with expectations as the company increased investment in regulatory and pre-commercial planning [30] - The net loss for the same periods was $12.7 million and $25.5 million respectively [30] Business Line Data and Key Metrics Changes - The company achieved three transformative milestones: the submission of a new drug application (NDA) for cytisinicline, a strategic partnership with Omnicom, and a capital raise of $49 million [5][6] - The NDA submission is supported by data from over 2,000 clinical trial participants, including results from two Phase III studies and long-term safety data [12][13] Market Data and Key Metrics Changes - There are approximately 29 million smokers in the U.S., with over 15 million attempting to quit each year, highlighting a significant market opportunity for cytisinicline [7] - The annual cost of smoking-related health issues in the U.S. is over $600 billion, indicating a substantial public health burden [8] Company Strategy and Development Direction - The company aims to change the narrative around nicotine dependence, positioning it as a medical condition that requires effective treatment options [7][24] - Achieve is focused on a data-driven approach to its commercial launch strategy, leveraging a proprietary AI-enabled platform for decision-making and performance optimization [19][26] - The strategic partnership with Omnicom is intended to enhance brand development, market access, and stakeholder engagement ahead of the product launch [18][27] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the regulatory process and anticipates receiving the FDA's Day 74 NDA acceptance letter in mid-September [31] - The company is committed to executing its strategy with financial prudence while preparing for a potential product launch in late 2026 [31][32] - Management highlighted the importance of building relationships with payers to ensure rapid access to cytisinicline following approval [22][23] Other Important Information - The company plans to complete the ORCA-OL study database by the end of the year and aims to present the results in 2026 [15][68] - Achieve is actively engaging with the FDA and has requested a priority review for the NDA submission, although a standard review is currently anticipated [50] Q&A Session Summary Question: Will the 120-day safety update include only 100 patients or the full 290? - The company will submit all subjects available at the time of the database cut, which will be more than 100 but not the full 290 [34] Question: How will commercial spending ramp up ahead of launch? - The company will incrementally increase pre-commercial activities prior to approval, with a disciplined approach to commercial investment [35][36] Question: Will cytisinicline be priced at a premium compared to generic options? - The company views cytisinicline as a branded product at a premium price, supported by its differentiated profile [37] Question: What initial contact methods will be used to reach providers? - The company plans to identify individual needs of targeted physicians and engage through various channels, including social media and email [40][42] Question: What is the overall safety profile of cytisinicline? - The safety profile remains consistent with previous data, with no new safety signals identified [46][47] Question: Will there be any updates on future clinical development before the end of the year? - The company plans to complete the ORCA-OL study database quickly and aims to present data at conferences in 2026 [66][68]
Achieve Life Sciences (ACHV) Earnings Call Presentation
2025-08-06 22:00
Market Opportunity and Unmet Needs - Achieve Life Sciences has a unique opportunity to address a market of up to 50 million Americans who use tobacco with Cytisinicline[6] - Nicotine dependence is a public health crisis costing billions of dollars[6] and there are ~29 million US smokers with few treatment options[12] - Approximately 60% of adult e-cigarette users want to quit[14], with ~17 million US adults reporting e-cigarette use[16] - An estimated $11 Billion Rx opportunity exists in the market[46] Cytisinicline's Potential and Clinical Data - Cytisinicline is presented as the first potential new nicotine dependence treatment option in nearly 20 years[6, 18] - ORCA-2 and ORCA-3 trials showed strong results in smoking cessation, demonstrating efficacy, tolerability, and craving reduction[22] - In the 12-week Cytisinicline Treatment, the quit rate is 32.6% compared to 7% in the placebo group[23] - In the 6-week Cytisinicline Treatment, the quit rate is 25.3% compared to 4.4% in the placebo group[23] - Phase 2 ORCA-V1 trial showed a 2.6x (p=0.035) increased likelihood of quitting vaping with cytisinicline[39] Commercialization Strategy - The company anticipates filing a Smoking cessation NDA with launch expected in 2H26[6] - A focused launch strategy will leverage innovative, data-driven solutions to drive adoption and future growth[7] - The company will focus on high-volume prescribers and engaged quitters[48] - The company will target the varenicline market share, which peaked at ~2.8M Rx (75% in U S market - $800M)[51]
Achieve Life Sciences Reports First Quarter 2025 Financial Results and Highlights Updates in Cytisinicline Program
Globenewswire· 2025-05-13 11:30
Core Viewpoint - Achieve Life Sciences plans to submit a New Drug Application (NDA) for cytisinicline to the FDA in June 2025, marking a significant milestone in the development of a new treatment for smoking cessation [1][2]. Company Developments - The company reported financial results for Q1 2025, with cash and equivalents totaling $23.2 million and a net loss of $12.8 million for the quarter [10][20]. - Achieve has successfully completed the FDA's long-term exposure requirements for cytisinicline, demonstrating safety data on over 300 participants completing six months and 100 participants completing one year of treatment [6][8]. - The company conducted a Science Advisory Board (SAB) meeting with leading experts to discuss clinical progress and NDA preparations [9]. Clinical Trial Results - The Phase 3 ORCA-3 trial results published in JAMA Internal Medicine confirmed cytisinicline's efficacy and tolerability, showing reduced nicotine cravings and extended quit rates through 24 weeks [5][8]. - In the ORCA-OL long-term exposure trial, 75% of the 479 enrolled participants remained on treatment, indicating the potential for cytisinicline to shift the treatment paradigm for smoking cessation [4][6]. Market Context - There are approximately 29 million adults in the U.S. who smoke combustible cigarettes, with tobacco use being the leading cause of preventable death [13]. - Cytisinicline has been granted Breakthrough Therapy designation by the FDA, addressing the critical need for effective treatments for nicotine dependence, including e-cigarette cessation [14][15].
Achieve Life Sciences Announces Cytisinicline Phase 3 ORCA-3 Trial Publication on Smoking Cessation in JAMA Internal Medicine
Newsfilter· 2025-04-21 15:19
Core Insights - Achieve Life Sciences announced significant results from the ORCA-3 trial, demonstrating that cytisinicline effectively aids in smoking cessation by increasing quitting rates and reducing nicotine cravings compared to placebo [1][2][4] Company Overview - Achieve Life Sciences is a late-stage specialty pharmaceutical company focused on developing cytisinicline for nicotine dependence and smoking cessation [7][8] - The company plans to submit a New Drug Application (NDA) for cytisinicline to the FDA in June 2025 [1][5] Clinical Trial Details - The ORCA-3 trial involved 792 U.S. adults, assessing the efficacy of cytisinicline over 6 and 12 weeks, with results published in JAMA Internal Medicine [1][6] - Participants had an average age of 53 years, smoked a median of 20 cigarettes per day, and had a median smoking history of 36 years [3][6] - Cytisinicline was administered at a dosage of 3mg three times daily, with behavioral support provided throughout the trial [6] Efficacy and Tolerability - Cytisinicline showed a significant increase in the odds of smoking cessation and a reduction in nicotine cravings, leading to decreased nicotine intake among participants [4][5] - The drug was well tolerated, attributed to its selective binding to nicotine receptors with limited off-target effects [2][4] Market Context - Tobacco use is the leading cause of preventable death, with over 8 million deaths globally and nearly half a million in the U.S. annually [9] - There is a critical need for effective smoking cessation treatments, as current options are limited [5][9]
Achieve Life Sciences to Present at the Barclays 27th Annual Global Healthcare Conference
Globenewswire· 2025-03-07 13:30
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 for smoking cessation and one Phase 2 study for vaping cessation, with plans to submit a new drug application in Q2 2025 [3][6] 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 associated with nicotine products [6] - Approximately 29 million adults smoke combustible cigarettes in the U.S., 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 [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 - Achieve Life Sciences will present at the Barclays 27th Annual Global Healthcare Conference from March 11-13, 2025, with CEO Rick Stewart scheduled to present on March 12, 2025 [1][2]