StockNews.AI
ACHV
StockNews.AI
8 hrs

Achieve Life Sciences Announces Granting of New Hire Inducement Awards

1. Achieve grants stock options for 161,000 shares to five new employees. 2. FDA accepted NDA for cytisinicline; PDUFA date is June 20, 2026. 3. Cytisinicline aims to treat nicotine dependence among smokers and vapers. 4. Company completed Phase 2 study for vaping cessation; FDA acknowledges unmet need. 5. Tobacco use causes significant health issues; cytisinicline targets this crisis.

7m saved
Insight
Article

FAQ

Why Bullish?

FDA acceptance of NDA could lead to increased market interest, similar to other drug approvals.

How important is it?

The new employee stock options and NDA acceptance signify growth and potential market validation.

Why Long Term?

FDA deadlines often influence stock behavior; developments until June 2026 may affect valuation.

Related Companies

NDAQVRTXRXDX
October 02, 2025 16:01 ET  | Source: Achieve Life Sciences 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 Equity Inducement Plan. The stock options have an exercise price equal to the closing price of Achieve’s common stock on October 1, 2025. Each stock option has a ten-year term and will vest as to 25% of the shares underlying the stock option on the first anniversary following commencement of employment, and the remaining 75% of the shares underlying the stock option will vest in 36 equal monthly installments thereafter, subject to the employee’s continued service through each applicable vesting date. The stock options are subject to the terms and conditions of the 2024 Equity Inducement Plan, as well as the terms and conditions of the stock option agreement covering the grant and were made as an inducement material to the individual entering into employment with Achieve in accordance with Nasdaq Listing Rule 5635(c)(4). 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. In September 2025, the company announced that its New Drug Application, submitted to the U.S. Food and Drug Administration (FDA) in June 2025, had been accepted for review. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) date of June 20, 2026. The NDA is for cytisinicline to be used as a treatment of nicotine dependence for smoking cessation in adults, based on two successfully completed Phase 3 studies and its open-label safety study. Additionally, the company has completed a Phase 2 study with cytisinicline in vaping cessation and conducted a successful end-of-Phase 2 meeting with the FDA for a future vaping indication. About CytisiniclineThere are approximately 29 million adults in the United States 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 approximately 17 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 by the FDA to address this critical unmet need. Cytisinicline is a plant-derived alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. It is believed to aid in treating nicotine dependence for smoking cessation 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 a new investigational product candidate being developed for the treatment of nicotine dependence for smoking cessation and has not been approved by the Food and Drug Administration for any indication in the United States. Achieve ContactNicole JonesVice President, Strategic Communications and Stakeholder Relationsir@achievelifesciences.com425-686-1510 References1VanFrank B, Malarcher A, Cornelius ME, Schecter A, Jamal A, Tynan M. Adult Smoking Cessation — United States, 2022. MMWR Morb Mortal Wkly Rep 2024;73:633–641.2World Health Organization. WHO Report on the Global Tobacco Epidemic, 2019. Geneva: World Health Organization, 2017.3U.S. Department of Health and Human Services. The Health Consequences of Smoking – 50 Years of Progress. A Report of the Surgeon General, 2014.4Vahratian A, Briones EM, Jamal A, Marynak KL. Electronic cigarette use among adults in the United States, 2019–2023. NCHS Data Brief, no 524. Hyattsville, MD: National Center for Health Statistics. 2025. DOI: https://dx.doi.org/ 10.15620/cdc/174583.5Jamal 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.

Related News