Achieve Life Sciences Inc
NASDAQ:ACHV
Achieve Life Sciences Inc
Achieve Life Sciences, Inc. is a clinical-stage pharmaceutical company, which engages in the development and commercialization of cytisinicline for smoking cessation. The company is headquartered in Seattle, Washington and currently employs 16 full-time employees. The firm is engaged in development and commercialization of cytisinicline for smoking cessation and nicotine addiction. The Company’s product candidate, cytisinicline, is a naturally occurring plant-based alkaloid from the seeds of the Laburnum anagyroides plant. Cytisinicline is structurally similar to nicotine and a mechanism of action that is both agonistic and antagonistic. The firm is aid in smoking cessation, or nicotine addiction, by interacting with nicotine receptors in the brain by reducing the severity of nicotine withdrawal symptoms through agonistic effects on nicotine receptors and by reducing the reward and satisfaction associated with nicotine through antagonistic properties. The Company’s has two prescription oral treatments for smoking cessation are available in the United States: Chantix (varenicline) and Zyban (bupropion).
Achieve Life Sciences, Inc. is a clinical-stage pharmaceutical company, which engages in the development and commercialization of cytisinicline for smoking cessation. The company is headquartered in Seattle, Washington and currently employs 16 full-time employees. The firm is engaged in development and commercialization of cytisinicline for smoking cessation and nicotine addiction. The Company’s product candidate, cytisinicline, is a naturally occurring plant-based alkaloid from the seeds of the Laburnum anagyroides plant. Cytisinicline is structurally similar to nicotine and a mechanism of action that is both agonistic and antagonistic. The firm is aid in smoking cessation, or nicotine addiction, by interacting with nicotine receptors in the brain by reducing the severity of nicotine withdrawal symptoms through agonistic effects on nicotine receptors and by reducing the reward and satisfaction associated with nicotine through antagonistic properties. The Company’s has two prescription oral treatments for smoking cessation are available in the United States: Chantix (varenicline) and Zyban (bupropion).
FDA Progress: Achieve's NDA for cytisinicline as a smoking cessation treatment has been accepted by the FDA, with a PDUFA action date set for June 20, 2026.
Priority Voucher Win: The company received an FDA Commissioner's National Priority Voucher for the vaping indication, allowing for an expedited 1-2 month NDA review versus the standard 10-12 months.
Clinical Data: Long-term safety data from the ORCA-OL trial showed cytisinicline is well-tolerated, with mostly mild adverse events and high participant retention.
COPD Subgroup Success: Cytisinicline showed significant quit rates among smokers with COPD, a group typically hard to treat.
Commercial Readiness: The company is preparing for launch in 2026 with advanced AI-driven commercialization strategies, supply chain buildout, and foundational licensing and distribution in place.
Cash Position: Cash and equivalents were $48.1 million as of September 30, 2025, with runway expected into the second half of 2026. Additional funding will be needed for the vaping study.
Complementary Distribution: Both specialty and retail strategies will be pursued to distribute cytisinicline.
