Achieve Life Sciences Inc
NASDAQ:ACHV
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Achieve Life Sciences Inc
NASDAQ:ACHV
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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).
NDA progress: Achieve submitted an NDA in June 2025 that has been accepted and is under FDA review; management says the PDUFA remains the "20th of June."
Launch timing: Company reiterates a planned commercial launch in the first half of 2027, contingent on product supply and operational readiness.
Vaping priority: Cytisinicline received the FDA Commissioner's National Priority Voucher for a vaping-cessation indication, giving an expedited review window (described as 1–2 months vs. typical 10–12 months) and prompting work on an ORCA V2 Phase III vaping trial.
Clinical/safety data: Long-term ORCA OL data (up to 52 weeks) showed strong tolerability, high patient satisfaction and >75% adherence in the long trial; pooled Phase III analyses (~1,600 participants) showed consistent efficacy across subgroups.
Manufacturing & supply: Company selected Adea Pharma Solutions for U.S. production to secure supply; the manufacturer named in the NDA had an FDA GMP inspection with two observations that are being addressed; Achieve says it has more than three years' supply of starting material.
Commercial prep: Building an AI-powered, omnichannel commercial platform, specialty pharmacy and 3PL arrangements; willpower awareness campaign launched to reframe nicotine dependence as a medical condition.
Finances: Cash and marketable securities totaled $36.4 million as of December 31, 2025; operating expenses and net loss reflect continued investment in regulatory, clinical and pre-commercial work.
