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Achieve Life Sciences

Achieve Life Sciences

ACHV
Bothell, Canada· Est. 1998

Achieve Life Sciences is a publicly traded, late-stage biopharmaceutical company focused on developing and commercializing cytisinicline, a novel treatment for nicotine dependence. The company's New Drug Application (NDA) for smoking cessation was accepted by the FDA in September 2025, with a key decision date set for June 2026. With a dual headquarters in Bothell, Washington, and Vancouver, British Columbia, Achieve is targeting a massive market opportunity driven by the significant unmet medical need and the staggering healthcare costs associated with smoking.

achievelifesciences.com

ACHV · Stock Price

USD 2.900.02 (-0.68%)
Market Cap: $153.8M

Historical price data

AI Company Overview

Achieve Life Sciences is a publicly traded, late-stage biopharmaceutical company focused on developing and commercializing cytisinicline, a novel treatment for nicotine dependence. The company's New Drug Application (NDA) for smoking cessation was accepted by the FDA in September 2025, with a key decision date set for June 2026. With a dual headquarters in Bothell, Washington, and Vancouver, British Columbia, Achieve is targeting a massive market opportunity driven by the significant unmet medical need and the staggering healthcare costs associated with smoking.

Nicotine DependenceSmoking CessationSubstance Use Disorder

Technology Platform

Focused development of cytisinicline, a plant-based alkaloid that acts as a partial agonist on nicotinic acetylcholine receptors (nAChR) to alleviate withdrawal symptoms and competitively antagonizes nicotine binding to reduce smoking satisfaction, with a potentially improved tolerability profile.

Pipeline

37
37 drugs in pipeline9 in Phase 3
DrugIndicationStageWatch
Custirsen + Docetaxel + Prednisone + DexamethasoneProstate CancerPhase 3
Custirsen + DocetaxelNon-Small Cell Lung CancerPhase 3
Cytisinicline + PlaceboVaping CessationPhase 3
Taxol + TOCOSOL PaclitaxelBreast NeoplasmPhase 3
Cytisinicline + PlaceboSmoking CessationPhase 3

Funding History

2
Total raised:$40M
PIPE$25MJun 15, 2020
Series A$15MJun 15, 2017

Opportunities

The primary opportunity is the potential FDA approval and commercialization of cytisinicline for smoking cessation, targeting 29 million US smokers.
A successful launch could be followed by expansion into the vaping cessation market (17 million US users) and ex-US regulatory filings, addressing a global epidemic with a first-in-decades novel therapy.

Risk Factors

Key risks include regulatory rejection or delay by the FDA, challenges in commercializing the drug without an established sales force, potential difficulty displacing entrenched competitors like varenicline, and the company's pre-revenue financial status requiring further capital raises which could be dilutive.

Competitive Landscape

Main competitors are varenicline (Chantix), bupropion (Zyban), and nicotine replacement therapies (NRT). Cytisinicline aims to differentiate itself by offering comparable high efficacy to varenicline but with a potentially superior tolerability profile, specifically targeting reduced rates of nausea and neuropsychiatric side effects.