Achieve Life Sciences, Inc. (ACHV) Stock

Achieve Life Sciences, Inc. (ACHV) is a Healthcare stock trading at $8.49 (as of 2026-09-02), with a market capitalization of $871.58M. Figures are sourced from first-party U.S. SEC EDGAR filings and market data.

Achieve Life Sciences, Inc., a clinical-stage pharmaceutical company, develops and commercializes of cytisinicline for smoking cessation and nicotine addiction in Canada, the United States, and the United Kingdom. The company offers cytisinicline, a plant-based alkaloid that interacts with nicotine receptors in the brain that reduce the severity of nicotine withdrawal symptoms. It has license agreements with Sopharma AD and University of Bristol. The company is based in Vancouver, Canada.

Understand Achieve Life Sciences, Inc.: how it makes money

Achieve Life Sciences is developing cytisinicline, a plant-derived alkaloid for smoking cessation, through late-stage clinical trials in the U.S., Canada, and the U.K. The company has no product revenue and is funded entirely by equity issuance and license agreements. All enterprise value rests on one molecule clearing Phase 3 trials and earning regulatory approval, with no secondary pipeline to diversify that binary risk.

Every dollar of value is a bet on a single Phase 3 readout: if ORCA-3 fails, the engine has no fuel left.

Business quality (Unprofitable): Pre-revenue clinical-stage pharma; no margins, no cash flow, and a binary regulatory outcome define the entire risk-reward.

Bull case

  • Pivotal trial fully enrolled: ORCA-3 has reached 792 U.S. adult smoker participants, the registration study whose readout will determine the FDA approval pathway and unlock first commercial revenue for cytisinicline.
  • Long-term retention suggests durability: 75% of open-label study participants remain on cytisinicline after extended exposure, a meaningful safety and tolerability signal that supports the drug's case for sustained smoking-cessation benefit.

Bear case

  • No revenue, deep losses: Quarterly revenue is $0.0 billion and return on equity stands at negative 1,026.0%, meaning the company is burning cash on R&D with no product sales to offset clinical and admin costs.
  • Safety trial under-enrolled: ORCA-OL has enrolled 479 participants against a proposed 650 target, so the long-term safety dataset may be thinner than regulators expect, potentially delaying or complicating the approval package.
Valuation — source: SEC EDGAR (first-party)
Price$8.49
Market Cap$871.58M
Price / Sales316.48
FCF Yield-5.7%
Profitability & Growth — source: SEC EDGAR
Revenue (TTM)$1.50M
Net Margin-3655.4%
Revenue Growth (YoY)668.8%
EPS Growth (YoY)116.2%
Financial Health — source: SEC EDGAR
Altman Z-Score12.95 (safe)
Valuation vs Sector & Industry
Sector P/E (Healthcare)21.6
Industry P/E (Pharmaceutical Products)17.2
Company
SectorHealthcare
IndustryPharmaceutical Products
CEORichard A. Stewart
Employees25
CountryCA
IPO Date1997-03-19

Achieve Life Sciences, Inc. earnings call transcripts

  • ACHV Q1 FY25 earnings call transcript (reported 2025-05-13) · analysis

All ACHV earnings calls

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ACHV earnings history · ACHV institutional & insider holders · ACHV KPIs & operating metrics · ACHV financials · ACHV investor presentations & press releases · ACHV SEC filings · ACHV peers · Congress trades · Insider trades · Short interest · Stock screener

Data as of 2026-09-02.

Figures sourced from U.S. Securities and Exchange Commission (SEC EDGAR) filings and market data. Not personalized investment advice.