Achieve Life Science

What Achieve Life Science does

Achieve Life Sciences (NASDAQ: ACHV) is a late-stage specialty pharmaceutical company developing cytisinicline, a plant-derived alkaloid that acts as a partial agonist at α4β2 nicotinic acetylcholine receptors, for the treatment of nicotine dependence. The drug candidate reduces both the withdrawal symptoms and the reward/satisfaction associated with smoking and vaping by binding to the same receptors targeted by nicotine. The clinical development program spans five trials with 1,500+ exposed participants, including the positive Phase 3 ORCA-2 (810 subjects) and ORCA-3 (792 subjects) trials in adult smokers, where 12-week cytisinicline treatment demonstrated 30.3% continuous abstinence versus 9.4% on placebo (4.4x higher odds, p<0.0001) and a favorable tolerability profile with only 2.5% nausea over 52 weeks of continuous exposure. The Phase 2 ORCA-V1 trial in 160 adult e-cigarette users showed 2.6x higher odds of quitting vaping versus placebo (31.8% vs 15.1%, p=0.035), supporting a vaping cessation indication that has received FDA Breakthrough Therapy Designation and a Commissioner's National Priority Voucher.

The company submitted its cytisinicline NDA for smoking cessation in June 2025, which the FDA accepted in September 2025 with a PDUFA date of June 20, 2026. In June 2026, the FDA issued a Complete Response Letter citing third-party manufacturing facility deficiencies (no clinical efficacy or safety deficiencies identified); Achieve plans to resubmit in Q4 2026 using Adare Pharma Solutions as its new U.S. commercial manufacturer, with potential approval targeted for H1 2027. The company is pre-revenue, with FY2025 net loss of $54.6M and Q1 2026 net loss of $10.2M against $29.3M cash, and is funded to commercial launch primarily through an April 2026 private placement of up to $354M ($180M upfront) led by Frazier Life Sciences, TPG Life Sciences Innovations, venBio Partners, Paradigm BioCapital, and Marshall Wace.

Name

Achieve Life Science

Legal name

Achieve Life Sciences, Inc.

Website

https://achievelifesciences.com

Company type

Public

Founded year

1991

Operating status

Operating

Headcount range

11–50 employees

Short description

Achieve Life Sciences is a late-stage specialty pharmaceutical company developing cytisinicline, a plant-based alkaloid partial agonist at nicotinic receptors, for adult smoking and vaping cessation in the United States.

Ownership category

akta.pro rank

Product category

Smoking Cessation Pharmaceuticals

NAICS

Pharmaceutical Preparation Manufacturing (325412), Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

Pharmaceutical Preparations (2834)

akta.pro primary industry

Neurology & CNS Specialty Pharmaceuticals (HLAIACAC)

akta.pro secondary industries

Regulatory Strategy & IND/NDA/BLA Submissions Support (HLAIALAH), Clinical Development (Phase I–III Trial Design & Execution) (HLAIALAE)

Keywords

• Smoking cessation therapy
• Nicotine dependence treatment
• Specialty pharmaceutical
• Cytisinicline drug development
• Vaping cessation drug

Headquarters

HQ city

Mill Valley

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2C

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales, Others

Revenue model

1. Cytisinicline Commercialization: Achieve Life Sciences is a late-stage specialty pharmaceutical company developing cytisinicline for nicotine dependence. The company is preparing for commercial launch following FDA approval, which is expected in the first half of 2027. The company is pre-revenue as of 2026.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels5 records

Core offering

Achieve Life Sciences is a late-stage specialty pharmaceutical company developing cytisinicline, a plant-based alkaloid that acts as a partial agonist at nicotinic acetylcholine receptors to treat nicotine dependence in adult smokers and e-cigarette users. The company's primary value is the drug candidate itself, supported by a five-trial clinical development program (ORCA-1, ORCA-2, ORCA-3, ORCA-V1, ORCA-OL) and an NDA currently pending resubmission with the FDA. Once approved, cytisinicline is intended to be prescribed by healthcare providers and dispensed through specialty pharmacies as the first new FDA-approved smoking cessation therapy in over two decades.

Product overview

Achieve Life Sciences is a late-stage specialty pharmaceutical company developing a single drug candidate, cytisinicline, for the treatment of nicotine dependence. Cytisinicline is supported by an extensive clinical development program consisting of five trials: the Phase 3 ORCA-2 and ORCA-3 trials for smoking cessation, the Phase 2b ORCA-1 dose-finding study, the Phase 2 ORCA-V1 trial for vaping cessation, and an open-label long-term safety study (ORCA-OL). The company's NDA for smoking cessation is under FDA review, and the vaping cessation indication has received Breakthrough Therapy Designation.

Differentiator

Problem solved

Functional benefit

Products and services

• Cytisinicline A plant-based alkaloid drug candidate with high binding affinity to nicotinic acetylcholine receptors, acting as a partial agonist to reduce nicotine withdrawal symptoms, cravings, and the reward/satisfaction associated with smoking and vaping. Developed for adult smoking cessation and e-cigarette cessation indications, supported by the ORCA clinical program with over 1,500 participants exposed to date.

Quantifiable outcome

• 12-week cytisinicline treatment showed 4.4 times higher odds of quitting smoking (30.3% abstinence rate vs 9.4% placebo, p<0.0001)
• +3 more outcomes

Segments2 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

Two partnerships are on record, tiered core and major.

• Adare Pharma SolutionscoreStrategic or Co-development Partner · 15 April 2026U.S.-based manufacturing partner for cytisinicline drug product commercial supply. Achieve completed analytical method technology transfer to Adare's Vandalia, Ohio facility and successfully manufactured first engineering batch. This partnership addresses supply chain resilience and potential pharmaceutical import tariff concerns.
• OmnicommajorStrategic or Co-development Partner · 1 January 2025Partnership across multiple cross-functional agencies to create a data-driven commercial model designed to execute with precision, scale efficiently, and accelerate meaningful engagement for patients and providers.

Scale indicators7 records

Recent moves6 records

Expansion highlights6 records

Market position

Competitive moat4 records

Key risks6 records

Key highlights6 records

Customer concentration

• Xx.com/achievelifesci
• LinkedInlinkedin.com/company/achieve-life-sciences

Revenue estimate

Valuation estimate

Number of profiles

Profiles18 records

Funding overview

Funding rounds11 records

Investors20 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A1 record

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Achieve Life Science