ACHIEVE LIFE SCIENCES, INC.
ACHV evidence brief
What we can confirm
What it means
What to watch
Prepared research question
What matters most for ACHV—catalysts, financial risk and supporting evidence?
Traceable citations · Unknowns marked
BioSniper AI · ACHV
Achieve Life Sciences is a late-stage specialty pharmaceutical company developing cytisinicline for smoking cessation and nicotine addiction, with no approved products or revenue to date.
Key risk: Going concern uncertainty
BioSniper Score
Based on 5 of 6 signals
Financial data as of Jun 30, 2026.
Tracking 1 pipeline candidate · 3 clinical trials for ACHIEVE LIFE SCIENCES, INC..
Similar companies
Achieve Life Sciences is a late-stage specialty pharmaceutical company developing cytisinicline for smoking cessation and nicotine addiction, with no approved products or revenue to date.
- Lead candidate cytisinicline is in late-stage development for smoking cessation and e-cigarette cessation, with a planned NDA submission and potential FDA approval in the first half of 2027 [sec_mda · as of 2026-08-11].
- Cash and equivalents were $48.0 million as of June 30, 2025, with a net loss of $74.8 million for the six months ended June 30, 2025 [sec].
- The company has an accumulated deficit of $245.6 million as of September 30, 2025, and has never generated product revenue [sec_mda · as of 2025-11-06].
- Management has expressed substantial doubt about the company's ability to continue as a going concern, citing insufficient resources to fund planned operations for the next 12 months [sec_mda · as of 2026-03-24].
What works
- Cytisinicline has demonstrated efficacy and a well-tolerated safety profile in clinical trials, with a flexible 6- or 12-week dosing regimen that may differentiate it from existing smoking cessation treatments [sec_mda · as of 2026-05-12].
- The company plans to commercialize cytisinicline independently in the U.S. using a targeted marketing approach and AI tools, supported by an integrated agency partnership with Omnicom [sec_mda · as of 2026-05-12].
- A commercial supply agreement with Adare is in place for manufacturing, and launch readiness activities are underway [sec_mda · as of 2026-08-11].
What to weigh
- The company has no approved products, no revenue from product sales, and has incurred operating losses since inception, with a net loss of $40.0 million for the nine months ended September 30, 2025 [sec_mda · as of 2025-11-06].
- Substantial doubt exists about the company's ability to continue as a going concern, as current resources are insufficient to fund planned operations for the next 12 months [sec_mda · as of 2026-03-24].
- The company has incurred substantial debt ($14.9 million total debt as of June 30, 2025 [sec]), which could impair financial flexibility and access to capital [sec_mda · as of 2026-03-24].
- Achieve Life Sciences will need to raise substantial additional capital through equity, debt, or partnerships to fund development and commercialization, and failure to do so could materially harm the business [sec_mda · as of 2025-11-06].
From the filings
Quoted directly from source documents.
Cytisinicline is differentiated from existing treatments due to efficacy, safety, and dosing flexibility.
“We believe cytisinicline is differentiated from existing smoking cessation treatments given its combination of efficacy, well-tolerated safety profile and dosing flexibility with a 6 or 12-week regimen, as demonstrated in clinical trials.”
SEC MD&A · May 12, 2026
Management has substantial doubt about the company's ability to continue as a going concern.
“Substantial doubt exists as to our ability to continue as a going concern. Our ability to continue as a going concern is subject to material uncertainty and dependent on our success at raising additional capital sufficient to meet our obligations on a timely basis.”
SEC MD&A · March 24, 2026
Current resources are insufficient to fund planned operations for the next 12 months.
“Our current resources are insufficient to fund our planned operations for the next 12 months. We will continue to require substantial additional capital to continue our clinical development activities and expand our regulatory, manufacturing and commercialization activities.”
SEC MD&A · March 24, 2026
Risks & what to watch (4)›
Key risks
- Going concern uncertainty — Substantial doubt exists about the company's ability to continue as a going concern; dependent on raising additional capital [sec_mda · as of 2026-03-24].
- No revenue or profitability — No approved products, no product revenue, and cumulative operating losses since inception [sec_mda · as of 2025-11-06].
- Need for substantial additional capital — Current resources insufficient for 12 months; must raise funds via equity, debt, or partnerships [sec_mda · as of 2026-03-24].
- Regulatory and commercial risk — Cytisinicline not yet FDA-approved; commercial success depends on approval and market adoption [sec_mda · as of 2026-08-11].
What to watch
- FDA acceptance and review of the cytisinicline NDA for smoking cessation, with potential approval in the first half of 2027 [sec_mda · as of 2026-08-11].
- The company's ability to raise additional capital to fund operations beyond the next 12 months [sec_mda · as of 2026-03-24].
- Progress of commercial launch readiness activities, including manufacturing scale-up and marketing infrastructure [sec_mda · as of 2026-05-12].
- Any clinical trial results or regulatory updates for cytisinicline in e-cigarette cessation or other indications [sec_mda · as of 2026-08-11].
Sources: SEC filings · SEC MD&A · Generated August 28, 2026 · How we verify sources →
Run ACHIEVE LIFE SCIENCES, INC. through your own thesis
Use the pipeline, catalyst, financial, FDA, and market facts on this page as inputs to a protocol you control.
Your protocol can:
- Turn available ACHIEVE LIFE SCIENCES, INC. facts into screen rules or deeper checks
- Show cited findings, blockers, and unresolved evidence together
- Save the logic and rerun it as the company evidence changes
Evidence & data
Score breakdownBased on 5 of 6 signals · derived from public data
50.3 months
OCF -$11M · Net income -$75M
Lead: Phase 3
1 candidate
No upcoming catalysts tracked
0 buys · 1 sell (180d)
Runway
Pipeline
Regulatory
Financials
Institutional Holdings
Source: SEC Form 13F · as of Mar 2026Institutional holders
79
Total value held
$56.4M
| Holder | Shares | Value |
|---|---|---|
| vanguard capital management llc | 4,409,428 | $13.0M |
| franklin resources inc | 4,369,193 | $12.8M |
| simplify asset management inc. | 1,184,512 | $3.5M |
| millennium management llc | 1,077,338 | $3.2M |
| marshall wace, llp | 1,019,281 | $3.0M |
| raymond james financial inc | 641,925 | $1.9M |
| geode capital management, llc | 622,785 | $1.8M |
| two sigma investments, lp | 588,551 | $1.7M |
| susquehanna international group, llp | 510,883 | $1.5M |
| kvp capital advisors, lp | 462,355 | $1.4M |
Showing top 10 of 79 institutional holders of ACHIEVE LIFE SCIENCES, INC.. Open the full 13F history after sign-in.
Short Interest
as of Apr 30, 2026- % of float
- 15.0%
- Days to cover
- 7.7
- Shares short
- 6,845,606
- Daily short volume
- -
Short percent of float and days-to-cover reflect reported short positioning. Daily short volume is the exchange-reported short share of a single day's trading volume and is noisier. See the most-shorted biotech ranking →
ACHV short interestGovernance
Frequently asked questions
What is the AI investment thesis for ACHIEVE LIFE SCIENCES, INC.?
Achieve Life Sciences is a late-stage specialty pharmaceutical company developing cytisinicline for smoking cessation and nicotine addiction, with no approved products or revenue to date.
What is ACHIEVE LIFE SCIENCES, INC.'s lead drug candidate?
ACHIEVE LIFE SCIENCES, INC.'s most advanced tracked candidate is cytisinicline (Phase 3) for Smoking Cessation.
Who is the CEO of ACHIEVE LIFE SCIENCES, INC.?
Dr. Andrew D. Goldberg M.D. is the chief executive officer of ACHIEVE LIFE SCIENCES, INC. (ACHV).
Where is ACHIEVE LIFE SCIENCES, INC. headquartered?
ACHIEVE LIFE SCIENCES, INC. (ACHV) is headquartered in Bothell, WA, United States.
What therapeutic areas does ACHIEVE LIFE SCIENCES, INC. focus on?
ACHIEVE LIFE SCIENCES, INC. develops therapies across Oncology, Psychiatry.
The AI overview and BioSniper Score are neutral, data-derived signals built from public SEC filings, ClinicalTrials.gov and FDA records — not investment advice.