olivLaw · US equity research
Achieve Life Sciences, Inc. ACHV
In Vitro & In Vivo Diagnostic Substances · SIC 2835 · Vertical: In Vitro & In Vivo Diagnostic Substances (SIC 2835)
Achieve Life Sciences is a late-stage specialty pharmaceutical company developing cytisinicline for nicotine dependence, covering both smoking and e-cigarette cessation. The company received a Complete Response Letter from the FDA in June 2026 tied to manufacturing issues rather than efficacy or safety, and a private placement of up to 354 million USD now supports preparation of a resubmission.
At the close of 04 Nov 2026, Achieve Life Sciences, Inc. (ACHV) stock was 6.98 USD (+3.71% on the day), with market capitalisation 718.3 m USD, beta 1.37, 52-week range 2.65–8.53 USD. Latest reported quarter (Q2 2026): net income of -74.8 m USD, diluted EPS -0.80 USD.
Data as of · AI analysis dated · Source: SEC filings and closing prices, computed by olivLaw.
Price history
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Technical reading
- RSI (14)
- 50.3
- neutral
- Bollinger (20, 2)
- 6.25 – 7.38
- in the upper half of the band · %B 0.65 · band width 16.5%
- SMA 50 / 200
- 7.38 / 5.68
- mixed trend
- MACD (12, 26, 9)
- -0.13 / -0.18
- MACD above signal
Indicators describe past prices; on their own they do not predict direction. On our history the RSI ≤ 40 filter added no return (see the signals methodology).
Performance
| Company | S&P 500 | vs S&P 500 | Vertical median | |
|---|---|---|---|---|
| 1 month | −0.4% | −1.1% | +0.7 pp | — |
| 3 months | +4.8% | −0.5% | +5.3 pp | — |
| 6 months | +45.4% | +4.4% | +41.0 pp | — |
| Year to date | +40.4% | +12.3% | +28.1 pp | — |
| 1 year | +45.1% | +13.5% | +31.6 pp | −26.8% |
| 3 years | +63.1% | +76.4% | −13.3 pp | −63.5% |
| 5 years | −19.0% | +63.7% | −82.7 pp | — |
Price returns, dividends excluded.
Quarterly results
Latest quarter: Q2 2026 · 30 Jun 2026
Quarterly statements · USD
| Fiscal year | Q3 '24 | Q4 '24 | Q1 '25 | Q2 '25 | Q3 '25 | Q4 '25 | Q1 '26 | Q2 '26 |
|---|---|---|---|---|---|---|---|---|
| Research & development | 7.6 m | 7.3 m | 7.1 m | 6.7 m | 5.3 m | — | — | — |
| Depreciation & amortisation | 57.0 k ≈ | 58.0 k | 62.0 k | 55.0 k ≈ | 54.0 k ≈ | 57.0 k | 57.0 k | 58.0 k ≈ |
| Interest expense | 366.0 k | 197.0 k | 185.0 k | 191.0 k | 192.0 k | 251.0 k | 274.0 k | 277.0 k |
| Net income | -12.5 m | -12.4 m | -12.8 m | -12.7 m | -14.4 m | -14.7 m | -10.2 m | -74.8 m |
| Diluted EPS | -0.36 | -0.36 ≈ | -0.37 | -0.37 | -0.28 | -0.27 ≈ | -0.19 | -0.80 |
| Operating cash flow | -10.4 m ≈ | -9.2 m | -11.1 m | -9.1 m ≈ | -11.3 m ≈ | -18.0 m | -6.9 m | -10.8 m ≈ |
≈ derived quarter (cumulative difference / share-days average)
E/P over time
E/P = trailing-12-month diluted EPS / price at quarter end. E/P is the inverse of P/E and stays defined when earnings are negative.
Fiscal years
| Fiscal year | 2018 | 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 |
|---|---|---|---|---|---|---|---|---|
| Revenue | 0 | 0 | unavailable | unavailable | unavailable | unavailable | unavailable | unavailable |
| Revenue YoY | unavailable | unavailable | unavailable | unavailable | unavailable | unavailable | unavailable | unavailable |
| Net income | -12.7 m | -16.4 m | -14.7 m | -33.2 m | -42.4 m | -29.8 m | -39.8 m | -54.6 m |
| Net income YoY | unavailable | unavailable | unavailable | unavailable | unavailable | unavailable | unavailable | unavailable |
| Diluted EPS | unavailable | unavailable | -5.42 | -4.08 | -4.00 | -1.50 | -1.24 | -1.25 |
| Diluted EPS YoY | unavailable | unavailable | unavailable | unavailable | unavailable | unavailable | unavailable | unavailable |
| net % | unavailable | unavailable | unavailable | unavailable | unavailable | unavailable | unavailable | unavailable |
| Free cash flow | -10.7 m | -15.3 m | -13.5 m | unavailable | unavailable | -24.5 m | unavailable | -49.5 m |
Reported results vs expectations
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Balance sheet & financial health
Fiscal year 2025 · 31 Dec 2025
- Cash
- 20.9 m USD
- Financial debt
- unavailable USD
- Net debt
- unavailable USD
- Equity
- 21.5 m USD
- Total assets
- 41.8 m USD
- Debt / equity
- unavailable
- Current ratio
- 4.39x
- ROE
- -257.7%
- ROA
- -135.9%
- FCF margin
- unavailable
Financial statements (source on every figure)
Revenue and net income (USD)
Income statement · USD
| Line | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 | Source (latest year) |
|---|---|---|---|---|---|---|---|
| Research & development | 6.9 m | 24.0 m | 30.1 m | 15.8 m | 22.8 m | — | SEC (XBRL)· 11 Mar 2025verified |
| Depreciation & amortisation | 255.0 k | 250.0 k | 236.0 k | 228.0 k | 229.0 k | 228.0 k | SEC (XBRL)· 24 Mar 2026verified |
| Interest expense | — | — | 1.8 m | 2.9 m | 2.2 m | 819.0 k | SEC (XBRL)· 24 Mar 2026verified |
| Pre-tax income | -14.7 m | -33.2 m | -42.4 m | -29.8 m | -39.8 m | -54.6 m | SEC (XBRL)· 24 Mar 2026verified |
| Net income | -14.7 m | -33.2 m | -42.4 m | -29.8 m | -39.8 m | -54.6 m | SEC (XBRL)· 24 Mar 2026verified |
| Diluted EPS | -5.42 | -4.08 | -4.00 | -1.50 | -1.24 | -1.25 | SEC (XBRL)· 24 Mar 2026verified |
| Weighted average diluted shares | 2.7 m | 8.1 m | 10.6 m | 19.8 m | 32.1 m | 43.6 m | SEC (XBRL)· 24 Mar 2026verified |
Balance sheet · USD
| Line | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 | Source (latest year) |
|---|---|---|---|---|---|---|---|
| Cash | 35.9 m | 43.0 m | 24.8 m | 15.5 m | 12.8 m | 20.9 m | SEC (XBRL)· 24 Mar 2026verified |
| Current assets | 37.0 m | 44.6 m | 27.3 m | 17.0 m | 36.5 m | 39.9 m | SEC (XBRL)· 24 Mar 2026verified |
| Property, plant & equipment, net | 42.0 k | 15.0 k | 4.0 k | 13.0 k | 8.0 k | 3.0 k | SEC (XBRL)· 24 Mar 2026verified |
| Goodwill | 1.0 m | 1.0 m | 1.0 m | 1.0 m | 1.0 m | 1.0 m | SEC (XBRL)· 24 Mar 2026verified |
| Intangibles (excl. goodwill) | 1.9 m | 1.6 m | 1.4 m | 1.2 m | 974.0 k | 751.0 k | SEC (XBRL)· 24 Mar 2026verified |
| Total assets | 40.3 m | 47.5 m | 30.0 m | 19.4 m | 38.6 m | 41.8 m | SEC (XBRL)· 24 Mar 2026verified |
| Accounts payable | 332.0 k | 841.0 k | 1.7 m | 618.0 k | 2.0 m | — | SEC (XBRL)· 11 Mar 2025verified |
| Current liabilities | 2.9 m | 4.6 m | 21.6 m | 20.8 m | 6.7 m | 9.1 m | SEC (XBRL)· 24 Mar 2026verified |
| Total liabilities | 3.0 m | 19.5 m | 21.7 m | 20.8 m | 17.7 m | 20.3 m | SEC (XBRL)· 24 Mar 2026verified |
| Equity | 37.3 m † | 28.0 m † | 8.3 m † | -1.4 m † | 20.9 m † | 21.5 m † | SEC (XBRL)· 24 Mar 2026verified |
† equity attributable to the parent's shareholders: in these years the issuer no longer reports the total including non-controlling interests.
Cash flow · USD
| Line | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 | Source (latest year) |
|---|---|---|---|---|---|---|---|
| Operating cash flow | -13.5 m | -29.4 m | -37.6 m | -24.5 m | -29.8 m | -49.5 m | SEC (XBRL)· 24 Mar 2026verified |
| Capex | 17.0 k | — | — | 21.0 k | — | 3.0 k | SEC (XBRL)· 24 Mar 2026verified |
| Free cash flow | -13.5 m ≈ | — | — | -24.5 m ≈ | — | -49.5 m ≈ | SEC (XBRL)· 24 Mar 2026derived |
| Investing cash flow | -17.0 k | — | — | -21.0 k | -21.6 m | 6.1 m | SEC (XBRL)· 24 Mar 2026verified |
| Financing cash flow | 32.7 m | 36.6 m | 19.3 m | 15.3 m | 48.5 m | 51.5 m | SEC (XBRL)· 24 Mar 2026verified |
≈ computed by olivLaw from the reported lines of the same year: Operating cash flow − Capex.
Computed indicators
Growth
Profitability
Returns
Balance sheet
Liquidity
Cash
Efficiency
Market and valuation
1 indicators that do not apply to the sector.
Valuation
olivLaw classification
- indicators available: 2 of at least 6
- score weight coverage: 12.5% of at least 60%
- valuation methods computed: 0 of at least 1
A scoring methodology on indicators and valuation, not investment advice.
Closing price
04 Nov 2026Source: olivLaw, closing series
Market cap: 718.3 m USD
Key indicators
Coverage and freshness
Score by group
13% · Insufficient data
Estimated value range
unavailable — no valuation method could be computed
Valuation assumptions are editorial choices, not measured; beta is not measured.
Valuation methods
- DCF (discounted cash flow)unavailable · input data missing
- Peers: EV/EBITDAunavailable · net debt missing: EV cannot be bridged to equity (missing debt is not zero)
- Peers: P/Eunavailable · the base of the ratio is not positive
- Dividend discount (DDM)unavailable · the company pays no dividend: a dividend model needs an explicit initiation assumption
no valuation method could be computed
Classification (SIC) comparables group by industry code, not by economic activity; the direct group is an editorial selection by activity. Members' multiples are on their own trailing twelve months, at their own latest close.
Assumptions (illustrative, editorial)
- Risk-free rate
- 4.3%
- Equity risk premium
- 5.0%
- Beta (default)
- 1.00
- Cost of equity
- 9.3%
- Terminal growth
- 2.5%
Factor scorecard
Insufficient data
Minimum-evidence gate: indicators available: 2 of at least 6; score weight coverage: 12.5% of at least 60%; valuation methods computed: 0 of at least 1
| Factor | Value | Score | Weight used |
|---|---|---|---|
| ROIC · Quality | unavailable | unavailable | — |
| Net margin · Quality | unavailable | unavailable | — |
| FCF conversion · Quality | unavailable | unavailable | — |
| Revenue CAGR 3Y · Growth | unavailable | unavailable | — |
| EPS CAGR 3Y · Growth | unavailable | unavailable | — |
| Net debt / EBITDA · Balance sheet | unavailable | unavailable | — |
| Interest coverage · Balance sheet | unavailable | unavailable | — |
| Current ratio · Balance sheet | 1.0x | 13 (on a fixed band) | 33% |
| P/E (TTM) · Valuation | unavailable | unavailable | — |
| EV/EBITDA · Valuation | unavailable | unavailable | — |
| FCF yield · Valuation | -6.5% | 0 (on a fixed band) | 67% |
| Shareholder yield (distributions) · Returns | unavailable | unavailable | — |
| Payout ratio (FCF) · Returns | unavailable | unavailable | — |
Factors without a value were dropped; the remaining weights were renormalised.
Score groups
- Balance sheet· partial13/100 · 1/3 factors with a value
- Growth· partialunavailable · 0/2 factors with a value
- Quality· partialunavailable · 0/3 factors with a value
- Returns· partialunavailable · 0/2 factors with a value
- Valuation· partial0/100 · 1/3 factors with a value
A «partial» group is computed from under half of its weight or from one factor: it is not a full assessment of the group.
Memo
Achieve Life Sciences, Inc. (ACHV). Latest full fiscal year: 2019; data up to 2026-06-30.
Figures computed from the financial statements: ROE -845.0%.
Valuation cannot be computed from the available data.
Insufficient data for a verdict (indicators available: 2 of at least 6; score weight coverage: 12.5% of at least 60%; valuation methods computed: 0 of at least 1).
Text generated deterministically from the figures shown; no language model. Not investment advice.
What supports the thesis
No signal among the computed factors. That is not an absence of risk: factors without data were not assessed, and business risks (margins, inventory, demand) are in the source-based analysis.
What contradicts it
- Current ratio: 1.0x
- FCF yield: -6.5%
Not assessed (insufficient data or a ratio without meaning): ROIC, Net margin, FCF conversion, Revenue CAGR 3Y, EPS CAGR 3Y, Net debt / EBITDA, Interest coverage, P/E (TTM), EV/EBITDA, Shareholder yield (distributions), Payout ratio (FCF).
Versus the vertical median
In Vitro & In Vivo Diagnostic Substances (SIC 2835) · same industry (4-digit SIC) · compared with 17 companies
Multiples and returns vs the median
Price rebased to 100 (monthly, 5 years)
Companies in the vertical
| Market cap | P/E | ROE | Net margin | Revenue YoY | 1A / 3A | |
|---|---|---|---|---|---|---|
| IDXXIdexx Laboratories Inc | 55.0 bn | 47.1 | 68.9% | 25.4% | +10.4% | −7% / +50% |
| LNTHLantheus Holdings, Inc. | 6.6 bn | 24.5 | 22.2% | 17.7% | +0.5% | +72% / +41% |
| NEOGNeogen Corporation | 2.7 bn | — | -2.7% | -6.3% | −2.7% | +108% / −27% |
| TRIBTrinity Biotech PLC | 2.4 bn | — | — | -51.6% | +8.3% | −80% / −91% |
| CLDXCelldex Therapeutics, Inc. | 2.4 bn | — | -43.9% | -190,220.9% | −78.0% | +11% / −1% |
| NTLAIntellia Therapeutics, Inc. | 1.7 bn | — | -6,424.8% | -672.2% | +16.9% | +37% / −58% |
| QDELQuidelortho Corp | 984.6 m | — | -19.3% | -14.2% | −1.9% | −48% / −79% |
| ACHVAchieve Life Sciences, Inc. | 718.3 m | — | -845.0% | — | unavailable | +45% / +63% |
| MYGNMyriad Genetics, Inc. | 575.8 m | — | -32.5% | -14.0% | −1.6% | −21% / −68% |
| TKNOAlpha Teknova, Inc. | 395.7 m | — | -24.2% | -38.4% | +7.4% | +57% / +261% |
| ICCCImmuCell Corporation | 94.2 m | 138.2 | 2.6% | 2.6% | +4.3% | +114% / +128% |
| IMDXInsight Molecular Diagnostics Inc. | 86.7 m | — | — | -2,955.6% | +115.6% | −57% / −30% |
| BMRABiomerica, Inc. | 8.0 m | — | -113.8% | -115.5% | −16.2% | −27% / −77% |
| CDIOCardio Diagnostics Holdings, Inc. | 4.9 m | — | -75.4% | -44,771.8% | −57.5% | −43% / −97% |
| QCLSQ/C Technologies, Inc. | 3.2 m | — | -155.0% | — | −5.3% | −89% / −100% |
| VNRXVolitionRx Limited | 2.8 m | — | — | -1,043.1% | +40.0% | −97% / −99% |
| VRAXVirax Biolabs Group Ltd | 695.1 k | — | -109.6% | -95,739.2% | −96.0% | −88% / −98% |
| NNNNAnbio Biotechnology | — | 25.0 | 27.0% | 74.1% | +5.6% | −84% / unavailable |
1- and 3-year price returns: for ACHV from daily closes (the same as the performance table), for the other companies from month-end closes.
olivLaw engine forecast
The world engine ran after the company's latest material disclosure. Probabilities are of TOUCHING a level within the horizon (not closing there) and sit next to the random walk (p_rw), the no-information benchmark.
The engine has no published run for this company yet.
Valuation scenarios (editable assumptions)
Illustrative scenarios
Scenarios are not available. input data missing
AI analysis
AI-generatedAI-generated analysis (Claude) from cited public sources; it may contain errors. Not investment advice. As of 27 Oct 2026 · Model: claude-haiku-5-5.
In brief
Achieve Life Sciences is a late-stage specialty pharmaceutical company developing cytisinicline for nicotine dependence, covering both smoking and e-cigarette cessation. The company received a Complete Response Letter from the FDA in June 2026 tied to manufacturing issues rather than efficacy or safety, and a private placement of up to 354 million USD now supports preparation of a resubmission.
SWOT
Strengths
- The substance has more than two decades of use in Central and Eastern Europe, providing a safety and clinical experience base 1.
- The company holds Breakthrough Therapy designation and a national priority voucher for vaping, which could speed review 1.
- The Complete Response Letter raised no question about clinical efficacy or safety, and long-term safety data have already been presented 2.
Weaknesses
- The company has no approved products and no product revenue, and its losses are recurring 12.
- Reliance on third parties for manufacturing has already led to a Complete Response Letter and quality issues at a prior supplier 2.
- Working capital turned negative by June 30, 2026, and convertible debt remains on the balance sheet 2.
Opportunities
- A possible approval for smoking cessation could open the US commercial market if the Adare manufacturing is accepted 2.
- Extension to vaping cessation, if the Phase 3 trial succeeds, could address an unmet medical need 1.
- The private placement, if fully realized, could fund further trials and commercial launch 3.
Risks
- Going concernhigh
The company states there is substantial doubt about its ability to continue as a going concern and depends on raising additional capital 1.
- Complete Response Letterhigh
The June 2026 letter related to cGMP observations and labeling, and a resubmission could be delayed 2.
- Contract dispute with Sopharmamedium
Sopharma filed an arbitration demand in July 2026 alleging breach of the supply agreement, and the outcome is uncertain 2.
- Debt and covenantsmedium
The debt is secured by substantially all assets other than intellectual property, and a breach of covenants could lead to enforcement against those assets 1.
- Dilution of shareholdersmedium
Additional financing through shares or warrants could significantly dilute existing shareholders 12.
Investment thesis
What would need to be true (bull case)
- If the resubmitted NDA is accepted, the company could enter the US market with a product whose safety profile is already documented.
- The national priority voucher for vaping could accelerate review if a complete application is filed.
- The private placement could fund commercial preparation and the ORCA-V2 trial, easing near-term capital pressure.
What would break the thesis
- The company has no revenue, and without approval it could keep reporting large losses and depend on new financing.
- Manufacturing problems have already led to a Complete Response Letter, and a further delay could reduce investor confidence.
- The dispute with partner Sopharma could complicate access to existing data and the supply chain.
What to watch
- Resubmission of the NDA naming Adare as manufacturerQ4 2026
- FDA decision on cytisinicline for smoking cessationfirst half of 2027
- Outcome of the arbitration initiated by Sopharma2027
Products, market & competition
AI-generatedAI-generated analysis (Claude) from cited public sources; it may contain errors. Not investment advice. As of 27 Oct 2026 · Model: claude-haiku-5-5.
The business
The most recent regulatory milestone is the Complete Response Letter received from the FDA in June 2026, which related to cGMP observations at a prior third-party manufacturer and to final product labeling, not to clinical efficacy or safety 2. The company moved finished drug product manufacturing to Adare Pharma Solutions in the US and intends to resubmit the NDA in the fourth quarter of 2026, with potential approval in the first half of 2027 2.
For vaping cessation, cytisinicline has received Breakthrough Therapy designation and a Commissioner's National Priority Voucher, but no application for that indication has yet been filed 1. The company relies on proceeds from its private placement, and debt servicing and the absence of revenue remain important risks 12.
Segments
E-cigarette (vaping) cessation
The vaping indication is at an earlier stage, with a single Phase 3 trial proposed, and the company received Breakthrough Therapy designation in July 2024 1. No application for this indication has yet been filed, so it contributes no revenue in the periods reviewed 1.
Licensing and partnerships
The company relies on its license and supply agreement with Sopharma for territories outside Sopharma's, but a dispute over third-party manufacturers led Sopharma to file an arbitration demand in July 2026 2. For manufacturing, the partnership with Adare is central to the US supply plan 2.
Market context
Trends
- FDA priority reviewtailwind
The national priority voucher awarded for vaping could shorten FDA decision timelines if a complete application is filed 1.
- Pharmaceutical tariff pressureheadwind
Discussion of tariffs on pharmaceutical products could affect the supply chain and costs, which is why the company moved manufacturing to the US 1.
- Difficult financing environmentheadwind
The financing environment for biotechnology companies is challenging, which could make raising capital on favorable terms harder 1.
- Demand for nicotine dependence treatmentsmixed
Concern about e-cigarette use among adolescents could increase interest in targeted treatments if regulators and clinicians shift priorities 12.
Competitive position
The source texts do not identify specific direct competitors or analyse competing products. They note only that no FDA-approved therapy is currently indicated specifically for nicotine e-cigarette cessation 1.
The company argues that cytisinicline differs from existing treatments through its combination of efficacy, safety profile and dosing flexibility, though this comparison has not been independently verified against other available therapies 1.
- Existing smoking cessation treatments
The sources do not name manufacturers; the company only says cytisinicline differs from current treatments.
- OTC smoking cessation products
The sources mention OTC products only as a reference point for the limits of existing treatments.
- Other vaping cessation options
No FDA-approved vaping treatment exists, so direct competition for this indication is limited.
- Sopharma AD
The Central and Eastern European partner already marketing cytisinicline and currently in a contract dispute with the company.
Links, dependencies and risks
Who the company is tied to, from its own SEC filings (customers, suppliers, production, partners, competitors, countries, regulation), from the 5 %+ holders' statements (13D/13G) and from what other companies say about it. Click a node for its evidence; on a listed company the graph moves to it.
Loading the links…
News & filings
In the press
No news in our archive over the last 180 days.
SEC filings
- Current report01 Oct 2026Departure or appointment of officers
- Current report14 Aug 2026Other events · Financial statements and exhibits
- Quarterly report11 Aug 2026
- Current report11 Aug 2026Results of operations · Financial statements and exhibits
- Current report06 Jul 2026Amendments to articles or bylaws · Shareholder vote · Financial statements and exhibits
- Proxy statement08 Jun 2026
- Current report02 Jun 2026Departure or appointment of officers
- Quarterly report12 May 2026
- Current report12 May 2026Results of operations · Departure or appointment of officers · Financial statements and exhibits
- Current report16 Apr 2026Material agreement · Item 3.02 · Departure or appointment of officers · Regulation FD disclosure · Financial statements and exhibits
Sources
- [1] Form 10-K, fiscal year ended 2025-12-31 · SEC / Achieve Life Sciences, Inc. · 24 Mar 2026
- [2] Form 10-Q, quarter ended 2026-06-30 · SEC / Achieve Life Sciences, Inc. · 11 Aug 2026
- [3] Form 8-K, results release (exhibit 99.1) · SEC / Achieve Life Sciences, Inc. · 11 Aug 2026
Figures computed by olivLaw from SEC filings and closing prices; the qualitative analysis is AI-generated from cited sources. Not investment advice.