Achieve Life Sciences Inc (ACHV)
NASDAQ:ACHV
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Achieve Life Sciences
(NASDAQ:ACHV)
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Rating:52Neutral
Price Target:
$4.50
▼(-11.76% Downside)
Action:ReiteratedDate:04/17/26
The score is held down primarily by weak financial performance (no revenue, sizable losses, and persistent cash burn). Partially offsetting this are tangible regulatory progress and a major financing event that improves the company’s ability to fund trials and commercialization, while technical indicators remain mixed and valuation lacks profitability or dividend support.
Positive Factors
Regulatory Clarity
Clear FDA acceptance and a firm PDUFA date materially reduce regulatory timing uncertainty and de-risk the approval pathway. Over the next 2-6 months this improves planning for commercialization, payer engagement, and partner commitments, strengthening the path to revenue realization.
Negative Factors
Pre-Commercial Financial Profile
No product revenue and recurring large annual losses mean the company remains fully reliant on external financing. This structural lack of operating cash flow increases dilution and financing pressure until commercial sales commence, affecting financial flexibility over the coming months.
Read all positive and negative factors
Positive Factors
Negative Factors
Regulatory Clarity
Clear FDA acceptance and a firm PDUFA date materially reduce regulatory timing uncertainty and de-risk the approval pathway. Over the next 2-6 months this improves planning for commercialization, payer engagement, and partner commitments, strengthening the path to revenue realization.
Read all positive factors
Achieve Life Sciences (ACHV) vs. SPDR S&P 500 ETF (SPY)
Market Cap
$233.19M
Dividend YieldN/A
Average Volume (3M)1.32M
Price to Earnings (P/E)―
Beta (1Y)2.62
Revenue GrowthN/A
EPS Growth-5.42%
CountryUS
Employees25
SectorHealthcare
Sector Strength45
IndustryBiotechnology
Share Statistics
EPS (TTM)-0.28
Shares Outstanding53,239,986
10 Day Avg. Volume2,377,942
30 Day Avg. Volume1,320,294
Financial Highlights & Ratios
PEG Ratio-4.92
Price to Book (P/B)10.07
Price to Sales (P/S)0.00
P/FCF Ratio-4.38
Enterprise Value/Market Cap0.92
Enterprise Value/RevenueN/A
Enterprise Value/Gross Profit-942.86
Enterprise Value/Ebitda-3.99
Forecast
1Y Price Target
$13.20Price Target Upside158.82% Upside
Rating ConsensusStrong Buy
Number of Analyst Covering5
EPS Forecast (FY)-1.32
Revenue Forecast (FY)N/A
Achieve Life Sciences Business Overview & Revenue Model
Company Description
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,...
How the Company Makes Money
Achieve Life Sciences is a development-stage biopharmaceutical company and, based on publicly available information, it does not have an approved product for sale. As a result, it generally does not generate recurring product revenue from commerci...
Achieve Life Sciences Earnings Call Summary
Earnings Call Date:Mar 24, 2026
(Q4-2025)
| % Change Since: |
Next Earnings Date:May 07, 2026
Earnings Call Sentiment Positive
The call conveyed meaningful progress on multiple strategic fronts: regulatory advancement (NDA acceptance and clear PDUFA date), an accelerated pathway for the vaping indication (CNPV), strong clinical and long-term tolerability data including peer-reviewed publication, commercial build-out using AI/digital capabilities, and steps to onshore manufacturing. Major risks highlighted include a limited cash balance relative to the current annualized burn (implying roughly an eight-month runway at current spend), GMP observations at a named manufacturer that introduce supply uncertainty, and the need for additional financing and payer access work ahead of a potential 1H 2027 launch. Overall, achievements and momentum around approval, clinical validation, and commercial preparation are substantial, but near-term financial and manufacturing risks are material and will require active management.Positive Updates
NDA Submission and FDA Acceptance
New Drug Application (NDA) for smoking cessation submitted June 2025 and accepted by the FDA; PDUFA date set for June 20, 2026, putting the company on a clear regulatory path toward a potential approval that could be the first new FDA-approved nicotine dependence treatment in ~20 years.
Negative Updates
Limited Cash Position vs. Run-Rate
Cash, cash equivalents, and marketable securities totaled $36.4 million as of December 31, 2025, while total operating expenses for the full year were $54.9 million. At the current burn rate (~$4.58 million/month), this implies roughly an ~8-month runway (36.4 / (54.9/12) ≈ 7.96 months). Management is evaluating financing options.
Read all updates
Q4-2025 Updates
Positive
Negative
NDA Submission and FDA Acceptance
New Drug Application (NDA) for smoking cessation submitted June 2025 and accepted by the FDA; PDUFA date set for June 20, 2026, putting the company on a clear regulatory path toward a potential approval that could be the first new FDA-approved nicotine dependence treatment in ~20 years.
Read all positive updates
Company Guidance
Guidance from the call centered on a clear regulatory and commercial timeline and readiness metrics: the NDA for smoking cessation was submitted in June 2025 and is on a PDUFA target of June 20, 2026, the vaping indication received a Commissioner’s National Priority Voucher that can shorten review to ~1–2 months versus a typical 10–12 months, and the ORCA‑V2 Phase III vaping trial is being readied to start in H1 2026; management is targeting a commercial launch in 1H 2027. Operational and supply guidance included a U.S. manufacturing transfer to Adare (to be added to the NDA in Q3 2026), a third‑party manufacturer with 2 GMP inspection observations under remediation, more than three years of starting‑material stockpiled (3‑year shelf life), over half of required state licenses secured, 3PL and specialty‑pharmacy setups underway, and plans to have product in channel to begin demand build. Financial and clinical metrics cited to frame readiness: cash, cash equivalents and marketable securities of $36.4M as of 12/31/25; operating expenses of $14.7M (Q4) and $54.9M (FY 2025) and net losses of $14.7M (Q4) and $54.7M (FY); clinical program pooled data from >1,600 Phase III participants, ORCA‑OL long‑term exposure to 52 weeks with adherence >75%; and market opportunity figures of ~25M U.S. adult smokers, nearly 18M adult e‑cigarette users (≈60% want to quit) and ~6M COPD smokers—all supported by ~40 payer touch points in Q1 as the company finalizes pricing, access and launch plans.Achieve Life Sciences Financial Statement Overview
Summary
Income Statement
12
Very Negative
Balance Sheet
38
Negative
Cash Flow
20
Very Negative
| Breakdown | Dec 2025 | Dec 2024 | Dec 2023 | Dec 2022 | Dec 2021 |
|---|---|---|---|---|---|
Income Statement | |||||
| Total Revenue | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 |
| Gross Profit | -228.00K | -229.00K | 0.00 | 0.00 | 0.00 |
| EBITDA | -54.65M | -37.42M | -26.73M | -40.33M | -32.90M |
| Net Income | -54.65M | -39.83M | -29.82M | -42.35M | -33.15M |
Balance Sheet | |||||
| Total Assets | 41.79M | 38.63M | 19.37M | 29.97M | 47.52M |
| Cash, Cash Equivalents and Short-Term Investments | 36.40M | 34.36M | 15.55M | 24.72M | 43.02M |
| Total Debt | 14.96M | 9.96M | 16.73M | 16.20M | 14.99M |
| Total Liabilities | 20.27M | 17.73M | 20.82M | 21.67M | 19.47M |
| Stockholders Equity | 21.52M | 20.90M | -1.45M | 8.30M | 28.04M |
Cash Flow | |||||
| Free Cash Flow | -49.47M | -29.77M | -24.50M | -37.57M | -29.44M |
| Operating Cash Flow | -49.47M | -29.77M | -24.48M | -37.57M | -29.44M |
| Investing Cash Flow | 6.11M | -21.58M | -21.00K | 0.00 | 0.00 |
| Financing Cash Flow | 51.53M | 48.53M | 15.28M | 19.32M | 36.61M |
Achieve Life Sciences Technical Analysis
Positive
5.10
Price Trends
3.95
Positive
4.37
Positive
3.83
Positive
Market Momentum
0.10
Negative
74.48
Negative
81.55
Negative
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For ACHV, the sentiment is Positive. The current price of 5.1 is above the 20-day moving average (MA) of 3.42, above the 50-day MA of 3.95, and above the 200-day MA of 3.83, indicating a bullish trend. The MACD of 0.10 indicates Negative momentum. The RSI at 74.48 is Negative, neither overbought nor oversold. The STOCH value of 81.55 is Negative, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Positive sentiment for ACHV.
Achieve Life Sciences Risk Analysis
Achieve Life Sciences disclosed 130 risk factors in its most recent earnings report. Achieve Life Sciences reported the most risks in the "Finance & Corporate" category.
Finance & Corporate - Financial and accounting risks. Risks related to the execution of corporate activity and strategy
Latest Risks Added 0 New Risks
Achieve Life Sciences Peers Comparison
UnderperformOutperform
Sector (51)
Name | Overall Rating | Market Cap | P/E Ratio | ROE | Dividend Yield | Revenue Growth | EPS Growth |
|---|---|---|---|---|---|---|---|
53 Neutral | $143.57M | 15.23 | 22.53% | ― | 117.62% | ― | |
53 Neutral | $208.88M | -1.32 | -30.02% | ― | ― | 15.26% | |
52 Neutral | $233.19M | -3.96 | -204.14% | ― | ― | -5.42% | |
51 Neutral | $7.86B | -0.30 | -43.30% | 2.27% | 22.53% | -2.21% | |
50 Neutral | $282.06M | -7.16 | -69.63% | ― | 76.18% | -109.46% | |
50 Neutral | $220.04M | -2.69 | -656.82% | ― | ― | -10.20% |
* Healthcare Sector Average
ACHV
Achieve Life Sciences
4.38
1.74
65.91%
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MIST
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NKTX
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47.98%
Achieve Life Sciences Corporate Events
Business Operations and StrategyExecutive/Board ChangesPrivate Placements and Financing
Achieve Life Sciences Raises Capital, Appoints New CEO
Positive
Apr 16, 2026
On April 15 and 16, 2026, Achieve Life Sciences, Inc. announced a substantial private placement and leadership changes as it advances cytisinicline toward potential approval. The company entered a securities purchase agreement with leading healthc...
Glossary
BuyA stock rated as a "Buy" is expected to perform better than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock is likely to deliver higher returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
HoldA stock rated as a "Hold" is expected to perform in line with the overall market or a specific benchmark. This rating indicates that the stock is neither particularly compelling nor unfavorable for investment. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
SellA stock rated as a "Sell" is expected to perform worse than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock may deliver lower returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
Disclaimer
This AI Analyst Stock Report is automatically generated by our AI systems using advanced algorithms and publicly available financial, technical, and market data. While the information provided aims to be accurate and insightful, it is intended for informational purposes only and should not be considered financial advice. Any content created by an AI (Artificial Intelligence) system may contain inaccuracies and/or contain errors. Investing in stocks carries inherent risks, and past performance is not indicative of future results. This report does not account for your personal financial circumstances, objectives, or risk tolerance. Always conduct your own research or consult with a qualified financial advisor before making investment decisions. The analysis and recommendations provided are based on historical and current data and may not fully reflect future market conditions or unexpected developments. Neither the creators of this report nor its affiliated entities guarantee the accuracy, completeness, or reliability of the information presented. Use this report at your own discretion and risk.