Achieve Life Sciences (ACHV)
NASDAQ:ACHV
Want to see ACHV full AI Analyst Report?
Top Page
Achieve Life Sciences
(NASDAQ:ACHV)
Select Model
Select Model
Rating:55Neutral
Price Target:
$5.00
▼(-1.96% Downside)
Action:Reiterated
Date:05/15/26
Score is held back primarily by weak financial performance (no revenue, sizable losses, and ongoing cash burn with rising leverage). Offsetting this, the latest earnings call conveyed improved funding strength and credible execution plans alongside strong clinical efficacy, while technicals are supportive but appear overextended, and valuation remains constrained by losses.
Positive Factors
Phase III Clinical Efficacy
Robust, reproducible Phase III results—large absolute efficacy gap in difficult-to-treat subgroups—support a durable clinical differentiation versus placebo and prior therapies. That level of efficacy underpins commercial uptake, prescriber confidence, and long-term market positioning if regulatory approval is achieved.
Negative Factors
No Product Revenue and Persistent Losses
The company remains pre-revenue with substantial recurring net losses that translate into large cash outflows. Continued dependence on external capital to fund operations creates execution risk if financing windows tighten or approval timelines slip, pressuring strategic flexibility over the coming quarters.
Read all positive and negative factors
Positive Factors
Negative Factors
Phase III Clinical Efficacy
Robust, reproducible Phase III results—large absolute efficacy gap in difficult-to-treat subgroups—support a durable clinical differentiation versus placebo and prior therapies. That level of efficacy underpins commercial uptake, prescriber confidence, and long-term market positioning if regulatory approval is achieved.
Read all positive factors
Achieve Life Sciences (ACHV) vs. SPDR S&P 500 ETF (SPY)
Market Cap
$537.93M
Dividend YieldN/A
Average Volume (3M)1.41M
Price to Earnings (P/E)―
Beta (1Y)2.69
Revenue GrowthN/A
EPS Growth16.68%
CountryUS
Employees25
SectorHealthcare
Sector Strength45
IndustryBiotechnology
Share Statistics
EPS (TTM)-1.12
Shares Outstanding102,659,060
10 Day Avg. Volume1,410,816
30 Day Avg. Volume1,409,615
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 Cap0.98
Enterprise Value/RevenueN/A
Enterprise Value/Gross Profit-3.16K
Enterprise Value/Ebitda-10.21
Forecast
1Y Price Target
$13.20Price Target Upside158.82% Upside
Rating ConsensusStrong Buy
Number of Analyst Covering5
EPS Forecast (FY)-0.71
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:May 12, 2026
(Q1-2026)
| % Change Since: |
Next Earnings Date:Aug 06, 2026
Earnings Call Sentiment Positive
The call conveyed strong positive momentum: a substantial financing, experienced new leadership and commercial hires, U.S. manufacturing partnership with initial batches, robust Phase III efficacy (notably 32.4% vs 6% in hard-to-treat patients) and supportive mechanistic/tolerability data. The principal negatives are an anticipated FDA CRL tied to a third-party manufacturer OAI, requiring an NDA resubmission in Q4 2026 and introducing execution risk around the manufacturing tech transfer to Adare and timing uncertainty. Overall, the company appears well capitalized and operationally proactive to address the delays and pursue a planned H1 2027 launch, but near-term regulatory and manufacturing execution risks remain.Positive Updates
Transformational Financing
Completed a private placement providing $180 million in upfront capital plus up to $174 million in milestone-based warrants exercisable before and up to 20 trading days after FDA approval, supported by a syndicate of specialist healthcare investors (Frazier, TPG, venBio, Paradigm, Marshall Wace).
Negative Updates
Expected FDA Complete Response Letter (CRL) and Delay
Company announced it expects a CRL on or by the June 20 PDUFA date due to an official action indicated (OAI) classification at a separate third-party manufacturer; this necessitates an NDA resubmission in Q4 2026 and pushes projected approval/launch timing.
Read all updates
Q1-2026 Updates
Positive
Negative
Transformational Financing
Completed a private placement providing $180 million in upfront capital plus up to $174 million in milestone-based warrants exercisable before and up to 20 trading days after FDA approval, supported by a syndicate of specialist healthcare investors (Frazier, TPG, venBio, Paradigm, Marshall Wace).
Read all positive updates
Company Guidance
Achieve guided that it expects a complete response letter on or by its June 20, 2026 PDUFA date and plans to resubmit the NDA in Q4 2026 naming Adare as primary manufacturer (first Adare engineering batch completed in Q1 2026) with a targeted commercial launch in H1 2027; the company also expects to initiate the ORCA‑V2 vaping Phase III this year under its CNPV and breakthrough designations. Financially, the company closed a financing providing $180 million upfront plus up to $174 million of milestone-based warrants (exercisable any time prior to and up to 20 trading days following FDA approval). Key clinical/operational metrics cited include analysis of >1,600 Phase III participants, two Phase III double‑blind, placebo‑controlled trials in which both 6‑ and 12‑week courses were statistically significant, planned 52‑week safety/efficacy data later this year, and subgroup results showing 12‑week cytisinicline continuous abstinence of 32.4% versus 6% on placebo (OR 7.5); Achieve said it will commercialize independently with a scalable field force and believes its IP extends into the late 2030s/2040s.Achieve Life Sciences Financial Statement Overview
Summary
Income Statement
6
Very Negative
Balance Sheet
34
Negative
Cash Flow
10
Very Negative
| Breakdown | TTM | Dec 2025 | Dec 2024 | Dec 2023 | Dec 2022 | Dec 2021 |
|---|---|---|---|---|---|---|
Income Statement | ||||||
| Total Revenue | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 |
| Gross Profit | -166.00K | -228.00K | -229.00K | 0.00 | 0.00 | 0.00 |
| EBITDA | -51.43M | -54.65M | -37.42M | -26.73M | -40.33M | -32.90M |
| Net Income | -51.99M | -54.65M | -39.83M | -29.82M | -42.35M | -33.15M |
Balance Sheet | ||||||
| Total Assets | 33.10M | 41.79M | 38.63M | 19.37M | 29.97M | 47.52M |
| Cash, Cash Equivalents and Short-Term Investments | 29.27M | 36.40M | 34.36M | 15.55M | 24.72M | 43.02M |
| Total Debt | 14.95M | 14.96M | 9.96M | 16.73M | 16.20M | 14.99M |
| Total Liabilities | 22.43M | 20.27M | 17.73M | 20.82M | 21.67M | 19.47M |
| Stockholders Equity | 10.68M | 21.52M | 20.90M | -1.45M | 8.30M | 28.04M |
Cash Flow | ||||||
| Free Cash Flow | -45.31M | -49.47M | -29.77M | -24.50M | -37.57M | -29.44M |
| Operating Cash Flow | -45.31M | -49.47M | -29.77M | -24.48M | -37.57M | -29.44M |
| Investing Cash Flow | 9.03M | 6.11M | -21.58M | -21.00K | 0.00 | 0.00 |
| Financing Cash Flow | 51.55M | 51.53M | 48.53M | 15.28M | 19.32M | 36.61M |
Achieve Life Sciences Technical Analysis
Positive
5.10
Price Trends
4.20
Positive
4.42
Positive
4.15
Positive
Market Momentum
0.18
Positive
58.56
Neutral
55.88
Neutral
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 4.99, above the 50-day MA of 4.20, and above the 200-day MA of 4.15, indicating a bullish trend. The MACD of 0.18 indicates Positive momentum. The RSI at 58.56 is Neutral, neither overbought nor oversold. The STOCH value of 55.88 is Neutral, 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 67 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 |
|---|---|---|---|---|---|---|---|
55 Neutral | $537.93M | -5.38 | -193.49% | ― | ― | 16.68% | |
54 Neutral | $232.52M | -2.42 | -30.90% | ― | ― | 10.70% | |
53 Neutral | $163.86M | 10.64 | 35.58% | ― | 93.50% | ― | |
51 Neutral | $7.86B | -0.30 | -43.30% | 2.27% | 22.53% | -2.21% | |
49 Neutral | $176.79M | -2.71 | -339.38% | ― | ― | 17.64% | |
46 Neutral | $259.06M | -5.37 | -80.61% | ― | 43.21% | -15.55% |
* Healthcare Sector Average
ACHV
Achieve Life Sciences
5.24
1.34
34.36%
CLLS
Cellectis SA
3.52
2.03
136.24%
SPRO
Spero Therapeutics
2.83
0.09
3.28%
MIST
Milestone Pharmaceuticals
1.42
-0.31
-17.92%
NKTX
Nkarta
3.25
1.52
87.86%
Achieve Life Sciences Corporate Events
Business Operations and StrategyExecutive/Board ChangesPrivate Placements and Financing
Achieve Life Sciences Adds Director Amid Board Transitions
Neutral
May 12, 2026
On May 11, 2026, Achieve Life Sciences appointed Christopher Martin to its board under a designation right linked to a recent private placement, granting him standard non-employee director compensation, including a pro-rated $40,000 retainer and s...
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.