# Achieve Life Sciences, Inc. (ACHV)

> Source: Nexqual · https://nexqual.com/ACHV · data as of 2026-10-28 20:00 UTC · cite as "Nexqual, Achieve Life Sciences, Inc. (ACHV), nexqual.com/ACHV" · informational, not investment advice.

**Price:** USD 6.85 (-1.15% on the day) · last close of Oct 28, 2026; US market closed, not a live price. Prev close 6.93 · day 6.68–6.97 · 52w 2.62–8.64 · market cap $706M · NCM

## Key facts
- Insider open-market sales, last ~7 months: 1 Form 4 filings, $175K; 1 not under a Rule 10b5-1 plan ($175K); 0 by opportunistic insiders, 0 by routine insiders (three-year test, Cohen, Malloy & Pomorski 2012).
- Analysts: Buy (mean 1.75 on a 1–5 scale) (12 analysts), mean target USD 14.15 (range 9–21).
- Total return with dividends: 1Y +40.0% vs S&P 500 +13.2%; 5Y -17.4% vs S&P 500 +79.8%.
- Next earnings: 2026-11-05, EPS estimate USD -0.19, revenue estimate $0K.

## Financials (SEC 10-K; TTM = last four 10-Q/10-K quarters)
| USD | FY2021 | FY2022 | FY2023 | FY2024 | FY2025 | TTM |
|---|---|---|---|---|---|---|
| Net income | -$33.2M | -$42.4M | -$29.8M | -$39.8M | -$54.6M | -$114M |
| EPS (diluted) | -$4.08 | -$4.00 | -$1.50 | -$1.24 | -$1.25 | — |
| Free cash flow | — | — | -$24.5M | — | -$49.5M | — |
| Cash + short-term investments | $43.0M | $24.8M | $15.5M | $34.4M | $36.4M | — |
| Total debt | $14.9M | — | — | $9.8M | $11.2M | — |
Fiscal years end Dec. EPS is split-adjusted.

## Valuation (price ÷ last four quarters, through Jun 30, 2026)
Earnings yield -16.15% · Net cash $180M · EV $526M

## Insider sales (SEC Form 4, open-market, last ~7 months)
0 of 1 under a Rule 10b5-1 trading plan (scheduled in advance). Unplanned sales were timed by the insider.
| Trade date | Insider | Role | Shares | Value | % of holdings sold | 10b5-1 plan | Insider type |
|---|---|---|---|---|---|---|---|
| 2026-08-19 | Stewart Richard Alistair | Director | 20,626 | $175K | 9% | No | Too little history (no open-market trades in 2023) |
% of holdings sold = shares sold ÷ (shares sold + all holdings the insider reported on that Form 4, direct and through trusts).
Insider type follows Cohen, Malloy & Pomorski (Journal of Finance, 2012). An insider who traded the stock in the same calendar month in each of the past three years is a routine trader; one who traded in each of those years without such a pattern is an opportunistic trader. In their study, trades by opportunistic insiders predicted future returns and trades by routine insiders did not. Counts open-market purchases and sales only (SEC Form 4 codes P and S) by that insider in that company. Not investment advice.

## Analysts
Consensus Buy (mean 1.75 on a 1–5 scale), 12 analysts; mean target USD 14.15 (low 9, high 21).
Rating changes, last 120 days:
| Date | Firm | Action | Rating | Price target |
|---|---|---|---|---|
| 2026-09-30 | Stifel | Initiated | Buy | $18 |
| 2026-08-13 | Morgan Stanley | Initiated | Overweight | $13 |

## Total return (dividends reinvested)
|  | 1Y (from 2025-10-29) | 5Y (from 2021-10-25) |
|---|---|---|
| Total return | +40.0% | -17.4% |
| S&P 500 (SPY) | +13.2% | +79.8% |
| Per year | +40.3% | -3.7% |
| Volatility (annualized) | 80.8% | 77.9% |
| Max drawdown | -54.5% (Jan 2026→Mar 2026) | -77.2% (May 2023→Apr 2025) |

## Peers (Biotechnology)
ORKA (Oruka Therapeutics, Inc.) USD 95.97 +0.17% · LGND (Ligand Pharmaceuticals Incorpor) USD 318.78 +2.26% · IOVA (Iovance Biotherapeutics, Inc.) USD 14.81 +1.58% · IONS (Ionis Pharmaceuticals, Inc.) USD 44.9 +2.14% · AXSM (Axsome Therapeutics, Inc.) USD 143.51 +0.92% · ABVX (Abivax SA) USD 89.84 +3.26%

## More
Full page: https://nexqual.com/ACHV · Free keyless MCP server with the same data and citations: https://mcp.nexqual.com/mcp · Guide for agents: https://nexqual.com/agents · https://nexqual.com/llms.txt

## Company outlook (8-K filed 2026-08-11)

- "Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for cytisinicline, an outcome the Company disclosed it anticipated in April 2026."
- "The Company intends to resubmit its NDA naming Adare as its finished drug product manufacturer for commercial supply in the fourth quarter of 2026 and anticipates potential FDA approval in the first half of 2027, with U.S. commercial launch to follow."
- "Scientific Data Advancement • Presented 52-week safety data from the ORCA-OL study at the American Thoracic Society (ATS) 2026 Annual Meeting, completing the anticipated clinical evidence package supporting the cytisinicline NDA."
- "Proceeds are expected to fund the ORCA-V2 Phase 3 trial, the commercialization of cytisinicline, and working capital and general corporate purposes."

## Analyst estimates and revisions

| Period | EPS est. | 90d ago | Change | Revenue est. | Analysts |
|---|---|---|---|---|---|
| Current quarter (ends 2026-09-30) | $-0.19 | $-0.16 | −$0.03 | $0 | 12 |
| Next quarter (ends 2026-12-31) | $-0.20 | $-0.19 | −$0.01 | $0 | 12 |
| Current fiscal year (ends 2026-12-31) | $-1.38 | $-0.68 | −$0.70 | $0 | 11 |
| Next fiscal year (ends 2027-12-31) | $-0.65 | $-0.49 | −$0.16 | $38.0M | 12 |

## Earnings history and stock reaction
| Results filed | Quarter | EPS | Consensus | Surprise | Stock reaction |
|---|---|---|---|---|---|
| — | Quarter ended Jun 30, 2026 | −$0.80 | −$0.16 | Miss −400.0% | — |
| — | Quarter ended Mar 31, 2026 | −$0.19 | −$0.30 | Beat +36.7% | — |
| — | Quarter ended Dec 31, 2025 | −$0.28 | −$0.28 | In line | — |
| — | Quarter ended Sep 30, 2025 | −$0.28 | −$0.26 | Miss −7.7% | — |
EPS as reported against the analyst consensus before the release; surprise uses the cent-rounded figures shown (in dollars when EPS and consensus have opposite signs). Stock reaction = close before the results to close after (the first close following a release after the bell or before the open).

## Recent SEC filings (last 120 days)
| Filed | Form | What it says | Filing |
|---|---|---|---|
| 2026-10-01 | 8-K | Director or executive officer change, or pay arrangement — “On October 1, 2026, Achieve Life Sciences, Inc. (the " Company ") announced that the Board of Directors of the Company (the " Board ") appointed Benjamin Halladay as the Company's Chief Financial Officer and "principal financial officer," effective as of October 5, 2026 (the " Appointment Date "). Before joining the Company, Mr. Halladay, age 40, served in several different roles at Esperion Therapeutics, Inc., a pharmaceutical company, including as Chief Financial Officer from November 2022 until September 2026,…” | https://www.sec.gov/Archives/edgar/data/949858/000119312526410781/0001193125-26-410781-index.htm |
| 2026-08-17 | Schedule 13G | Logos Global Management LP, Logos Global Management GP LLC: 10.0% of shares, passive 5%+ holder | https://www.sec.gov/Archives/edgar/data/949858/000093583626000426/0000935836-26-000426-index.htm |
| 2026-08-14 | 8-K | Other material event — “On August 14, 2026, Achieve Life Sciences, Inc. (the "Company") entered into an Open Market Sale Agreement SM (the "Sales Agreement") with Jefferies LLC ("Jefferies"), under which the Company may offer and sell, from time to time at its sole discretion, shares of its common stock, par value $0.001 per share ("Common Stock"), having an aggregate offering price of up to $150.0 million (the "ATM Shares"), through Jefferies, as sales agent, pursuant to an at-the-market offering program (the "ATM Program"). The ATM…” | https://www.sec.gov/Archives/edgar/data/949858/000119312526352229/0001193125-26-352229-index.htm |
| 2026-08-13 | Schedule 13G | JANUS HENDERSON GROUP Ltd.: 5.4% of shares, passive 5%+ holder | https://www.sec.gov/Archives/edgar/data/949858/000127417326000193/0001274173-26-000193-index.htm |
| 2026-08-11 | 10-Q | Quarterly report · period ended Jun 30, 2026 | https://www.sec.gov/Archives/edgar/data/949858/000119312526344624/0001193125-26-344624-index.htm |
| 2026-08-11 | 8-K | Quarterly results | https://www.sec.gov/Archives/edgar/data/949858/000119312526344571/0001193125-26-344571-index.htm |
| 2026-07-28 | Schedule 13G/A | Franklin Resources, Inc., Charles B. Johnson: 8.3% of shares, passive 5%+ holder (amended) | https://www.sec.gov/Archives/edgar/data/949858/000003877726000201/0000038777-26-000201-index.htm |
| 2026-07-27 | Schedule 13G | BlackRock, Inc.: 5.1% of shares, passive 5%+ holder | https://www.sec.gov/Archives/edgar/data/949858/000201238326002256/0002012383-26-002256-index.htm |
| 2026-07-08 | Schedule 13G | Vivo Opportunity Fund Holdings, L.P., Vivo Opportunity Co-Invest, L.P.: 5.0% of shares, passive 5%+ holder | https://www.sec.gov/Archives/edgar/data/949858/000121390026076390/0001213900-26-076390-index.htm |
| 2026-07-06 | 8-K | Bylaws or fiscal-year change; Shareholder vote results | https://www.sec.gov/Archives/edgar/data/949858/000119312526296174/0001193125-26-296174-index.htm |
Source: SEC EDGAR. Quotes are the opening words of each item as filed.