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Achieve Life Sciences/$ACHV

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About Achieve Life Sciences

Achieve Life Sciences Inc is a late-stage specialty pharmaceutical company focused on the world-wide development and commercialization of cytisinicline as a treatment for nicotine dependence. Its New Drug Application (NDA) for cytisinicline for smoking cessation in adults is supported by two completed Phase 3 studies and an open-label long-term safety study. It has also completed a Phase 2 study of cytisinicline in nicotine e-cigarette cessation, conducted an end-of-Phase 2 meeting with the FDA, and has received Breakthrough Therapy designation for the vaping cessation indication.
Ticker
$ACHV
Sector
Health
Primary listing
NASDAQ
Employees
28

ACHV Metrics

BasicAdvanced
$656M
-
-$1.81
2.25
-

What the Analysts think about ACHV

Analyst ratings (Buy, Hold, Sell) for Achieve Life Sciences stock.
Analyst projections of the future price of Achieve Life Sciences stock.

Bulls say / Bears say

The FDA’s refusal was tied to manufacturing compliance and unfinished labelling, not reported efficacy or clinical-safety deficiencies. Achieve has moved production to Adare and says it plans to resubmit in the fourth quarter of 2026. (Reuters, Achieve Life Sciences)
In a year-long study of people who had already failed a supported quit attempt, 31.2% achieved four-week sustained abstinence in the final four weeks of treatment. The study found no new safety signals, adding supportive evidence for longer treatment. (Achieve Life Sciences)
The $180 million upfront private placement and $187.3 million of cash, equivalents and marketable securities at June 2026 give Achieve substantial resources for the regulatory work and launch preparations. It has also transferred testing methods to Adare and made an engineering batch there. (Achieve Life Sciences)
The FDA did not approve cytisinicline on the original review timetable, delaying a potential launch while Achieve addresses manufacturing and labelling issues. The company is targeting approval only in the first half of 2027, and that timetable depends on a successful resubmission. (Reuters, Achieve Life Sciences)
Existing shareholders face dilution risk: Achieve has authority to sell up to $150 million of stock through an at-the-market programme, alongside a large warrant overhang. The warrants and any further fundraising could increase the share count materially. (SEC, SEC)
Achieve has no approved products or sales revenue and relies on cytisinicline as its sole product candidate. Its filing also flags dependence on third-party manufacturing and limited plant-source supply, as well as an ongoing dispute with supplier Sopharma. (SEC)
Data summarised monthly by Lightyear AI. Last updated on 2 Nov 2026.

ACHV Financial Performance

Revenues and expenses
Income statement
QuarterlyAnnual
Q3 24
QoQ growth
Revenue
Net income
Profit margin

ACHV Earnings Performance

Company profitability
Earnings per share
QuarterlyAnnual
Q4 23
Q1 24
Q2 24
Q3 24
Q4 24
Actual
Expected
Surprise

Funds containing ACHV

Funds
Fund name
Fund size
$ACHV weighting
SPDR Russell 2000 US Small Cap€R2US
$5.3B0.02%
SPDR Russell 2000 US Small Cap£R2SC
$5.3B0.02%
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