ACHV · NASDAQ · Biotechnology

Achieve Life Sciences

Develops cytisinicline for nicotine dependence across smoking-cessation and vaping-cessation programs.

$8.26
After-hours close+0.15 (+1.85%)
At close$8.11(−0.86%)
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Profile

Achieve Life Sciences, Inc.ACHVHealth Care

Develops cytisinicline, an investigational treatment for nicotine dependence. Its single operating segment covers development and potential commercialization, with operations in Canada, the United States, and the United Kingdom.

Develops cytisinicline, an investigational treatment for nicotine dependence. Its single operating segment covers development and potential commercialization, with operations in Canada, the United States, and the United Kingdom.

The lead smoking-cessation application received an FDA Complete Response Letter tied to observations at a prior third-party manufacturing facility and unfinished labeling. The company has said it intends to resubmit using Adare Pharma Solutions as primary manufacturer.

A separate vaping-cessation track has completed a Phase 2 study and an end-of-Phase-2 FDA meeting. The business remains dependent on FDA approval of cytisinicline, its only reportable product family.

Company facts

CEOAndrew D. Goldberg, MD
ListedAug 3, 2017
ExchangeNASDAQ
HeadquartersBothell, WA
CountryCanada
Employees28
CIK0000949858
ISINUS0044685008

Key statistics

Market cap$831.5M
EPS (ttm)−$1.55
P/E (ttm)−5.23
ROE-892.1%
P/B−51.61
P/S0.00
Dividend yield
Beta2.03vs XLV 1.02

Year to date +63.2% · Average volume (30d) 1.2M

Analysts

Price target, next 12 months$13.00+60.5%Median of 6 analysts · vs the Aug 28 close
ConsensusBuy6 of 6 analysts rate it buy or better

Ratings

Target range

Latest analyst notes

DateFirmActionRatingPrior targetTarget
Aug 13, 2026Morgan StanleyInitiateOverweight$13
Aug 12, 2026Raymond JamesReiterateStrong Buy$20$18
Aug 12, 2026H.C. WainwrightReiterateBuy$12
Jun 26, 2026Raymond JamesTarget$20
Apr 20, 2026Canaccord GenuityTarget$13

Earnings

EPS

Estimate−$0.20
ReportedDue Nov 5, 2026

Revenue

Estimate$10.6M
ReportedDue Nov 5, 2026

History

Report dateEPS estEPSSurpriseRevenue estRevenueSurpriseNext session
Aug 11, 2026Q2 FY26−$0.16−$0.80−385.2%+1.50%
May 12, 2026Q1 FY26−$0.30−$0.19+36.7%−0.50%
Mar 24, 2026Q4 FY25−$0.27−$0.28−3.7%−2.76%
Nov 6, 2025Q3 FY25−$0.24−$0.28−16.7%−3.16%
View details

Financial highlights

12 quartersQ1 FY25Q2 FY25Q3 FY25Q4 FY25Q1 FY26Q2 FY26
Revenue$0$0$0$0$0$0
Gross profit$0$0−$54.0K$0−$57.0K$0
Operating income−$12.9M−$12.6M−$14.7M−$14.7M−$10.5M−$18.4M
Net income−$12.8M−$12.7M−$14.4M−$14.7M−$10.2M−$74.8M
Diluted EPS−$0.37−$0.37−$0.28−$0.28−$0.19−$0.80
Gross margin
Operating margin

Fiscal years (4-quarter sums)FY21 $0 · FY22 $0 · FY23 $0 · FY24 $0 · FY25 $0

Balance sheet, Jun 30, 2026Cash & short-term investments $187.3M · Total debt $14.9M · Total assets $190.4M · Shareholders' equity −$14.7M

Dividends

No dividends on record.

Ownership

Institutions 20.97%21.52M sharesInsiders 0.89%913.6K sharesOther 78.14%80.22M shares

Shares outstanding 102.66M · Float 87.47M · 85.2% free float

Top shareholders13F · 13D/G · Form 4

HolderShares% outstandingFormFiled
venBio Global Strategic GP V, LLC10.74M9.99%13DApr 27, 2026
Logos Global Management LP10.54M9.99%13GAug 17, 2026
Paradigm BioCapital Advisors LP9.90M9.20%13GApr 24, 2026
TPG GP A, LLC · 10 percent owner6.88M6.70%Form 4Apr 24, 2026
Frazier Life Sciences Public Fund, L.P.6.63M6.50%13GApr 24, 2026

Insider tradesForm 4

DateInsiderRoleSharesAvg price
Aug 19, 2026Richard Alistair Stewartdirector−20,626$8.49
Sep 18, 2025Richard Alistair Stewartdirector, officer: Chief Executive Officer−129,501$2.92
Sep 18, 2025Mark K. Okiofficer: Chief Financial Officer−50,060$2.92
Sep 4, 2025Jaime Xinosofficer: Chief Commercial Officer−20,854$2.77
Sep 4, 2025Cindy Jacobsofficer: President & CMO−27,629$2.77
View details

Peers

CompareAfter-hours close

CompanyPriceChange
Achieve Life Sciences$8.26+1.85%$831.5M
Dr. Reddy's Laboratories (ADR)$12.180.00%$10.15B29.232.53.0−16.2%
Teva (ADR)$36.30−0.36%$42.44B60.712.92.5−0.8%
Pfizer$27.95−0.04%$159.36B36.910.02.5+2.6%
Median36.912.92.5−0.8%