Last updated
Revenue
R&D Expenses
Operating CF
Total Assets
Total Liabilities
Equity
Shares Out.
D/E Ratio
Dilution Watch
Financials
52W LOW $2.6252W HIGH $8.64
Volume
383.36 K
Value Traded
5.97 M
Short % Float
22.91%
+1.52%Week
-2.52%1 Month
+20.29%3 Month
+110.6%6 Month
-49.3%5 Year
-100%All Time
Cash Data
- Monthly Burn
- Burn Trend
- Dilution Risk
- SEC Filing
Key Stats
Market Cap
753.25 M
EPS (TTM)
-1.53
P/E Ratio
-
Ent. Value
565.94 M
Total Shares
102.85 M
Float Shares
69.81 M
Insiders
32.16%
Institutions
56.41%
Upcoming Catalysts
FDA decisions, readouts and PDUFA dates · scored by probability of approval
ACHV Catalyst Timeline
Dated clinical, regulatory and corporate events for Achieve Life Sciences, Inc.
Catalyst Timeline
Dated clinical, regulatory & corporate events for Achieve Life Sciences, Inc.
490Total events
9Upcoming
98Tier-1 (high impact)
2008 to 2027Coverage
Upcoming catalysts 2
Event history 50
●Management ChangeCorporate
Kaitlyn Tuson appointed Senior Vice President, Marketing and Communications
●Management ChangeCorporate
Benjamin Halladay appointed Chief Financial Officer; board approves inducement awards
▲Manufacturing MilestoneCytisiniclineFiledCMC / Inspection
Completed analytical method technology transfer and first engineering batch at Adare
▼Complete Response LetterCytisiniclineFiledFDA Decision
FDA issued Complete Response Letter for cytisinicline NDA due to manufacturing facility deficiencies
nicotine dependence (smoking cessation)source ↗
◆PDUFA DateCytisiniclineFiledRegulatory Filing
PDUFA target action date of June 20, 2026 for smoking cessation NDA
nicotine dependence for smoking cessationsource ↗
▼Complete Response LetterCytisiniclineFiledFDA Decision
FDA issued Complete Response Letter for cytisinicline NDA
smoking cessationsource ↗
▲Management ChangeCorporate
Appointment of Jeffrey Farrow and Reid Waldman, MD to Board of Directors
●Manufacturing MilestoneCytisiniclineFiledCMC / Inspection
Advances U.S.-based manufacturing transition and partnership with Adare Pharma Solutions
nicotine dependencesource ↗
●Oral PresentationCytisiniclineFiledPresentation
Long-term safety data presented at ATS International Conference
nicotine dependence (smoking cessation)source ↗
▼Equity OfferingCorporate
Closed private placement of up to $354 million, including $180 million upfront and $174 million in milestone-driven warrants
▲PublicationCytisiniclineFiledPresentation
Publication in Nicotine & Tobacco Research on cytisinicline receptor selectivity
nicotine dependencesource ↗
▲Oral PresentationCytisiniclineFiledPresentation
Oral presentation on cytisinicline efficacy by prior treatment history and quit attempts
smoking cessationsource ↗
▲Poster PresentationCytisiniclineFiledPresentation
Poster presentation on participant experience survey from ORCA-OL
smoking cessationsource ↗
▲Oral PresentationCytisiniclineFiledPresentation
Late-breaking voluntary survey data from ORCA-OL presented at SRNT 2026 Annual Meeting
nicotine dependencesource ↗
▲Oral PresentationCytisiniclineFiledPresentation
Presented analysis of ORCA-2 and ORCA-3 in cancer history patients at ASCO 2026
smoking cessationsource ↗
◆Safety Data UpdateCytisiniclineFiledClinical Data
120-Day Safety Update Submitted to FDA
smoking cessationsource ↗
▲Trial CompletionCytisiniclineFiledTrial
ORCA-OL Long-Term Safety Trial Successfully Concluded
smoking cessationsource ↗
▲DSMB ReviewCytisiniclineFiledTrial
DSMC Completes Final Review of Cytisinicline, Finds No Drug Safety Concerns
smoking cessationsource ↗
▲DSMB ReviewCytisiniclineFiledTrial
Fourth and final scheduled DSMC safety review for ORCA-OL completed
nicotine dependence for smoking cessationsource ↗
▲FDA Feedback ReceivedCytisiniclineFiledFDA Meeting
FDA grants Breakthrough Therapy designation for cytisinicline for vaping cessation
nicotine dependence for e-cigarette or vaping cessationsource ↗
▲Topline ReadoutCytisiniclineFiledClinical Data
Phase 2 ORCA-V1 topline results published in JAMA Internal Medicine
nicotine dependence for e-cigarette or vaping cessationsource ↗
▲End Of Phase 2 MeetingCytisiniclineFiledFDA Meeting
Successful end-of-Phase 2 meeting with FDA for vaping indication
nicotine dependence for e-cigarette or vaping cessationsource ↗
▲Other Regulator MilestoneCytisiniclineFiledEx-US Regulatory
FDA awards Commissioner's National Priority Voucher (CNPV) for cytisinicline
nicotine dependence for e-cigarette or vaping cessationsource ↗
▲PublicationCytisiniclineFiledPresentation
Publication in Thorax of post hoc analysis of ORCA-2 and ORCA-3 trials showing cytisinicline efficacy and tolerability in COPD smokers
smoking cessation in COPDsource ↗
▲FDA Filing AcceptedCytisiniclineFiledRegulatory Filing
FDA accepted cytisinicline NDA
nicotine dependence for smoking cessationsource ↗
▲Trial CompletionCytisiniclineFiledTrial
Completed Phase 2 study in vaping cessation
vaping cessationsource ↗
▲End Of Phase 2 MeetingCytisiniclineFiledFDA Meeting
Successful end-of-Phase 2 meeting with FDA for vaping indication
vaping cessationsource ↗
▲FDA Filing AcceptedCytisiniclineFiledRegulatory Filing
FDA accepted cytisinicline NDA for smoking cessation
nicotine dependence for smoking cessationsource ↗
▲FDA Filing AcceptedCytisiniclineFiledRegulatory Filing
FDA accepted NDA for cytisinicline for smoking cessation
nicotine dependence for smoking cessationsource ↗
▲Trial CompletionCytisiniclineFiledTrial
Completed Phase 2 study in vaping cessation
vaping cessationsource ↗
▲End Of Phase 2 MeetingCytisiniclineFiledFDA Meeting
Successful end-of-Phase 2 meeting with FDA for vaping cessation
vaping cessationsource ↗
Past FDA Catalysts and PDUFA Decisions
How ACHV actually traded into and out of each decision
| Date | Drug | Catalyst | Stage | Reaction | Event Move % | Best Trade % |
|---|---|---|---|---|---|---|
| 2026-06-22 | Cytisinicline | PDUFA Date CRL | PDUFA |
Reaction: 30 trading days around the event · Event Move: close to close on decision day · Best Trade: peak run-up from entry 10 days before the decision
Drug Pipeline Intelligence
C53 / 100
Pipeline Score
$701M
Pipeline Value
Fair Value
Valuation Signal
4
Drugs Scored
1.0x
rNPV / MCap
Top 12%
Micro Cap(rank 80 of 658)
Percentile Rank
Achieve Life Sciences, Inc. carries a moderate pipeline score (53/100), with $1.8B risk-adjusted pipeline value, led by Custirsen, paclitaxel and carboplatin in Non-small Cell Lung Cancer (Phase 3), across $56B in total addressable markets.
| Drug | Indication | Phase | PTRS | rNPV | Status | Enroll | Velocity | Design | Est. Completion | ML Signal | Last Change |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Custirsen, paclitaxel and carboplatin RNA therapyCompletedNCT00138658 | Non-small Cell Lung Cancer | Phase 3 | COMPLETED | 749 | Mar 1, 2010 |
Clinical Trial Results
Readouts, endpoints and source filings for every ACHV program
| Drug Name | Indication | Phase | Date | Trial Results Summary | Title | Source |
|---|---|---|---|---|---|---|
| cytisinicline Breakthrough | smoking cessation | Phase 3 | 2026-03-04 | 6 and 12 weeks of cytisinicline delivers meaningful quitting success, regardless of participants' prior use of smoking cessation medications or number of previous quit attempts.Read More | Achieve Life Sciences Presents Data at SRNT Demonstrating Successful Cessation in Smokers with Extensive Prior Treatment Exposure; and on Participant Experience in the ORCA-OL StudyRead More |
Inside Trades
| Insider | Side | Shares | Price | Value | Date |
|---|---|---|---|---|---|
| Stewart Richard AlistairDirector | Sell | -20,626 208,249 held | $8.49 | 08/19/2026 |
Hedge Fund 13F Activity
Hedge Funds invested in ACHV
| Fund | % of Portfolio | Current MV | Shares Owned | Activity |
|---|---|---|---|---|
| Frazier Life Sciences Management, L.P. | 1.1 % | 49.72 M | 7.61 M |
ACHV Institutional Ownership Trends
Options Data
Option Volume
Open Interest
Call OI
Put OI
Put-Call Ratio
OI 30-day avg
Today vs avg
Option Volume
Call Vol
Put Vol
Put-Call Ratio
Vol 30-day avg
Today vs avg
Option Chain Statistics
| Expiry | Call Vol | Put Vol | Vol P/C | Call OI | Put OI | OI P/C | IV Call | IV Call OI-Wtd | IV Call Vol-Wtd | IV Put | IV Put OI-Wtd | IV Put Vol-Wtd |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2026-11-20 | ||||||||||||
Real-Time Option Chain
| Calls | Strike | Puts | ||||
|---|---|---|---|---|---|---|
| Last | Vol | OI | Last | Vol | OI | |
| No data available | ||||||
Calls vs Puts by Expiry
CallsPutsLog scale
Competitive positioning
How ACHV ranks across every disease it competes in
Competitive Position is a premium feature
See how ACHV ranks against every competitor across each disease it develops in: phase, best drug, trials and likelihood of approval.
Start free trialACHV News
ACHV▲ +1.8%today
Achieve Life Sciences Appoints Kaitlyn Tuson as Senior Vice President, Marketing and Communications
Achieve Life Sciences has appointed Kaitlyn Tuson as Senior Vice President of Marketing and Communications. Tuson brings 15 years of experience in healthcare branding and will lead efforts to prepare for the commercialization of cytisinicline, a treatment for nicotine dependence. This appointment is part of Achieve's broader strategy to advance its New Drug Application resubmission and enhance patient engagement.
Read more →ACHV▲ +1.8%today
Achieve Life Sciences Announces Granting of New Hire Inducement Awards
Achieve Life Sciences has announced the granting of stock options and RSU awards to new employees, including its new CFO, Benjamin Halladay. The stock options and RSUs are part of the company's 2024 Equity Inducement Plan, aimed at incentivizing new hires. Achieve continues to advance its development of cytisinicline, a treatment for nicotine dependence, supported by successful clinical studies.
Read more →ACHV▼ -6.9%on this newsshared move
Achieve Life Sciences Appoints Benjamin Halladay as Chief Financial Officer
Achieve Life Sciences has appointed Benjamin Halladay as Chief Financial Officer, effective October 5, 2026. Halladay, who previously served as CFO at Esperion Therapeutics, will oversee Achieve's financial strategy and operations as the company prepares for the commercialization of cytisinicline, a treatment for nicotine dependence. His extensive experience in the pharmaceutical sector is expected to support Achieve's goals.
Read more →ACHVAchieve Life Sciences to Present 52-Week Cytisinicline Efficacy Data for Smoking and E-Cigarette Cessation at CHEST 2026
Achieve Life Sciences will present new data on the efficacy of cytisinicline for smoking and e-cigarette cessation at CHEST 2026. The study, involving 475 participants, evaluated the treatment's effectiveness over 52 weeks. The presentation is scheduled for October 20, 2026, and highlights the urgent need for effective cessation aids.
Read more →ACHVAchieve Life Sciences Announced Granting of New Hire Inducement Awards
Achieve Life Sciences has announced the approval of stock option grants and RSU awards for seven new employees as part of its 2024 Equity Inducement Plan. The stock options will vest over four years, encouraging long-term commitment from new hires. This move reflects Achieve's growth strategy as it continues to focus on the development of cytisinicline for nicotine dependence.
Read more →ACHVAchieve Life Sciences Reports Second Quarter 2026 Financial Results and Provides Business Updates
Achieve Life Sciences reported its second quarter 2026 financial results, highlighting a successful private placement of up to $354 million and the strengthening of its leadership team. The company anticipates FDA approval for cytisinicline in early 2027, following a Complete Response Letter that raised no concerns about the drug's efficacy or safety. Achieve is focused on resubmitting its New Drug Application and preparing for commercial launch.
Read more →ACHVAchieve Life Sciences Appoints Ronald Dadino and Gloria Cosgrove to Lead CMC, Supply Chain, and Quality
Achieve Life Sciences has appointed Ronald Dadino and Gloria Cosgrove as Senior Vice Presidents for CMC, Supply Chain, and Quality. Their extensive experience in pharmaceutical manufacturing and quality assurance is expected to bolster Achieve's operations as it prepares for the resubmission of its New Drug Application for cytisinicline. The company aims to ensure rigorous control and reliability in delivering its nicotine dependence treatment.
Read more →ACHVAchieve Life Sciences Joins Russell 2000® Index
Achieve Life Sciences has been added to the Russell 2000 Index as of June 26, 2026. This inclusion is significant as the Russell 2000 Index is a key benchmark for small-cap U.S. equities, potentially increasing the company's visibility among institutional investors. Achieve focuses on developing cytisinicline for nicotine dependence, supported by successful clinical studies.
Read more →ACHV▲ +5.2%on this news· ran to +18% by day 3
Achieve Life Sciences Receives Complete Response Letter from FDA for Cytisinicline NDA
Achieve Life Sciences received a Complete Response Letter from the FDA for its cytisinicline NDA, citing manufacturing deficiencies but no safety or efficacy issues. The company plans to resubmit its application in Q4 2026 after addressing these concerns. Cytisinicline has shown promising results in clinical trials for smoking cessation.
Read more →ACHV▼ -5.1%on this news
Achieve Life Sciences Appoints Jeffrey Farrow and Reid Waldman, MD to Board of Directors
Achieve Life Sciences has appointed Jeffrey Farrow and Dr. Reid Waldman to its Board of Directors as the company prepares for the NDA resubmission of cytisinicline, a treatment for nicotine dependence. Both appointees bring extensive experience in biotech and pharmaceutical launches, which is crucial as Achieve aims to deliver a new smoking cessation therapy. The company is positioned at a pivotal moment with promising clinical data supporting cytisinicline's efficacy.
Read more →ACHVAchieve Life Sciences Presents Safety Data from 52 Weeks of Continuous Cytisinicline Treatment
Achieve Life Sciences presented long-term safety data for cytisinicline at the ATS 2026 Annual Meeting. The ORCA-OL study involved 475 adults and demonstrated a favorable safety profile over 52 weeks. Despite some adverse events, the majority were mild. The findings support the company's New Drug Application for cytisinicline as a treatment for nicotine dependence.
Read more →ACHV▲ +7.2%on this news
Achieve Life Sciences Strengthens Board and Commercial Leadership with Three Senior Appointments from Team Previously at Verona Pharma
Achieve Life Sciences has announced three senior leadership appointments, including Christopher Martin to the Board and Mark Zappia and Jim Willis to key commercial roles. These appointments follow the recent appointment of Dr. Andrew D. Goldberg as CEO and a significant financing round. The company aims to commercialize cytisinicline, a potential new treatment for nicotine dependence, as it prepares for FDA approval.
Read more →ACHV▲ +7.2%on this newsshared move
Achieve Life Sciences Reports First Quarter 2026 Financial Results and Provides Business Updates
Achieve Life Sciences reported its first quarter 2026 financial results, highlighting significant advancements in its development of cytisinicline for nicotine dependence. The company secured up to $354 million in financing to support its Phase 3 trial for e-cigarette cessation and announced leadership changes. Achieve anticipates resubmitting its New Drug Application by Q4 2026, aiming for a U.S. commercial launch in early 2027.
Read more →ACHVAchieve Life Sciences to Announce First Quarter 2026 Financial Results and Host Conference Call and Webcast on May 12, 2026
Achieve Life Sciences will announce its first quarter 2026 financial results on May 12, 2026, along with a corporate update. The company is focused on the development of cytisinicline for nicotine dependence, with an FDA review underway for its New Drug Application submitted in June 2025. The FDA has set a PDUFA date of June 20, 2026.
Read more →ACHV▲ +35.5%on this news
Achieve Life Sciences Announces Up to $354 Million Private Placement
Achieve Life Sciences has announced a private placement agreement to raise up to $354 million, aimed at funding a Phase 3 clinical trial for cytisinicline, a treatment for nicotine dependence. The placement involves new and existing investors and will close on April 17, 2026. Additionally, Dr. Andrew D. Goldberg has been appointed as the new CEO, bringing extensive healthcare expertise.
Read more →ACHV▲ +35.5%on this newsshared move
Achieve Life Sciences Announces Appointment of Andrew D. Goldberg, MD, as Chief Executive Officer and to the Board of Directors
Achieve Life Sciences has appointed Dr. Andrew D. Goldberg as its new CEO and Board member, effective after a recent financing. Dr. Goldberg brings a wealth of experience in medicine and business, aiming to enhance operational excellence and shareholder value. The company is focused on advancing cytisinicline, a treatment for nicotine dependence, towards FDA approval.
Read more →ACHVAchieve Life Sciences Announces Operational Progress Including Completion of Technology Transfer to Adare Pharma Solutions
Achieve Life Sciences has made significant operational progress by completing the technology transfer of cytisinicline manufacturing to Adare Pharma Solutions. The first engineering batch has been successfully produced, positioning the company for future commercial production. However, Achieve faces challenges with an FDA classification indicating compliance issues at a third-party facility, which may affect its regulatory timeline.
Read more →About Achieve Life Sciences, Inc.
Headquarters22722 29TH DR. SE, SEATTLE, WA, 98021
Founded1991
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