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Achieve Life Sciences

ACHV

Market cap $753M

7.32 USD

+0.09

1.24%

At close Updated Sep 15, 4:00 PM EDT

Pre-market

After hours

7.18

-0.14

1.91%

1 day

1.24%

5 days

-6.39%

1 month

-2.4%

3 months

30.71%

6 months

74.29%

Year to date

47.28%

1 year

140.79%

5 years

-9.96%

10 years

-99.35%

About: Achieve Life Sciences Inc is a late-stage clinical specialty pharmaceutical company with the sole mission to address the nicotine dependence epidemic through the development and commercialization of cytisinicline. Cytisinicline, is a naturally occurring alkaloid. Additionally, The company has completed a Phase 2 study with cytisinicline in vaping cessation and conducted a successful end-of-Phase 2 meeting with the FDA for a future vaping indication. It operates in one operating segment, development and commercialization of cytisinicline for nicotine dependence, with operations located in Canada, the United States and the U.K.

Employees: 28

Healthcare Biotechnology

News

Positive

Neutral

Negative

Sentiment 3-Months

Positive 18.2%

Neutral 63.6%

Negative 18.2%

Achieve Life Sciences Announced Granting of New Hire Inducement Awards

SEATTLE and VANCOUVER, British Columbia, Sept. 03, 2026 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage specialty pharmaceutical company focused on the global development and commercialization of cytisinicline as a treatment for nicotine dependence, today announced that Achieve's board of directors approved stock option grants to purchase an aggregate of 315,000 shares of its common stock and restricted stock unit (“RSU”) awards covering an aggregate of 283,000 shares of its common stock for 7 new employees under Achieve's 2024 Equity Inducement Plan.

Achieve Life Sciences Announced Granting of New Hire Inducement Awards

Achieve Life Sciences Appoints Ronald Dadino and Gloria Cosgrove to Lead CMC, Supply Chain, and Quality

SEATTLE and VANCOUVER, British Columbia, Aug. 03, 2026 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Achieve or the Company) (Nasdaq: ACHV), a late-stage specialty pharmaceutical company focused on the global development and commercialization of cytisinicline as a treatment for nicotine dependence, today announced the appointments of Ronald Dadino as Senior Vice President, Chemistry, Manufacturing and Controls (CMC) and Supply Chain, and Gloria Cosgrove as Senior Vice President, Quality. Both executives bring decades of leadership across pharmaceutical manufacturing, supply chain, and quality.

Achieve Life Sciences Appoints Ronald Dadino and Gloria Cosgrove to Lead CMC, Supply Chain, and Quality

Achieve Life Sciences Announced Granting of New Hire Inducement Awards

SEATTLE and VANCOUVER, British Columbia, July 31, 2026 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage specialty pharmaceutical company focused on the global development and commercialization of cytisinicline as a treatment for nicotine dependence, today announced that Achieve's board of directors approved stock option grants to purchase an aggregate of 1,190,000 shares of its common stock and restricted stock unit (“RSU”) awards covering an aggregate of 125,000 shares of its common stock for six new employees under Achieve's 2024 Equity Inducement Plan. The stock options have an exercise price equal to the closing price of Achieve's common stock on the grant date.

Achieve Life Sciences Announced Granting of New Hire Inducement Awards

Achieve Life Sciences Stockholders Weigh Board Slate, Share Increase at Annual Meeting

Achieve Life Sciences NASDAQ: ACHV held its 2026 Annual Meeting of Stockholders virtually, with Chief Executive Officer Andrew Goldberg serving as chairperson of the meeting. Goldberg called the meeting to order and said Erik Atkisson, the company's Chief Legal Officer, would act as secretary and record the minutes.

Achieve Life Sciences Stockholders Weigh Board Slate, Share Increase at Annual Meeting

Achieve Life Sciences: Despite CRL, A Success Is Achieve-Able

The last months were eventful for Achieve Life Sciences, sending the stock strongly down, but later to a new high for the year, implying optimism about the future path. Achieve is, in my view, a more derisked case now, thanks to successful financing, progress on shifting its supply chain, and new leadership. Despite the CRL, ACHV continues to advance. The denial was not drug-related, pointing towards a possible successful outcome in this story.

Achieve Life Sciences: Despite CRL, A Success Is Achieve-Able

Achieve Life Sciences Joins Russell 2000® Index

SEATTLE and VANCOUVER, British Columbia, June 29, 2026 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Achieve or the Company) (Nasdaq: ACHV), a late-stage specialty pharmaceutical company focused on the global development and commercialization of cytisinicline as a treatment for nicotine dependence, today announced that it has been added to the Russell 2000® Index, effective June 26, 2026, as part of the Russell U.S. Indexes reconstitution. The Company is also a member of the Russell 3000® Index.

Achieve Life Sciences Joins Russell 2000® Index

Achieve Life Sciences: CRL Is Fixable, So I Remain Bullish

Achieve Life Sciences remains a cytisinicline story, with very positive smoking-cessation data. This also gives cytisinicline some added optionality for vaping. The FDA's CRL appears to be mostly about manufacturing and labeling issues. However, it's not about a particular cytisinicline efficacy or safety problem. ACHV is currently targeting Q4 2026 resubmission and, assuming everything goes according to plan, it could receive approval by 1H2027.

Achieve Life Sciences: CRL Is Fixable, So I Remain Bullish

FDA Declines To Approve Achieve Life Sciences' Smoking Cessation Drug; Q4 Resubmission Planned

Achieve Life Sciences Inc. (NASDAQ:ACHV) on Monday received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for its New Drug Application seeking approval of cytisinicline, its investigational treatment for nicotine dependence.

FDA Declines To Approve Achieve Life Sciences' Smoking Cessation Drug; Q4 Resubmission Planned

US FDA declines to approve Achieve Life Sciences' smoking-cessation drug

The U.S. Food and Drug Administration has declined to approve Achieve Life ‌Sciences' drug to treat nicotine dependence in adults, the company said on Monday.

US FDA declines to approve Achieve Life Sciences' smoking-cessation drug

Achieve Life Sciences Receives Complete Response Letter from FDA for Cytisinicline NDA

CRL Cites Deficiencies at Third-Party Manufacturing Facility No Efficacy or Clinical Safety Deficiencies Identified SEATTLE and VANCOUVER, British Columbia, June 22, 2026 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Achieve or the Company) (Nasdaq: ACHV), a late-stage specialty pharmaceutical company focused on the global development and commercialization of cytisinicline as a treatment of nicotine dependence, today announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for cytisinicline. The CRL relates to outstanding manufacturing-related observations from a current Good Manufacturing Practice (cGMP) inspection of a third-party manufacturing facility and to final product labeling that was not completed by the FDA's action date.

Achieve Life Sciences Receives Complete Response Letter from FDA for Cytisinicline NDA

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