Welcome to our dedicated page for Achieve Life Sciences SEC filings (Ticker: ACHV), a comprehensive resource for investors and traders seeking official regulatory documents including 10-K annual reports, 10-Q quarterly earnings, 8-K material events, and insider trading forms.
The Achieve Life Sciences, Inc. (Nasdaq: ACHV) SEC filings page brings together the company’s regulatory documents as filed with the U.S. Securities and Exchange Commission. Achieve describes itself as a late-stage specialty pharmaceutical company focused on developing and commercializing cytisinicline as a treatment of nicotine dependence, and its filings provide formal detail on this business focus, its capital structure, and material events.
Investors reviewing ACHV’s filings can find current reports on Form 8-K that disclose items such as quarterly financial results, executive leadership changes, material definitive agreements, and equity offerings. For example, recent 8-K filings reference press releases announcing financial results, the appointment or resignation of senior officers, and an underwriting agreement for an offering of common stock and warrants under an effective shelf registration statement.
In addition to 8-Ks, Achieve files periodic reports such as Forms 10-K and 10-Q (not reproduced here) that typically include more extensive discussion of its cytisinicline clinical program, risk factors, and financial condition. These documents are central for understanding how the company presents its late-stage development activities, including the FDA’s acceptance of its New Drug Application for cytisinicline for smoking cessation and the status of its vaping cessation program.
On Stock Titan, ACHV filings are updated as they are made available through EDGAR, and AI-powered tools can help summarize lengthy reports, highlight key sections, and surface information about topics such as clinical trial progress, financing arrangements, and governance changes. Users can also review insider and executive-related disclosures reported via Forms 3, 4, and 5 when available, to see transactions and compensatory arrangements that Achieve reports for its officers and directors.
By using this page, readers can quickly locate Achieve’s official SEC documents and use AI-generated insights to better understand how the company reports its operations, cytisinicline development, and material corporate events in a regulatory context.
Achieve Life Sciences details its strategy to commercialize cytisinicline, a smoking and vaping cessation drug, while warning of substantial doubt about its ability to continue as a going concern without new capital. The FDA has accepted its NDA for smoking cessation, with a PDUFA target of June 20, 2026 and potential approval delays tied to observations at a third‑party manufacturer. Cytisinicline has shown strong Phase 3 efficacy and a favorable safety profile, and also holds Breakthrough Therapy designation and a Commissioner’s National Priority Voucher for vaping cessation. As of June 30, 2025, non‑affiliate equity value was $103,958,994, and 53,239,988 common shares were outstanding as of March 24, 2026.
Achieve Life Sciences reported a larger net loss in 2025 as it advances cytisinicline toward potential approval and commercialization. For 2025, the company posted a net loss of $54.6 million on total operating expenses of $54.9 million, compared to a net loss of $39.8 million in 2024. Cash, cash equivalents, and marketable securities were $36.4 million as of December 31, 2025.
The FDA has accepted Achieve’s New Drug Application for cytisinicline for adult smoking cessation and assigned a PDUFA date of June 20, 2026. Achieve anticipates a potential U.S. commercial launch in the first half of 2027 and has partnered with Adare Pharma Solutions to manufacture cytisinicline in the U.S., aiming to provide supply chain redundancy and potential cost savings. Clinical data from the ORCA program and published studies support cytisinicline’s efficacy and tolerability in smoking cessation, including in people with COPD and those with multiple prior quit attempts.
Achieve Life Sciences Chief Medical Officer receives a new stock option grant. On January 28, 2026, Mark Lawrence Rubinstein was awarded stock options covering 180,000 shares of Achieve Life Sciences common stock at an exercise price of $4.36 per share.
The option will vest as to one quarter of the total award on the first anniversary of January 28, 2026, then in substantially equal monthly installments over the following 36 months, as long as he continues providing service to the company on each vesting date.
Achieve Life Sciences Chief Financial Officer granted 180,000 stock options. The Form 4 reports that CFO Mark K. Oki received a stock option to buy 180,000 shares of common stock at an exercise price of $4.36 per share.
The option vests as to one quarter of the total award on the first anniversary of January 28, 2026, then in substantially equal monthly installments over the following 36 months, as long as he continues providing service to the company on each vesting date.
Achieve Life Sciences, Inc. granted Chief Commercial Officer Jaime Xinos a stock option for 180,000 shares of common stock on January 28, 2026. The option has an exercise price of $4.36 per share.
One quarter of the award will vest on the first anniversary of January 28, 2026, with the remaining shares vesting in substantially equal monthly installments over the following 36 months, contingent on continued service. After the grant, Xinos beneficially owned 180,000 derivative securities directly.
Achieve Life Sciences, Inc. reported a new equity award for Chief Operations Officer Craig Donnelly. He received a stock option to buy 180,000 shares of common stock at an exercise price of $4.36 per share, dated January 28, 2026.
The option vests as to one-quarter of the total award on the first anniversary of January 28, 2026, then in substantially equal monthly installments over the following 36 months, contingent on his continued service. After this grant, Donnelly beneficially owns 180,000 stock options directly.
Achieve Life Sciences chief executive Richard Alistair Stewart received a new stock option grant covering 645,000 shares of common stock. The options have an exercise price of $4.36 per share and expire on January 28, 2036.
According to the filing, one quarter of the award will vest on the first anniversary of January 28, 2026, with the remaining options vesting in substantially equal monthly installments over the following 36 months, contingent on Stewart continuing to provide service to the company on each vesting date.
Achieve Life Sciences, Inc. reported that Principal Accounting Officer Jerry Wan received a grant of stock options for 70,300 shares of common stock at an exercise price of $4.36 per share on January 28, 2026.
The options are held directly and vest over time. One quarter of the award will vest on the first anniversary of January 28, 2026, with the remaining options vesting in substantially equal monthly installments over the following 36 months, contingent on continued service with the company.
Achieve Life Sciences, Inc. received an updated ownership report on its common stock from Franklin Resources, Inc. and affiliates on December 31, 2025. The filing states beneficial ownership of 6,369,193 shares, representing 11.5% of Achieve’s common stock, including 2,000,000 shares issuable upon exercise of warrants.
Franklin Advisers, Inc. is reported as having sole voting and dispositive power over these 6,369,193 shares, while Franklin Resources, Inc., Charles B. Johnson, and Rupert H. Johnson, Jr. report no direct voting or dispositive power and disclaim pecuniary interest. The securities are held for clients of Franklin’s investment management subsidiaries in the ordinary course of business, not to change or influence control of Achieve.
The filing notes that Franklin Biotechnology Discovery Fund, a sub-fund of Franklin Templeton Investment Funds, has an interest in 4,094,440 shares, or 7.4% of Achieve’s common stock, as part of the overall reported position.