Achieve Life Sciences SEC filings document current reports on operating results, cytisinicline development updates, governance matters, material agreements, and capital-structure disclosures. Recent Form 8-K filings include furnished financial-results releases and business updates tied to the company’s late-stage specialty pharmaceutical focus on cytisinicline for nicotine dependence.
The filing record also covers executive and board changes, compensatory arrangements, consulting and separation agreements, shareholder voting matters, security-structure disclosures, and clinical or regulatory disclosures related to the cytisinicline program. These filings provide formal records of the company’s corporate events, financial-condition updates, and governance actions as a public biotechnology issuer.
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.
Achieve Life Sciences, Inc. has filed a shelf registration statement on Form S-3 to register up to $300,000,000 of securities. The company may periodically offer common stock, preferred stock, debt securities, warrants, subscription rights and units in one or more future offerings, with specific prices and terms detailed in separate prospectus supplements.
Achieve is a late-stage clinical specialty pharmaceutical company focused on developing and commercializing cytisinicline to treat nicotine dependence from combustible cigarettes and e‑cigarettes. Any net proceeds from future sales under this shelf may be used for general corporate purposes, including research and clinical development, manufacturing and commercialization activities, working capital, debt reduction, potential acquisitions or investments, and capital expenditures.