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.
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, Inc. is a late-stage specialty pharmaceutical company focused on developing and commercializing cytisinicline for nicotine dependence. For the three and six months ended June 30, 2026, it reported net losses of $74.8 million and $84.9 million, compared with $12.7 million and $25.5 million in the prior-year periods. The sharp increase was mainly driven by a non-cash $48.5 million loss from the change in fair value of newly issued warrant liabilities and $8.8 million of warrant issuance costs, along with higher general and administrative expenses and stock-based compensation.
Cash, cash equivalents and marketable securities rose to $187.3 million as of June 30, 2026 from $36.4 million at December 31, 2025, primarily reflecting a $168.2 million April 2026 private placement. Despite this, stockholders’ equity turned negative at $(14.7) million, largely due to recognizing a $182.7 million warrant liability. The company has an accumulated deficit of $345.2 million, no product revenue, and remains dependent on external financing, but management believes existing resources are sufficient to meet obligations for at least the next 12 months. Key risks include obtaining FDA approval for cytisinicline, reliance on third-party manufacturing and plant-derived supply, and an ongoing arbitration with Sopharma over supply arrangements.
Achieve Life Sciences, Inc. reported second quarter 2026 results and major financing and regulatory developments around cytisinicline. The company closed a private placement of up to $354 million, including $180 million upfront and up to $174 million from milestone-based warrants exercisable around potential FDA approval. Cash, cash equivalents, and marketable securities were $187.3 million as of June 30, 2026, supporting the ORCA‑V2 Phase 3 trial, commercialization activities, and general corporate purposes.
On June 20, 2026, Achieve received an FDA Complete Response Letter on its cytisinicline NDA related to cGMP observations at a prior manufacturer and incomplete labeling, with no deficiencies identified for efficacy or clinical safety. The company is transitioning finished product manufacturing to Adare Pharma Solutions, plans to resubmit the NDA in the fourth quarter of 2026, and anticipates potential FDA approval in the first half of 2027 followed by U.S. launch. Net loss for the quarter was $74.8 million, including a non‑cash $48.7 million charge from changes in warrant liabilities, and stockholders’ equity was $(14.7) million.
Achieve Life Sciences director Thomas Sellig received equity awards comprising 25,000 stock options with an exercise price of $6.18 per share and 16,700 restricted stock units (RSUs), each RSU representing one share of common stock.
Both the options and RSUs vest 100% on the earlier of July 27, 2027 or the date immediately prior to Achieve Life Sciences’ 2027 annual meeting of stockholders, contingent on his continued service.
Achieve Life Sciences director Christopher Nathan received equity compensation on July 27, 2026, consisting of stock options for 25,000 shares with a $6.18 exercise price expiring July 27, 2036, and 16,700 RSUs. Both awards vest 100% on the earlier of July 27, 2027 or immediately before the 2027 annual meeting, subject to continued service.
Achieve Life Sciences, Inc. director Aaron Royston reported equity compensation awards effective July 27, 2026. He received stock options for 25,000 shares at a $6.18 exercise price, expiring July 27, 2036, and 16,700 RSUs. Both awards vest 100% on the earlier of July 27, 2027 or immediately before the 2027 annual stockholders meeting, subject to continued service. The options and RSUs are held for the benefit of venBio Global Strategic Fund V, L.P., with related proceeds remitted to that fund, and Royston disclaims beneficial ownership except for his pecuniary interest.
Waldman Reid Alexander reported acquisition or exercise transactions in this Form 4 filing.
Achieve Life Sciences, Inc. director Reid Alexander Waldman received equity compensation on July 27, 2026, consisting of 25,000 stock options to buy common stock at $6.18 per share, expiring July 27, 2036, and 16,700 RSUs. Both awards vest 100% on the earlier of July 27, 2027 or immediately prior to the 2027 annual meeting, subject to continued service.
Achieve Life Sciences director Stewart Richard Alistair received equity awards on July 27, 2026: stock options for 25,000 shares at an exercise price of $6.18 per share and 16,700 RSUs, each RSU settling into one share. Both awards vest 100% on the earlier of July 27, 2027 or immediately before the 2027 annual meeting of stockholders, subject to continued service, resulting in direct holdings of 25,000 options and 16,700 RSUs. The options expire on July 27, 2036.
Achieve Life Sciences, Inc. granted director Jeffrey S. Farrow equity awards consisting of 25,000 stock options to buy common stock at an exercise price of $6.18 per share, expiring July 27, 2036, and 16,700 RSUs. Both the options and RSUs vest 100% on the earlier of July 27, 2027 or the date immediately prior to the company’s 2027 annual meeting of stockholders, subject to Farrow’s continued service.
Achieve Life Sciences director Nancy R. Phelan received new equity awards. She was granted stock options for 25,000 shares of common stock at an exercise price of $6.18 per share, expiring on July 27, 2036. These options vest 100% on the earlier of July 27, 2027 or immediately before the company’s 2027 annual stockholders’ meeting, subject to her continued service. She also received 16,700 Restricted Stock Units, each representing a contingent right to receive one share of common stock, with the same cliff-vesting schedule and service condition.
Franklin Resources, Inc. and affiliates report beneficial ownership of Achieve Life Sciences, Inc. common stock. Franklin Advisers, Inc. is reported as having sole voting and dispositive power over 8,878,942 shares, representing 8.3% of the common stock.
This position includes 3,925,722 shares issuable upon exercise of warrants. Within this holding, Franklin Biotechnology Discovery Fund has an interest in 5,670,723 shares, or 5.3% of the class. Franklin Resources, its principal shareholders, and subsidiaries disclaim pecuniary interest and do not concede they form a group for Section 13 purposes.