Every 8-K that Achieve Life Sciences, Inc. (ACHV) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 8-K covers material events a company has to report between its quarterly reports, so if you follow ACHV and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full ACHV filings page.
Achieve Life Sciences, Inc. entered into an Open Market Sale agreement with Jefferies LLC to establish an at-the-market equity offering program. Under this ATM program, the company may, at its sole discretion, sell shares of common stock with an aggregate offering price of up to $150.0 million from time to time through Jefferies as sales agent.
Jefferies will receive up to 3.0% of the aggregate gross proceeds from any sales and will use commercially reasonable efforts to place the shares in transactions deemed to be an “at the market offering” under Rule 415(a)(4). The program can be suspended by the company at any time and will end upon sale of the maximum program amount or termination of the agreement. Net proceeds are currently intended for commercialization of cytisinicline, funding a Phase 3 clinical trial for cytisinicline for e-cigarette cessation, and for working capital and general corporate purposes.
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, Inc. amended its certificate of incorporation to increase authorized common stock from 150,000,000 shares to 300,000,000 shares, following approval at its annual meeting of stockholders.
Stockholders elected nine directors, ratified PricewaterhouseCoopers LLP as independent auditor for the year ending December 31, 2026, and approved on an advisory basis the compensation of named executive officers.
Achieve Life Sciences is expanding its board by appointing Jeff Farrow and Reid Waldman, M.D. as directors, effective May 29, 2026. They will also serve in key committee leadership roles, including chairing the Audit Committee and the Compensation Committee.
Under the company’s non-employee director compensation program, each new director will receive a pro-rated $40,000 cash retainer for the fiscal year ending December 31, 2026, plus additional cash compensation for committee service. Each will also receive a stock option to purchase 47,250 shares of common stock, vesting monthly over three years, subject to continued service.
Achieve Life Sciences reported first quarter 2026 results and highlighted a large financing and leadership changes as it advances cytisinicline toward potential approval. Cash, cash equivalents and marketable securities were $29.3 million as of March 31, 2026, excluding estimated net proceeds of about $168.6 million from an April 2026 private placement that totals up to $354 million, including $180 million upfront and $174 million in milestone-driven warrants.
Total operating expenses for the quarter were $10.5 million, resulting in a net loss of $10.2 million or $0.19 per share. The company’s New Drug Application for cytisinicline has a Prescription Drug User Fee Act date of June 20, 2026.
The board appointed Christopher Martin as a director, with a pro-rated $40,000 annual retainer and options for 47,250 shares vesting over three years. Chairman Thomas King will resign effective June 8, 2026, with Lucian Iancovici, MD, becoming Chair, and Chief Commercial Officer Jaime Xinos will depart effective May 31, 2026.
Achieve Life Sciences entered a large private placement, raising approximately $180 million upfront through 49,418,069 common shares, 100,500 pre-funded warrants and accompanying warrants, with up to about $354 million in total gross proceeds if all milestone-driven warrants are exercised. The securities are sold at $3.635 per share and warrant combination, or $3.634 per pre-funded warrant and warrant, with common warrants exercisable at $3.51 per share, generally expiring shortly after any FDA approval of cytisinicline for smoking cessation. The company plans to use proceeds to fund a Phase 3 trial in e-cigarette cessation, commercialize cytisinicline, and for general corporate purposes. In connection with the financing, long-time CEO Richard Stewart will step down, and Andrew Goldberg, MD will become Chief Executive Officer and join the board, supported by substantial equity awards tied to share-price and growth milestones, while new investor-designated directors are added to the board.
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 (ACHV) reported that it furnished, not filed, a press release announcing its financial results for the third quarter ended September 30, 2025. The company submitted the press release as Exhibit 99.1 to an Item 2.02 Form 8-K dated November 6, 2025.
The furnishing designation means the information is not subject to liability under Section 18 of the Exchange Act and is not incorporated by reference unless expressly stated.
Achieve Life Sciences, Inc. reports that it has finalized separation terms with Dr. Cindy Jacobs, who previously informed the board she would resign as Chief Medical Officer and President effective October 6, 2025. On that date, the company and Dr. Jacobs entered into a Separation Agreement and a related Consulting Agreement.
Under these agreements, Dr. Jacobs will continue to provide consulting services until the first business day after U.S. Food and Drug Administration approval of the company’s New Drug Application for cytisinicline. During this consulting period, her existing equity awards will continue to vest. She will receive a lump-sum cash severance of $101,296, accelerated vesting of the unvested portions of her January 2023 and January 2024 time-based stock options upon the end of her consultancy at or after NDA approval, and an extension of the exercise period for those options to 12 months after that termination. The company will also reimburse up to $10,000 in legal fees related to these agreements.
Achieve Life Sciences, Inc. reported that Dr. Cindy Jacobs has chosen to resign from her roles as Chief Medical Officer and President, effective October 6, 2025. She informed the board on September 5, 2025. The company is negotiating a consulting agreement so Dr. Jacobs can continue providing advisory services after her departure.
Achieve Life Sciences (NASDAQ: ACHV) filed an 8-K announcing a firm-commitment public offering of 15,000,000 common shares and five-year warrants at $3.00 per unit, plus a 30-day option for 2,250,000 additional units. Net proceeds are estimated at $41.3 million after underwriting fees and expenses. Each warrant is immediately exercisable at $3.00 per share (or $2.999 for pre-funded warrants) and capped at 9.99% beneficial ownership; pre-funded warrants have a $0.001 strike and no expiry. The deal is being executed under the effective shelf registration (File No. 333-280585) and is expected to close on June 30 2025, subject to customary conditions. Exhibits include the underwriting agreement, warrant forms, legal opinion and related press releases. Proceeds are earmarked for general corporate purposes as outlined in the prospectus supplement, and the filing contains customary forward-looking-statement disclaimers.