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.
Filing: Schedule 13G/A reporting beneficial ownership in Achieve Life Sciences, Inc. (CUSIP 004468500) related to event dated 06/30/2025.
Holdings: Franklin Advisers, Inc. reports 8,640,039 shares (representing 16.0% of the class) and has sole voting and sole dispositive power over those shares. The filing states that 4,181,025 of the reported shares are issuable upon exercise of warrants and are included in the total.
Named entities & funds: Franklin Resources, Inc.; Charles B. Johnson; Rupert H. Johnson, Jr.; Franklin Advisers, Inc. Franklin Biotechnology Discovery Fund holds 4,476,098 shares (8.3%) and a Franklin Templeton sub-fund holds 4,163,770 shares (7.7%).
Other: Filing includes joint filing agreement, limited powers of attorney, Item 10 certification that holdings were acquired and are held in the ordinary course of business, and is signed by Thomas C. Mandia on 08/01/2025.
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.
Achieve Life Sciences, Inc. (NASDAQ: ACHV) has launched a follow-on public offering of 15,000,000 shares of common stock bundled with five-year common warrants for an equal number of shares at an exercise price of $3.00. The securities are priced at $3.00 per share/warrant unit, versus the 26-Jun-2025 closing price of $3.51, implying a ~14% discount. Gross proceeds are projected at $45.0 million; after underwriting fees of $0.18 per unit, net proceeds before expenses total $42.3 million. An additional 30-day over-allotment option allows underwriters to purchase up to 2,250,000 extra shares and/or warrants, which could raise total net proceeds to $48.6 million.
The common warrants (and any pre-funded warrants chosen by investors) are immediately exercisable, subject to ownership caps, and expire five years from issuance. Neither the common warrants nor the pre-funded warrants will be listed, limiting secondary-market liquidity.
Management indicates the capital will support regulatory and pre-launch activities for cytisinicline, the company’s smoking-cessation therapy. On the same date, ACHV submitted its NDA to the FDA following two positive Phase 3 trials and an open-label safety study, and appointed Omnicom as commercial launch partner contingent on regulatory approval.
As a smaller reporting company, ACHV is using its July 8 2024 shelf registration (No. 333-280585). The offering is underwritten by Citizens Capital Markets and Raymond James, with settlement expected on 30-Jun-2025.
Key investor considerations:
- Financing materially strengthens cash reserves ahead of a potential U.S. launch.
- Issuance increases the share count and introduces 15 million warrants, creating dilution and overhang.
- Unlisted warrants may constrain liquidity for warrant holders.
Achieve Life Sciences, Inc. (Nasdaq: ACHV) has filed a preliminary prospectus supplement (Form 424B5) for a public offering of (i) shares of common stock and accompanying five-year common warrants, or (ii) pre-funded warrants (exercise price $0.001) plus the same warrants, at the purchaser’s election. Exact share counts, warrant coverage and pricing are still blank in the preliminary document. Each unit is immediately separable; however, neither the pre-funded nor the common warrants will be listed on Nasdaq, limiting their liquidity. The company has granted underwriters Citizens Capital Markets and Raymond James a 30-day option to purchase additional shares and/or warrants.
Achieve qualifies as a smaller reporting company and intends to use reduced disclosure requirements. Its common stock last traded at $3.80 on 25 June 2025. Investors are urged to review the extensive risk factors beginning on page S-8.
Strategic and clinical updates disclosed in the filing:
- NDA submission (26 June 2025): Cytisinicline New Drug Application for adult smoking cessation filed with the FDA, supported by the Phase 3 ORCA-2 and ORCA-3 trials and long-term safety data from ORCA-OL.
- Breakthrough Therapy Designation: Previously received for a future vaping-cessation indication following a successful end-of-Phase 2 meeting with the FDA.
- Commercial readiness: Omnicom Group selected as strategic innovation partner and agency of record to prepare for a potential U.S. launch if FDA approves cytisinicline.
The transaction, once priced, is expected to provide fresh capital for regulatory, pre-launch and general corporate purposes but will dilute existing shareholders. No earnings, revenue or use-of-proceeds detail beyond standard language is provided in this preliminary filing.
Achieve Life Sciences, Inc. (Nasdaq: ACHV) has filed a preliminary prospectus supplement (Form 424B5) for a public offering of (i) shares of common stock and accompanying five-year common warrants, or (ii) pre-funded warrants (exercise price $0.001) plus the same warrants, at the purchaser’s election. Exact share counts, warrant coverage and pricing are still blank in the preliminary document. Each unit is immediately separable; however, neither the pre-funded nor the common warrants will be listed on Nasdaq, limiting their liquidity. The company has granted underwriters Citizens Capital Markets and Raymond James a 30-day option to purchase additional shares and/or warrants.
Achieve qualifies as a smaller reporting company and intends to use reduced disclosure requirements. Its common stock last traded at $3.80 on 25 June 2025. Investors are urged to review the extensive risk factors beginning on page S-8.
Strategic and clinical updates disclosed in the filing:
- NDA submission (26 June 2025): Cytisinicline New Drug Application for adult smoking cessation filed with the FDA, supported by the Phase 3 ORCA-2 and ORCA-3 trials and long-term safety data from ORCA-OL.
- Breakthrough Therapy Designation: Previously received for a future vaping-cessation indication following a successful end-of-Phase 2 meeting with the FDA.
- Commercial readiness: Omnicom Group selected as strategic innovation partner and agency of record to prepare for a potential U.S. launch if FDA approves cytisinicline.
The transaction, once priced, is expected to provide fresh capital for regulatory, pre-launch and general corporate purposes but will dilute existing shareholders. No earnings, revenue or use-of-proceeds detail beyond standard language is provided in this preliminary filing.
Achieve Life Sciences, Inc. (Nasdaq: ACHV) has filed a preliminary prospectus supplement (Form 424B5) for a public offering of (i) shares of common stock and accompanying five-year common warrants, or (ii) pre-funded warrants (exercise price $0.001) plus the same warrants, at the purchaser’s election. Exact share counts, warrant coverage and pricing are still blank in the preliminary document. Each unit is immediately separable; however, neither the pre-funded nor the common warrants will be listed on Nasdaq, limiting their liquidity. The company has granted underwriters Citizens Capital Markets and Raymond James a 30-day option to purchase additional shares and/or warrants.
Achieve qualifies as a smaller reporting company and intends to use reduced disclosure requirements. Its common stock last traded at $3.80 on 25 June 2025. Investors are urged to review the extensive risk factors beginning on page S-8.
Strategic and clinical updates disclosed in the filing:
- NDA submission (26 June 2025): Cytisinicline New Drug Application for adult smoking cessation filed with the FDA, supported by the Phase 3 ORCA-2 and ORCA-3 trials and long-term safety data from ORCA-OL.
- Breakthrough Therapy Designation: Previously received for a future vaping-cessation indication following a successful end-of-Phase 2 meeting with the FDA.
- Commercial readiness: Omnicom Group selected as strategic innovation partner and agency of record to prepare for a potential U.S. launch if FDA approves cytisinicline.
The transaction, once priced, is expected to provide fresh capital for regulatory, pre-launch and general corporate purposes but will dilute existing shareholders. No earnings, revenue or use-of-proceeds detail beyond standard language is provided in this preliminary filing.
Achieve Life Sciences, Inc. (Nasdaq: ACHV) has filed a preliminary prospectus supplement (Form 424B5) for a public offering of (i) shares of common stock and accompanying five-year common warrants, or (ii) pre-funded warrants (exercise price $0.001) plus the same warrants, at the purchaser’s election. Exact share counts, warrant coverage and pricing are still blank in the preliminary document. Each unit is immediately separable; however, neither the pre-funded nor the common warrants will be listed on Nasdaq, limiting their liquidity. The company has granted underwriters Citizens Capital Markets and Raymond James a 30-day option to purchase additional shares and/or warrants.
Achieve qualifies as a smaller reporting company and intends to use reduced disclosure requirements. Its common stock last traded at $3.80 on 25 June 2025. Investors are urged to review the extensive risk factors beginning on page S-8.
Strategic and clinical updates disclosed in the filing:
- NDA submission (26 June 2025): Cytisinicline New Drug Application for adult smoking cessation filed with the FDA, supported by the Phase 3 ORCA-2 and ORCA-3 trials and long-term safety data from ORCA-OL.
- Breakthrough Therapy Designation: Previously received for a future vaping-cessation indication following a successful end-of-Phase 2 meeting with the FDA.
- Commercial readiness: Omnicom Group selected as strategic innovation partner and agency of record to prepare for a potential U.S. launch if FDA approves cytisinicline.
The transaction, once priced, is expected to provide fresh capital for regulatory, pre-launch and general corporate purposes but will dilute existing shareholders. No earnings, revenue or use-of-proceeds detail beyond standard language is provided in this preliminary filing.