Achieve Life Sciences Inc Stock Price, News & Analysis

Achieve Life Sciences (NASDAQ:ACHV) announced the FDA's acceptance of its New Drug Application (NDA) for cytisinicline, a novel smoking cessation treatment. The FDA has set a PDUFA target date of June 20, 2026, marking a significant milestone in potentially introducing the first new FDA-approved smoking cessation pharmacotherapy in two decades.

The NDA is supported by comprehensive data from the ORCA-2 and ORCA-3 Phase 3 trials, involving over 2,000 participants. The trials demonstrated significantly higher smoking abstinence rates with cytisinicline compared to placebo, both at the end of treatment and through week 24. Safety data includes over 400 participants with six-month exposure and 200 with one-year exposure, showing no new safety concerns.

Achieve Life Sciences (NASDAQ:ACHV), a late-stage pharmaceutical company developing cytisinicline for smoking cessation, has announced its participation in two upcoming investor conferences in New York. CEO Rick Stewart will present at the H.C. Wainwright Global Investment Conference on September 8, 2025, participating in a fireside chat at 11:00 AM ET. Additionally, the company will attend the Lake Street Best Ideas Growth Conference (BIG9) on September 11, 2025, for one-on-one meetings with investors.

Achieve Life Sciences (NASDAQ: ACHV) reported significant Q2 2025 milestones, including the submission of a New Drug Application (NDA) to the FDA for cytisinicline, their smoking cessation treatment. The company secured a strategic partnership with Omnicom for commercialization and raised $49.3 million through a public offering.

Key achievements include meeting FDA long-term exposure requirements in the ORCA-OL trial and publication of Phase 3 ORCA-3 results in JAMA Internal Medicine. The company reported $55.4 million in cash and equivalents as of June 30, with a net loss of $12.7 million for Q2 2025.

Achieve Life Sciences (NASDAQ:ACHV), a late-stage pharmaceutical company developing cytisinicline for smoking cessation, announced its participation in the BTIG Virtual Biotechnology Conference on July 29-30, 2025. CEO Rick Stewart will engage in a fireside chat with BTIG Biotechnology Analyst Julian Harrison on July 29 at 3:20 pm EDT.

The company focuses on developing treatments for nicotine dependence through its cytisinicline program. Interested parties can register for the conference by contacting BTIG directly.

Achieve Life Sciences (NASDAQ:ACHV), a late-stage specialty pharmaceutical company, will release its second quarter 2025 financial results on Thursday, August 7, 2025, at 8:30 AM EDT. The company, which focuses on developing cytisinicline for nicotine dependence and smoking cessation, will also provide updates on their development program during the call.

Investors can access the webcast through the company's website or join via phone by dialing 877-269-7756 (U.S. & Canada) or 201-689-7817 (International) with conference ID 13754433. A replay will be available approximately three hours after the call and remain archived for 90 days.

Achieve Life Sciences (NASDAQ: ACHV), a late-stage pharmaceutical company developing cytisinicline for smoking cessation, has announced the closing of its public offering. The company successfully raised $45.0 million in gross proceeds through the offering of 15,000,000 shares of common stock and warrants to purchase up to 16,766,666 shares at $3.00 per share and accompanying warrant.

The offering includes warrants to purchase up to 1,766,666 additional shares issued following the underwriters' partial exercise of their option. The proceeds will be used to fund cytisinicline's advancement through potential FDA marketing approval and for working capital purposes. Citizens Capital Markets and Raymond James served as joint book-running managers, with Lake Street Capital Markets acting as financial advisor.

Achieve Life Sciences (NASDAQ:ACHV) has announced the pricing of an underwritten public offering of 15 million shares of common stock and accompanying warrants at $3.00 per share, aiming to raise approximately $45.0 million in gross proceeds.

The offering includes common warrants to purchase up to 15 million additional shares, exercisable at $3.00 per share or for pre-funded warrants at $2.999, valid for five years. Underwriters have a 30-day option to purchase up to 2.25 million additional shares and/or warrants. The company plans to use the proceeds to fund the advancement of cytisinicline through potential FDA marketing approval and for working capital purposes.

Achieve Life Sciences (NASDAQ:ACHV), a late-stage pharmaceutical company developing cytisinicline for smoking cessation, has announced a proposed underwritten public offering of common stock and accompanying warrants. The offering includes pre-funded warrants and grants underwriters a 30-day option to purchase up to an additional 15% of shares and warrants.

The company plans to use the proceeds to fund the advancement of cytisinicline through potential FDA marketing approval and for working capital. Citizens Capital Markets and Raymond James are serving as joint book-running managers, with Lake Street Capital Markets as financial advisor.

Achieve Life Sciences (NASDAQ:ACHV) has partnered with Omnicom (NYSE:OMC) to spearhead the commercial launch of cytisinicline, potentially the first new nicotine dependence treatment in nearly 20 years. The collaboration follows Achieve's NDA submission on June 25, 2025, after successful completion of two Phase 3 studies.

The partnership leverages Omnicom's cross-agency expertise, including Credera, Goodby, Silverstein & Partners, DDB Health, and Ketchum Health, to develop an AI-enabled marketing technology platform. The launch strategy will incorporate generative AI, predictive analytics, and social listening to enhance targeting and personalization, alongside partnerships with healthcare apps, pharmacies, and data providers.

This initiative aims to address a significant public health crisis, with over 29 million U.S. adults still smoking, making it the leading cause of preventable death and disease in the country.