Achieve Life Sciences Inc Stock Price, News & Analysis

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.

Achieve Life Sciences (NASDAQ: ACHV) has submitted a New Drug Application (NDA) to the FDA for cytisinicline, a novel treatment for nicotine dependence in adult smoking cessation. If approved, cytisinicline would become the first new FDA-approved pharmacotherapy for nicotine dependence in 20 years.

The NDA submission is supported by data from two Phase 3 trials (ORCA-2 and ORCA-3), involving over 2,000 clinical trial participants. Both studies demonstrated significantly higher abstinence rates with cytisinicline compared to placebo at both 6 and 12-week treatment durations. Additional safety data from the ORCA-OL long-term trial, involving over 300 participants with six months of exposure, showed no new safety concerns.

Achieve Life Sciences (NASDAQ: ACHV), a late-stage specialty pharmaceutical company developing cytisinicline for nicotine dependence and smoking cessation, has announced its participation in the upcoming Jefferies Global Healthcare Conference. The conference will take place from June 3-5, 2025, in New York City. CEO Rick Stewart will deliver a presentation on Wednesday, June 4, 2025, at 5:30 PM EDT. Investors can access both the live webcast and replay of the presentation through the company's Investor Relations website.

Achieve Life Sciences (NASDAQ: ACHV) will present new data from its Phase 3 ORCA-3 study of cytisinicline at the 2025 ATS International Conference. The data demonstrates that cytisinicline significantly reduced nicotine cravings and intake, even in participants who didn't completely quit smoking. The drug's dual mechanism as a selective partial agonist and antagonist showed significant reductions in craving scores (p=0.0001) and decreased cotinine levels nearly four times more compared to placebo - equivalent to reducing consumption by about a pack per week.

The company plans to submit its New Drug Application next month. The treatment showed promising results for the general smoking population and particularly high quit rates among COPD patients in Phase 3 trials. If approved, cytisinicline could help address smoking cessation needs for approximately 29 million U.S. adults who continue to smoke.

Achieve Life Sciences (NASDAQ: ACHV) reported its Q1 2025 financial results and provided updates on its cytisinicline program for smoking cessation. The company plans to submit a New Drug Application (NDA) to the FDA in June 2025. Key highlights include: publication of Phase 3 ORCA-3 trial results in JAMA Internal Medicine involving 792 U.S. adults, completion of long-term exposure requirements with ≥300 participants receiving six months and 100+ participants receiving one year of treatment, and a favorable third safety review by the Data Safety Monitoring Committee. Financial results show cash position of $23.2 million, operating expenses of $12.9 million, and a net loss of $12.8 million for Q1 2025. The company's cytisinicline could become the first new FDA-approved smoking cessation treatment in nearly 20 years.