Achieve Life Sciences Inc Stock Price, News & Analysis

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.

Achieve Life Sciences (NASDAQ: ACHV), a late-stage specialty pharmaceutical company developing cytisinicline for smoking cessation, has scheduled its first quarter 2025 financial results announcement and corporate update for May 13, 2025, at 8:30 AM EDT. The company will provide updates on their cytisinicline development program during the call.

Investors can access the webcast through the provided link or join via phone by dialing 877-269-7756 (U.S. & Canada) or 201-689-7817 (International) using conference ID 13752599. A replay will be available approximately three hours after the call and remain accessible on the website for 90 days.

Achieve Life Sciences (NASDAQ: ACHV) has published complete results of its ORCA-3 Phase 3 trial in JAMA Internal Medicine, evaluating cytisinicline for smoking cessation. The trial, involving 792 U.S. adults, demonstrated significant efficacy in both 6- and 12-week treatment durations.

The study showed that cytisinicline effectively increased quit rates and reduced nicotine cravings through 24 weeks. Trial participants averaged 53 years old, smoked 20 cigarettes daily, with a 36-year smoking history and four prior quit attempts. The drug's selective targeting of nicotine receptors resulted in better tolerability compared to existing treatments.

The company plans to submit a New Drug Application (NDA) to the FDA in June 2025.

Achieve Life Sciences (NASDAQ: ACHV) has announced its Q4 and year-end 2024 financial results, reaffirming plans to submit its New Drug Application (NDA) for cytisinicline by end of Q2 2025. The company reached key milestones in its ORCA-OL long-term exposure trial, including completing enrollment of 479 participants and meeting the FDA requirement of 300 participants receiving six months of cytisinicline treatment.

The company reported positive safety reviews from two Data Safety Monitoring Committee assessments of the ORCA-OL trial. Financial results show cash, equivalents, and marketable securities of $34.4 million as of December 31, 2024. Operating expenses were $12.2 million for Q4 and $39.1 million for the full year, with net losses of $12.4 million and $39.8 million respectively.

Additionally, Achieve received FDA agreement that one Phase 3 trial (ORCA-V2) would be acceptable for a vaping cessation indication as a supplemental NDA, with plans to initiate this trial in H1 2026, subject to funding availability.