Welcome to our dedicated page for Achieve Life Sciences news (Ticker: ACHV), a resource for investors and traders seeking the latest updates and insights on Achieve Life Sciences stock.
Achieve Life Sciences Inc (ACHV) is a clinical-stage pharmaceutical company advancing cytisinicline, a plant-based treatment for nicotine addiction. This page serves as the definitive source for official press releases, clinical trial updates, and regulatory developments related to their smoking cessation research.
Investors and healthcare professionals will find timely updates on Phase 3 trial results, FDA communications, and strategic partnerships. All content is sourced directly from company filings and verified announcements, maintaining strict compliance with financial disclosure regulations.
Key coverage areas include clinical trial milestones, intellectual property developments, and manufacturing updates. The curated news selection enables efficient tracking of cytisinicline's progress through regulatory pathways and potential market entry.
Bookmark this page for direct access to Achieve Life Sciences' latest verified updates. For comprehensive analysis of nicotine addiction treatment developments, revisit regularly as new information becomes available through official channels.
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.
Achieve Life Sciences (Nasdaq: ACHV), a late-stage specialty pharmaceutical company developing cytisinicline for smoking cessation, has announced its participation in the Barclays 27th Annual Global Healthcare Conference. The conference will take place from March 11-13, 2025, in Miami, FL.
CEO Rick Stewart will deliver a presentation on Wednesday, March 12, 2025, at 11:30 AM EDT. Investors and interested parties can access both the live webcast and replay of the presentation through the Investor section of the company's website.
Achieve Life Sciences (NASDAQ: ACHV), a late-stage specialty pharmaceutical company developing cytisinicline for smoking cessation, has scheduled its fourth quarter and year-end 2024 financial results announcement for March 11, 2025, at 8:30 AM EDT. The company will also provide updates on its cytisinicline development program during the presentation.
Investors and interested parties can access the webcast through the 4Q24 Webcast link or join via telephone by dialing 877-269-7756 (U.S. & Canada) or 1-201-689-7817 (International) using conference ID 13751745. A replay of the webcast will be available approximately three hours after the call and remain accessible on the website for 90 days.
Achieve Life Sciences (Nasdaq: ACHV), a late-stage specialty pharmaceutical company specializing in cytisinicline for smoking cessation and nicotine dependence, has announced its participation in the Oppenheimer 35th Annual Healthcare Life Sciences Conference.
CEO Rick Stewart will deliver a presentation at the virtual conference on February 11, 2025, at 10:00 a.m. EST. Interested parties can access more information through their banking representatives or by visiting the company's Investor Relations website.
Achieve Life Sciences (NASDAQ: ACHV) announced positive results from the second Data Safety Monitoring Committee (DSMC) review of its ORCA-OL trial, evaluating long-term exposure of 3 mg cytisinicline for smoking and nicotine vaping cessation. The DSMC found no unexpected treatment-related adverse events and noted excellent medication adherence, allowing the study to continue without modifications.
The trial has reached significant milestones, including the enrollment of 479 participants across 29 U.S. clinical sites and achieving the goal of over 300 participants completing six months of cytisinicline treatment. This milestone is important for the company's planned New Drug Application (NDA) submission in Q2 2025.
The ORCA-OL trial aims to meet FDA safety data requirements, which include six-month safety data from at least 300 participants and one-year cumulative exposure data from minimum 100 participants prior to potential NDA approval. Achieve has already completed two Phase 3 trials involving over 1,600 subjects.
Achieve Life Sciences (NASDAQ: ACHV) has appointed two new directors to its Board: Dr. Kristen Slaoui and Nancy Phelan, while Dr. Vaughn Himes has retired but will continue as a consultant. Dr. Slaoui, currently Chief Corporate Development Officer at Galderma, brings extensive experience in strategic transactions and drug development from her 20-year tenure at GSK, where she executed over $30 billion in deals.
Nancy Phelan, Senior Vice President at Trinity Life Sciences, contributes over 25 years of executive leadership in biopharma, specializing in digital transformation and innovative customer engagement solutions. The appointments come as Achieve approaches its first NDA submission for cytisinicline for smoking cessation.
Achieve Life Sciences (NASDAQ: ACHV) has reached a critical milestone in its ORCA-OL clinical trial, with over 300 participants completing six months of cumulative cytisinicline treatment for smoking cessation. This achievement fulfills a key FDA requirement for the planned New Drug Application (NDA) submission, which remains on track for Q2 2025.
The Data Safety Monitoring Committee review has identified no safety concerns, and the study continues as planned. The FDA has previously expressed support for the NDA submission based on data from two completed Phase 3 trials (ORCA-2 and ORCA-3), which assessed efficacy for six-week and 12-week treatment durations.
The FDA requires both six-month and one-year exposure safety data, with the latter to be submitted prior to potential NDA approval. To date, Achieve has completed two Phase 3 trials involving more than 1,600 subjects who smoke cigarettes or vape nicotine e-cigarettes.
Achieve Life Sciences (Nasdaq: ACHV) has announced its participation in the 43rd Annual J.P. Morgan Healthcare Conference in San Francisco, January 13-16, 2025. The company's management team will conduct in-person meetings to discuss their cytisinicline program for smoking and vaping cessation.
The company has completed two Phase 3 clinical trials involving over 1,600 subjects for smoking cessation and one Phase 2 trial for nicotine e-cigarette cessation. Achieve plans to submit a New Drug Application (NDA) for cytisinicline as a smoking cessation aid in Q2 2025, followed by the initiation of a Phase 3 trial for vaping cessation in Q3 2025.
Achieve Life Sciences (Nasdaq: ACHV) has appointed Mark Oki as Chief Financial Officer, effective December 5, 2024. Oki will manage the company's financial strategy and operations, including accounting, investor relations, IT, legal, and administrative functions. He brings over 25 years of financial leadership experience in biotechnology and pharmaceutical industries, previously serving as CFO at Aytu BioPharma and Vivus
As part of his employment package, Oki received options to purchase 72,000 shares and 168,000 performance-based RSUs. The stock options vest over three years, while RSUs vest based on performance objectives. The company also granted stock options to three other new employees totaling 109,000 shares, vesting over four years.
