Achieve Life Sciences Inc - ACHV STOCK NEWS

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.

Achieve Life Sciences (Nasdaq: ACHV) announced successful completion of its End-of-Phase 2 FDA meeting for cytisinicline as a potential first-in-class treatment for vaping cessation. The FDA agreed that one Phase 3 trial (ORCA-V2), along with the completed Phase 2 ORCA-V1 trial, would suffice for a vaping cessation indication. The planned Phase 3 study will evaluate 3 mg cytisinicline three times daily versus placebo in approximately 800 adults who use e-cigarettes. The trial is targeted to begin in Q3 2025, addressing an unmet need among 11 million U.S. adult vapers, of whom 60% want to quit.

Achieve Life Sciences (Nasdaq: ACHV), a late-stage pharmaceutical company focused on developing cytisinicline for nicotine dependence treatment, has announced its participation in two major investor conferences. The company's CEO Rick Stewart and management team will attend the Jefferies London Healthcare Conference (November 19-21, 2024) in London and the Piper Sandler 36th Annual Healthcare Conference (December 3-5, 2024) in New York City. Interested parties can arrange one-on-one meetings through banking representatives or via the company's Investor Relations website.

Achieve Life Sciences (NASDAQ: ACHV) reported Q3 2024 financial results and provided updates on its cytisinicline development program. Key developments include completed enrollment in the Phase 3 ORCA-OL trial with 479 participants, FDA Breakthrough Therapy designation for vaping cessation, and leadership changes including Richard Stewart as CEO. The company reported cash and investments of $42.9 million, with operating expenses of $12.5 million for Q3 and a net loss of $12.5 million. Achieve plans to submit an NDA in Q2 2025 and is preparing for U.S. market launch with an expanded commercial team.

Achieve Life Sciences (Nasdaq: ACHV), a late-stage pharmaceutical company focused on developing cytisinicline for nicotine dependence treatment, will release its third quarter 2024 financial results and provide a corporate update on November 7, 2024, at 4:30 PM EST. The company will host a conference call and webcast accessible via phone or online streaming. The webcast replay will be available approximately three hours after the call and remain archived on the website for 90 days.