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. (Nasdaq: ACHV) is a specialty pharmaceutical company dedicated to addressing the global nicotine addiction epidemic through the development and commercialization of cytisinicline, a plant-based alkaloid intended for smoking and e-cigarette cessation. The company's main focus is advancing cytisinicline as a viable treatment option to help individuals overcome nicotine dependence, a significant public health concern affecting millions worldwide.
Headquartered in Seattle, Washington, and Vancouver, British Columbia, Achieve Life Sciences has made notable strides in its clinical development programs. The company has successfully completed two Phase 3 trials (ORCA-2 and ORCA-3) and a Phase 2 trial (ORCA-V1) for e-cigarette cessation. Cytisinicline has demonstrated a strong safety profile and statistical significance in increasing the likelihood of quitting nicotine compared to placebo.
In February 2024, Achieve announced a substantial $124.2 million financing, enabling the company to further its clinical development, particularly the long-term exposure trial (ORCA-OL), which is critical for its New Drug Application (NDA) submission anticipated in the first half of 2025. This financing also involves participation from strategic investors such as Propel Bio Partners LLC, Nantahala Capital, and Sopharma, among others.
The company recently announced positive outcomes from its Phase 2 ORCA-V1 trial, where cytisinicline more than doubled the odds of quitting e-cigarettes compared to placebo. These results were published in the Journal of the American Medical Association (JAMA) Internal Medicine, further cementing cytisinicline's potential as a breakthrough treatment in nicotine cessation.
Achieve Life Sciences collaborates with key industry stakeholders and regulatory bodies like the U.S. Food and Drug Administration (FDA) to ensure the comprehensive evaluation of cytisinicline's efficacy and safety. The company is on track to begin the ORCA-OL trial in the second quarter of 2024, with results expected to support its NDA submission and potential FDA approval by 2025.
As of March 31, 2024, the company reported cash and cash equivalents totaling $66.4 million, reflecting its strong financial position post the recent equity financing. Achieve Life Sciences remains committed to its mission of providing effective treatment solutions for nicotine addiction and improving public health outcomes globally.
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.
Achieve Life Sciences (Nasdaq: ACHV) announced Dr. Cindy Jacobs' presentation at the FDA and NIH Joint Public Meeting on advancing smoking cessation treatments. Dr. Jacobs highlighted cytisinicline, the only nicotine dependence treatment currently in late-stage development. The company has completed two Phase 3 trials involving over 1,600 subjects, demonstrating safety and efficacy. The new formulation features a streamlined dosing schedule and extended treatment durations, improving upon the complex 25-day regimen of the original cytisine treatment used in Eastern and Central Europe. Achieve is working on completing a longer-term safety exposure study before NDA filing.
Achieve Life Sciences, Inc. (Nasdaq: ACHV) has promoted Jaime Xinos to Chief Commercial Officer, effective immediately. In her expanded role, Ms. Xinos will oversee all commercial operations and lead the company's strategic preparations for the anticipated U.S. launch of cytisinicline, a treatment for nicotine dependence. Her responsibilities include driving readiness across key stakeholders, including patients, healthcare providers, and payors.
Ms. Xinos, who has been with Achieve since 2017, will focus on developing innovative, patient-first, digital strategies and forging strategic partnerships to ensure a successful market entry for cytisinicline upon FDA approval. With nearly 25 years of commercial experience in the biotechnology and pharmaceutical industries, Ms. Xinos is recognized as an inspirational thought leader in translating scientific advancements into business strategies.
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