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.
Overview of Achieve Life Sciences Inc
Achieve Life Sciences Inc is a specialty pharmaceutical company with a core focus on the development and commercialization of cytisinicline, a plant-based alkaloid that targets nicotine addiction through its use as a smoking cessation aid. As a company operating in the highly specialized field of pharmaceutical innovation, Achieve employs rigorous clinical research protocols, evidence-based strategies, and robust safety monitoring to address one of the major public health challenges of modern times.
Business Focus and Clinical Development
At the heart of Achieve’s mission is its commitment to transforming the treatment paradigm for nicotine dependence. The company focuses on the advancement of cytisinicline, leveraging a series of clinical trials to validate its safety and efficacy. By incorporating established protocols as well as innovative dosing regimens, Achieve aims to provide a streamlined treatment option that reduces withdrawal symptoms and decreases the reward associated with nicotine consumption. This scientific approach reinforces the company’s commitment to clinical excellence and safety.
Scientific Rigor and Industry Expertise
Achieve Life Sciences distinguishes itself by integrating industry-standard best practices with a focused research agenda. Through multiple phases of clinical trials, including controlled Phase 2 and Phase 3 studies, the company has generated significant clinical data supporting the potential of cytisinicline. Each study is meticulously designed to meet regulatory standards and to gather long-term safety data, underscoring the company’s dedication to evidence-based medicine.
Addressing a Global Public Health Need
The global epidemic of nicotine addiction, fueled by both cigarette smoking and e-cigarette use, is a critical public health concern. With millions of individuals affected worldwide, the need for effective treatments has never been more urgent. Achieve Life Sciences is uniquely positioned in the competitive landscape, leveraging its scientific foundation and strategic clinical programs to address this need. Its focus on cytisinicline targets the biochemical pathways involved in nicotine dependence, offering a therapeutic option that is both innovative and potentially disruptive in a market that has seen little breakthrough in decades.
Operational Strategy and Market Position
Operating with a single, well-defined business segment, Achieve Life Sciences streamlines its efforts toward the development and commercialization of cytisinicline. This focused approach allows the company to allocate resources efficiently and to build deep expertise in the treatment of nicotine addiction. The strategic use of clinical data, combined with proactive regulatory engagement, positions the company favorably among both competitors and potential partners in the specialty pharmaceutical arena.
Commitment to Safety and Compliance
Safety is a fundamental pillar in the company’s operational framework. Achieve Life Sciences continuously evaluates the long-term exposure effects of cytisinicline through open-label studies designed to fulfill regulatory safety requirements. This commitment ensures that each phase of drug development is performed with the utmost care, adhering to industry best practices and reinforcing a trust-based relationship with healthcare providers, regulators, and patients.
Integrating Expertise with Patient-Centered Solutions
The company’s leadership and team of experienced professionals bring years of commercial and clinical expertise to the table. With a deep understanding of the pharmaceutical market and the complexities of addressing nicotine dependence, Achieve Life Sciences builds its strategies on a foundation of clinical innovation, operational precision, and transparent communication. The company’s efforts are aimed at providing patients with a clear, effective path to overcoming nicotine addiction.
Conclusion
Through its unwavering focus on cytisinicline and smoking cessation, Achieve Life Sciences Inc offers a unique, scientifically backed solution in the fight against nicotine addiction. Its comprehensive clinical programs, commitment to safety, and specialized therapeutic approach combine to create an information-rich narrative that underpins the company’s role in advancing public health. Investors and interested stakeholders can rely on the company’s deep industry knowledge and transparent operational practices as it continues to build expertise in a critical area of healthcare.
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.
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.
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