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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) announced plans to report its fourth quarter and year-end 2022 financial results on March 16, 2023, at 4:30 PM EDT. The update will include progress on cytisinicline, a candidate aimed at addressing nicotine addiction primarily from smoking and e-cigarette use. Despite its potential, cytisinicline is still under investigation and not FDA-approved. The press release highlights the serious health implications of smoking and the growing concern around e-cigarette usage among youth, indicating a pressing market need for effective cessation solutions.
Achieve Life Sciences has completed treatment for the final subject in its Phase 2 ORCA-V1 trial, evaluating the efficacy of cytisinicline for nicotine e-cigarette cessation. The trial involved 160 adult participants randomized to receive either cytisinicline or placebo over 12 weeks, with standardized behavioral support. Topline results are expected in Q2 2023. Currently, no FDA-approved treatments target e-cigarette cessation, positioning cytisinicline with significant market potential. The study is funded by the National Institute on Drug Abuse. The primary endpoint focuses on continuous abstinence in the last four weeks of treatment.
Achieve Life Sciences (NASDAQ: ACHV) announced its participation in one-on-one meetings during the 2023 SVB Securities Global Biopharma Conference, occurring virtually from February 14-16, 2023. The company focuses on the development of cytisinicline for smoking cessation and nicotine addiction, addressing a significant public health crisis that results in over eight million deaths globally each year. Cytisinicline is a plant-based alkaloid that interacts with nicotine receptors, potentially aiding in the treatment of nicotine addiction. It's important to note that this investigational treatment is not yet FDA-approved.
Achieve Life Sciences (Nasdaq: ACHV) announced an inducement grant of stock options to a new employee, approved by the Board of Directors on January 25, 2023. The grant includes options to purchase 15,000 shares of common stock, serving as a material inducement for the employee's hiring, as per Nasdaq Listing Rule 5635(c)(4). The options will vest over four years, with 25% vesting at the one-year mark, and the remainder vesting monthly, contingent on continued employment. The options will have a 10-year term and an exercise price equal to the stock’s closing price on the grant date.
Achieve focuses on developing cytisinicline for smoking cessation, aimed at addressing the global nicotine addiction epidemic.
Achieve Life Sciences (NASDAQ: ACHV) announced the completion of treatment for the final subject in its Phase 3 ORCA-3 trial, which evaluates the effectiveness of cytisinicline for smoking cessation. The trial involved 792 subjects and will compare the drug's efficacy against a placebo. Achieve anticipates releasing data results in Q2 2023. If approved, cytisinicline would be the first non-nicotine prescription smoking cessation treatment in the U.S. in nearly two decades. The company is also moving forward with preparations for an FDA filing.
Achieve Life Sciences announced that the USPTO issued U.S. Patent No. 11,459,328 for the mesylate salt formulation of cytisinicline. This patent expands their portfolio, now totaling 18 patents, securing exclusivity until 2040 for its effective 3.0 mg dosing regimen. Achieve is conducting Phase 3 trials (ORCA-3) for smoking cessation and Phase 2 trials (ORCA-V1) for e-cigarette cessation, with topline data expected in Q2 2023. Cytisinicline, a plant-based alkaloid, targets nicotine dependence and has shown promise in clinical settings.
Achieve Life Sciences announced a private placement of securities, raising approximately $18.9 million to support the development of cytisinicline for smoking cessation. The placement consists of 4,093,141 units at $4.625 per unit, with an 8.6% premium over the previous closing price. Proceeds will fund clinical research and working capital, estimated to maintain operations into late 2023. The placement is led by Lake Street Capital Markets, ensuring investment from both new and existing investors.
Achieve Life Sciences (NASDAQ: ACHV) reported its third quarter 2022 financial results on November 14, announcing the completion of targeted enrollment in key clinical trials for cytisinicline, a smoking cessation treatment. The Phase 3 ORCA-3 trial enrolled 750 adult smokers, while the Phase 2 ORCA-V1 trial for e-cigarette users completed early enrollment with 150 participants. Financially, the company recorded a net loss of $13.1 million for Q3 and held $18.2 million in cash as of September 30, 2022. Top-line data from both trials is expected in Q2 2023.
Achieve Life Sciences has successfully reached target enrollment for the Phase 2 ORCA-V1 clinical trial of cytisinicline, aimed at aiding adults dependent on nicotine vaping to quit. This randomized, placebo-controlled trial will treat 150 participants, measuring efficacy and safety over 12 weeks. Positive results from the prior ORCA-2 trial demonstrated significant quit rates among smokers. Topline results from ORCA-V1 are anticipated in the first half of 2023, supported by grant funding from the National Institute on Drug Abuse.
Achieve Life Sciences, Inc. (NASDAQ: ACHV) is set to report its third quarter financial results on November 14, 2022, at 4:30 PM EST. The announcement will provide updates on the development of cytisinicline, an investigational treatment aimed at aiding smoking cessation and nicotine dependence. Presently, there are no FDA-approved treatments for nicotine e-cigarette cessation. Achieve's efforts focus on addressing the global nicotine addiction epidemic, which contributes to over 8 million deaths annually worldwide due to tobacco use.
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