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.
FAQ
What is the current stock price of Achieve Life Sciences (ACHV)?
What is the market cap of Achieve Life Sciences (ACHV)?
What is the main focus of Achieve Life Sciences?
What is cytisinicline?
What recent clinical trials has Achieve Life Sciences completed?
What were the results of the Phase 2 ORCA-V1 trial?
What is the purpose of the ORCA-OL trial?
How is Achieve Life Sciences funded?
When does Achieve Life Sciences plan to submit the NDA for cytisinicline?
Who are the key investors in the recent financing round for Achieve Life Sciences?
What is the current financial status of Achieve Life Sciences?
What are the next steps for cytisinicline's development?
