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) announced its participation in the Oppenheimer 32nd Annual Virtual Healthcare Conference on March 15, 2022, at 2:00 PM EDT, and the Maxim 2022 Virtual Growth Conference on March 28, 2022, at 2:30 PM EDT. The company is focused on developing cytisinicline, a plant-based alkaloid aimed at aiding smoking cessation and addressing nicotine addiction. Cytisinicline is not FDA approved for any indication in the U.S. The press release also mentioned the significant global health risks of tobacco use and the potential market for effective cessation therapies.
Achieve Life Sciences (Nasdaq: ACHV) will report its fourth quarter and year-end 2021 financial results on March 10, 2022, at 4:30 PM EST, and provide updates on its cytisinicline development program. Cytisinicline aims to address smoking addiction, a leading cause of preventable deaths globally. It interacts with nicotine receptors in the brain, potentially aiding smoking cessation. Notably, cytisinicline is still investigational and not yet FDA approved. Investors can access the call via the Achieve website or by dialing provided numbers.
Achieve Life Sciences (Nasdaq: ACHV) has expanded its Clinical Operations Team with the hire of a new Director of Clinical Operations, as announced on February 3, 2022. To incentivize this recruitment, the Board of Directors approved a stock option grant of 15,000 shares with a per share exercise price equal to the closing price on January 31, 2022. Additionally, the company has completed enrollment in the Phase 3 ORCA-2 clinical trial for cytisinicline, targeting smoking cessation, with topline results expected in the first half of 2022.
Achieve Life Sciences (NASDAQ: ACHV) is participating in the Winter Wonderland Best Ideas Virtual Investor Conference on February 8, 2022, at 2:00 PM EST and the Aegis Virtual Conference on February 25, 2022, also at 2:00 PM EST. The company focuses on developing cytisinicline, a plant-based treatment aimed at smoking cessation and nicotine addiction. Tobacco use is a leading cause of preventable deaths worldwide. Cytisinicline is an investigational product candidate and has yet to receive FDA approval for any use in the U.S. For more details, visit Achieve's website.
Achieve Life Sciences (ACHV) has announced the initiation of screening for the ORCA-3 trial, a crucial Phase 3 study aimed at securing U.S. regulatory approval for cytisinicline, a drug intended for smoking cessation. The trial will assess the safety and efficacy of 3 mg doses administered three times daily, with 750 adult smokers participating across 15 sites. This trial follows the ORCA-2 study, with topline results expected soon. Achieve anticipates significant developments in 2022, including the launch of the ORCA-V1 trial focused on e-cigarette cessation.
Achieve Life Sciences (Nasdaq: ACHV), a clinical-stage pharmaceutical company focused on cytisinicline for smoking cessation, announced that CEO John Bencich will present at the H.C. Wainwright BIOCONNECT Virtual Conference from January 10-13, 2022. The presentation is scheduled for January 10 at 7:00 am ET. Investors can register for the conference online. Cytisinicline is an investigational drug aimed at treating nicotine addiction, showing potential in reducing withdrawal symptoms and cravings. It is not yet FDA approved.
Achieve Life Sciences announced the completion of the follow-up phase for the ORCA-2 Phase 3 trial, which evaluated the effectiveness of cytisinicline for smoking cessation. The trial involved 810 participants across 17 clinical sites in the U.S. and is part of Achieve's ongoing commitment to combat nicotine addiction. Topline results are expected in Q2 2022, with plans to initiate the ORCA-3 and ORCA-V1 trials later in the year. Cytisinicline is an investigational treatment that targets nicotine withdrawal symptoms and has yet to receive FDA approval.
Achieve Life Sciences (Nasdaq: ACHV) announced a $25 million debt agreement with Silicon Valley Bank and SVB Innovation Credit Fund VIII. The agreement includes $15 million in convertible debt and an option for an additional $10 million in loans. The funds will support the completion of the cytisinicline smoking cessation clinical development program, particularly the ORCA-3 Phase 3 clinical trial. The debt matures on December 22, 2023, at a floating interest rate, with significant conditions regarding conversion into shares. More information is available in the company's Form 8-K filing.
Achieve Life Sciences (Nasdaq: ACHV) will host a Key Opinion Leader virtual panel on smoking and e-cigarette cessation on December 2, 2021, at 1:00 PM EST. The event, moderated by Thomas Flaten of Lake Street Capital Markets, will feature experts Nancy Rigotti and Neal Benowitz discussing the critical importance of nicotine cessation. Achieve is focused on developing cytisinicline to help combat smoking addiction, which accounts for over 8 million deaths annually. Cytisinicline aims to reduce withdrawal symptoms and the satisfaction associated with smoking.
Achieve Life Sciences has announced the completion of the fifth and final review by the Data Safety Monitoring Committee (DSMC) for its Phase 3 ORCA-2 trial assessing cytisinicline for smoking cessation. The DSMC found no concerns regarding the safety or conduct of the trial, which involved 810 participants across 17 sites. Preliminary data is expected in the first half of 2022, with an emphasis on the potential safety and tolerability of cytisinicline as differentiating factors compared to existing treatments.
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