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), 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.
Achieve Life Sciences (Nasdaq: ACHV) reported its Q3 2021 financial results, revealing a net loss of $6.7 million for the quarter. The company updated on its ORCA-2 Phase 3 trial, with all 810 subjects having completed treatment, and topline data expected in early 2022. The FDA accepted an IND application for cytisinicline in e-cigarette cessation, with a planned trial (ORCA-V1) to start around Q2 2022. Achieve also received two patents for a novel 3.0 mg TID dosing regimen, expiring in 2040, and expanded its clinical operations team.
Achieve Life Sciences (Nasdaq: ACHV) has announced that its management will hold one-on-one investor meetings at two upcoming conferences in November 2021. The first is at the A.G.P. Biotech & Specialty Pharma Conference on November 10, followed by the Torrey Hills Capital Emerging Growth Conference on November 17. Achieve focuses on developing cytisinicline, a plant-based alkaloid for smoking cessation, which is currently in the Phase 3 ORCA-2 trial, with results expected in the first half of 2022. Cytisinicline has not yet received FDA approval.
Achieve Life Sciences (Nasdaq: ACHV) announced FDA acceptance of an IND application for cytisinicline, targeting e-cigarette cessation treatments. This follows the ongoing Phase 3 trial for combustible cigarette cessation. The ORCA-V1 study, set to begin in Q2 2022, will include 150 adult e-cigarette users, supported by a grant from NIH's NIDA. Recent CDC data shows nearly 11 million adult e-cigarette users in the U.S., with a significant intent to quit. The company also anticipates topline results from its Phase 3 ORCA-2 trial in H1 2022.
Achieve Life Sciences, Inc. (Nasdaq: ACHV) will report its third-quarter 2021 financial results and provide an update on cytisinicline's development on November 9, 2021, at 4:30 PM EST. Cytisinicline targets smoking cessation and nicotine addiction. Tobacco use results in over eight million deaths globally annually. Achieve's cytisinicline interacts with nicotinic receptors to alleviate withdrawal symptoms and reduce the satisfaction of smoking. The company has completed enrollment in the Phase 3 ORCA-2 trial, with topline results expected in early 2022.
Achieve Life Sciences (NASDAQ: ACHV) announced CEO John Bencich's participation in two investor conferences. He will present at the Oppenheimer Fall Healthcare Life Sciences & MedTech Summit on September 21, 2021, at 3:45 PM ET and join the Maxim Group's Advances in Mental Health Virtual Conference on the 'Addiction' panel on September 22, 2021, at 9:00 AM ET. Cytisinicline, the company's focus, is a treatment for nicotine addiction, with Phase 3 ORCA-2 trial results expected in the first half of 2022.
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