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) 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.
Achieve Life Sciences (NASDAQ: ACHV) has announced that data on cytisinicline will be presented at the Society for Research on Nicotine & Tobacco (SRNT-E) Conference from September 15-17, 2021. Key presentations include a subgroup analysis from the ORCA-1 Phase 2 study, showing a Week 4 abstinence rate of 51.3% for cytisinicline, significantly higher than the 15.8% rate for placebo (p=0.009). Another analysis highlighted a shorter time to sustained abstinence with cytisinicline, taking only 7 days compared to 18 days for placebo. Achieve's enrollment in the Phase 3 ORCA-2 trial has been completed, with results expected in early 2022.
Achieve Life Sciences (NASDAQ: ACHV) announced CEO John Bencich's participation in two upcoming investor conferences. The first is a virtual corporate overview at the HC Wainwright 23rd Annual Global Investment Conference on September 13, 2021. The second event is the Lake Street Capital Markets' 5th Annual Best Ideas Growth Conference on September 14-15, 2021, featuring virtual one-on-one investor meetings. Additionally, Achieve recently completed enrollment in the Phase 3 ORCA-2 clinical trial for cytisinicline, with results anticipated in early 2022.
Achieve Life Sciences, Inc. (NASDAQ: ACHV) recently expanded its clinical operations team with key hires, including a Director of Clinical Operations and a Senior Manager of Clinical Trials. This move aims to enhance the development of cytisnicline, a potential treatment for smoking cessation. Achieve has fully enrolled its Phase 3 ORCA-2 trial, targeting combustible cigarette cessation, with results expected in H1 2022. Additionally, the Board approved stock options for new employees, incentivizing their contributions. The firm is committed to addressing nicotine addiction, a major public health issue.
Achieve Life Sciences (ACHV) announced its Q2 2021 financial results, including a net loss of $11.3 million. The company reported the completion of enrollment for the Phase 3 ORCA-2 trial of cytisinicline, involving 810 adult smokers. Achieve secured a $23 million financing and received a NIH grant to evaluate cytisinicline for e-cigarette cessation. Additionally, two new patents were issued for the 3.0 mg TID dosing regimen. Topline data from the ORCA-2 trial is expected in H1 2022.
Achieve Life Sciences (NASDAQ:ACHV) announced the issuance of two patents by the USPTO for a 3.0 mg TID dosing regimen of cytisinicline, a treatment for nicotine addiction. The patents could provide marketing exclusivity until 2040, enhancing the company’s position in the smoking cessation market. Results from the ongoing Phase 3 ORCA-2 trial are expected in early 2022.
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