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 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.
Achieve Life Sciences has successfully completed enrollment for 750 participants in its Phase 3 ORCA-3 trial, evaluating the efficacy and safety of cytisinicline in smoking cessation among adult smokers in the U.S. The trial compares 3 mg cytisinicline dosed three times daily against placebo over 6 or 12 weeks. Topline results are expected in the first half of 2023. If successful, this could lead to FDA approval, making it the first non-nicotine smoking cessation treatment available in almost 20 years, following positive results from the earlier ORCA-2 trial.
Achieve Life Sciences (NASDAQ: ACHV) announced participation in the Lake Street Best Ideas Growth Conference and the Ladenburg Thalmann Healthcare Conference, aimed at promoting cytisinicline, a treatment for smoking cessation. The Lake Street conference is set for September 14, 2022, featuring one-on-one meetings, while the Ladenburg Thalmann conference will include a presentation on September 29, 2022. Achieve's cytisinicline targets nicotine addiction amid rising e-cigarette use and smoking-related health risks, with the drug currently under investigation.
Achieve Life Sciences (ACHV) announced its Q2 2022 financial results, highlighting significant milestones in its clinical program for cytisinicline.
The Phase 3 ORCA-2 trial showed statistically significant results with increased quit rates, 6-8 times higher than placebo. The company was also awarded a $2.5 million NIH grant for the ORCA-V1 Phase 2 trial targeting nicotine e-cigarette users. Financially, Achieve reported a net loss of $10.5 million for Q2, with cash reserves of $29.4 million as of June 30, 2022. A conference call is scheduled for August 11, 2022, at 4:30 PM EDT.
Achieve Life Sciences (NASDAQ: ACHV) will release its second quarter financial results on August 11, 2022, at 4:30 PM EDT. The focus will be on the development of cytisinicline, a plant-based treatment for smoking cessation. Tobacco-related diseases result in over 8 million deaths globally each year. Cytisinicline aims to address nicotine addiction by acting on brain receptors to ease withdrawal symptoms and reduce cravings. The product is still under investigation and has not yet received FDA approval.
Achieve Life Sciences (Nasdaq: ACHV) announced the issuance of stock options to two new employees as inducement grants. The Board approved a total of 15,000 shares for purchase on June 29, 2022. This action aligns with Nasdaq Listing Rule 5635(c)(4), emphasizing the company's commitment to attracting talent. The options will vest over four years, starting with 25% after the first year of employment. Achieve focuses on developing cytisinicline for smoking cessation, targeting a significant public health issue amid the global nicotine addiction epidemic.
Achieve Life Sciences (Nasdaq: ACHV) has initiated subject screening for its ORCA-V1 Phase 2 clinical trial, testing 3mg cytisinicline in 150 adult e-cigarette users across five U.S. locations. Funded by a $2.8 million grant from the National Institute on Drug Abuse, the trial will assess efficacy versus placebo over 12 weeks. The ORCA-2 trial previously yielded positive results, showing up to eight times higher quit rates for smokers using cytisinicline compared to placebo. Achieve is also advancing its Phase 3 ORCA-3 trial targeting combustible cigarette cessation.
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?
