Achieve Life Sciences, Inc. - ACHV STOCK NEWS

Achieve Life Sciences (NASDAQ: ACHV) announced its participation in one-on-one meetings during the 2023 SVB Securities Global Biopharma Conference, occurring virtually from February 14-16, 2023. The company focuses on the development of cytisinicline for smoking cessation and nicotine addiction, addressing a significant public health crisis that results in over eight million deaths globally each year. Cytisinicline is a plant-based alkaloid that interacts with nicotine receptors, potentially aiding in the treatment of nicotine addiction. It's important to note that this investigational treatment is not yet FDA-approved.

Achieve Life Sciences (Nasdaq: ACHV) announced an inducement grant of stock options to a new employee, approved by the Board of Directors on January 25, 2023. The grant includes options to purchase 15,000 shares of common stock, serving as a material inducement for the employee's hiring, as per Nasdaq Listing Rule 5635(c)(4). The options will vest over four years, with 25% vesting at the one-year mark, and the remainder vesting monthly, contingent on continued employment. The options will have a 10-year term and an exercise price equal to the stock’s closing price on the grant date.

Achieve focuses on developing cytisinicline for smoking cessation, aimed at addressing the global nicotine addiction epidemic.

Achieve Life Sciences (NASDAQ: ACHV) announced the completion of treatment for the final subject in its Phase 3 ORCA-3 trial, which evaluates the effectiveness of cytisinicline for smoking cessation. The trial involved 792 subjects and will compare the drug's efficacy against a placebo. Achieve anticipates releasing data results in Q2 2023. If approved, cytisinicline would be the first non-nicotine prescription smoking cessation treatment in the U.S. in nearly two decades. The company is also moving forward with preparations for an FDA filing.

Achieve Life Sciences announced that the USPTO issued U.S. Patent No. 11,459,328 for the mesylate salt formulation of cytisinicline. This patent expands their portfolio, now totaling 18 patents, securing exclusivity until 2040 for its effective 3.0 mg dosing regimen. Achieve is conducting Phase 3 trials (ORCA-3) for smoking cessation and Phase 2 trials (ORCA-V1) for e-cigarette cessation, with topline data expected in Q2 2023. Cytisinicline, a plant-based alkaloid, targets nicotine dependence and has shown promise in clinical settings.

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.