Achieve Life Sciences, Inc. - ACHV STOCK NEWS

Achieve Life Sciences, Inc. (NASDAQ: ACHV) announced its fourth quarter and year-end 2022 financial results on March 16, 2023. The company reported a net loss of $11.2 million for Q4 and $42.4 million for the year. Achieve achieved key milestones in its cytisinicline development, including completing dosing in the Phase 2 ORCA-V1 trial and final subject dosing in the Phase 3 ORCA-3 trial, both targeting smoking cessation. The company secured $18.9 million through a private placement to fund ongoing research. A recent patent for a new cytisinicline formulation was granted by the USPTO. The company expects topline results from ongoing trials in Q2 2023.

Achieve Life Sciences (NASDAQ: ACHV) announced the completion of the last follow-up visit for subjects in the Phase 2 ORCA-V1 trial evaluating the efficacy and safety of cytisinicline for nicotine e-cigarette cessation. Conducted across 5 locations in the U.S. with 160 participants, the trial compares cytisinicline to a placebo over 12 weeks. Topline results are expected in 2Q 2023. The trial is backed by the National Institute on Drug Abuse. The primary endpoint is continuous abstinence in the last month of treatment.

Achieve Life Sciences (NASDAQ: ACHV) announced data from the Phase 3 ORCA-2 trial for cytisinicline, aimed at smoking cessation, presented at the SRNT Annual Meeting in San Antonio, TX. The trial showed a 6-8 times higher likelihood of smoking abstinence in participants taking 3mg cytisinicline three times daily over 6-12 weeks compared to placebo. Notably, successful abstinence was observed across various demographics. With 82% treatment compliance and no serious adverse events recorded, Achieve is optimistic about future FDA approval as it also prepares for forthcoming ORCA-3 and ORCA-V1 trial results expected in Q2 2023.

Achieve Life Sciences (NASDAQ: ACHV) announced plans to report its fourth quarter and year-end 2022 financial results on March 16, 2023, at 4:30 PM EDT. The update will include progress on cytisinicline, a candidate aimed at addressing nicotine addiction primarily from smoking and e-cigarette use. Despite its potential, cytisinicline is still under investigation and not FDA-approved. The press release highlights the serious health implications of smoking and the growing concern around e-cigarette usage among youth, indicating a pressing market need for effective cessation solutions.

Achieve Life Sciences has completed treatment for the final subject in its Phase 2 ORCA-V1 trial, evaluating the efficacy of cytisinicline for nicotine e-cigarette cessation. The trial involved 160 adult participants randomized to receive either cytisinicline or placebo over 12 weeks, with standardized behavioral support. Topline results are expected in Q2 2023. Currently, no FDA-approved treatments target e-cigarette cessation, positioning cytisinicline with significant market potential. The study is funded by the National Institute on Drug Abuse. The primary endpoint focuses on continuous abstinence in the last four weeks of treatment.

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.