Achieve Life Sciences Inc Stock Price, News & Analysis

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.

Achieve Life Sciences has received a $2.5 million grant from the National Institute on Drug Abuse (NIDA) to fund the initiation of the Phase 2 ORCA-V1 clinical trial. This trial will assess the efficacy and safety of cytisinicline in around 150 adult users of nicotine e-cigarettes at five locations in the U.S. The total awarded funding now amounts to $2.8 million, covering about half the trial's costs. Notably, cytisinicline has shown promising results in previous studies, and there is a significant market opportunity as over 10 million U.S. adults use e-cigarettes.

Achieve Life Sciences (NASDAQ: ACHV) is set to participate in the LD Micro Invitational Conference from June 7-9, 2022, at the Four Seasons in Westlake Village, CA. The presentation scheduled for June 7 at 7:30 AM PDT will also be available for virtual viewing. Achieve focuses on developing cytisinicline, a plant-based compound aimed at aiding smoking cessation and addressing nicotine addiction. Tobacco use causes over 8 million deaths globally each year, highlighting the significance of Achieve's mission. Cytisinicline has not yet received FDA approval.