Achieve Life Sciences Inc Stock Price, News & Analysis

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.

Achieve Life Sciences (NASDAQ: ACHV), a clinical-stage pharmaceutical firm, will participate in the Spring Into Action Best Ideas Virtual Investor Conference from May 16-20, 2022. Achieve focuses on the development of cytisinicline, a plant-based product aimed at smoking cessation and nicotine addiction. This investigational candidate has not yet received FDA approval. With tobacco-related deaths exceeding eight million globally, cytisinicline aims to mitigate this crisis by targeting nicotine receptors in the brain. For access to the conference, registration is required.

Achieve Life Sciences (Nasdaq: ACHV) reported strong first quarter 2022 results, highlighting significant outcomes from the Phase 3 ORCA-2 trial of cytisinicline for smoking cessation. The trial showed a 32.6% abstinence rate at weeks 9-12 for those on cytisinicline, compared to 7.0% for placebo. The company gained access to an additional $10 million in funding via a revised agreement with Silicon Valley Bank. Achieve ended the quarter with $36.4 million in cash and reported a net loss of $7.6 million on operating expenses of $7.2 million.

Achieve Life Sciences (NASDAQ: ACHV) announced positive topline results from the Phase 3 ORCA-2 trial for cytisinicline, showing significant efficacy in smoking cessation. Participants receiving 12 weeks of treatment demonstrated a 6.3x higher likelihood of quitting smoking compared to placebo, while those receiving 6 weeks showed an 8x increase. Continuous abstinence rates were 21.1% and 8.9% respectively after treatment. The trial highlighted cytisinicline's safety with low adverse event rates. Achieve is seeking FDA approval for this potential breakthrough in smoking cessation therapy.

Achieve Life Sciences (Nasdaq: ACHV) will report its first quarter financial results and provide an update on its cytisinicline development program on May 12, 2022, at 4:30 PM EDT. Cytisinicline aims to assist in smoking cessation by targeting nicotine receptors in the brain, yet remains an investigational product and is not FDA-approved in the U.S. Tobacco usage leads to over eight million deaths globally each year, highlighting the importance of Achieve's mission. More details can be accessed through their webcast.

Achieve Life Sciences, Inc. (NASDAQ: ACHV) announced a presentation on cytisinicline for smoking cessation at the Society for Research on Nicotine and Tobacco (SRNT) Annual Meeting in Baltimore, MD, from March 15-18, 2022. The presentation, part of the "Promising New Smoking Cessation Pharmacotherapies" Symposium on March 16 at 3:00 p.m. EDT, aims to highlight the development program for cytisinicline. Cytisinicline is a plant-based alkaloid targeting nicotine addiction, currently in clinical trials and not yet FDA-approved.

Achieve Life Sciences (Nasdaq: ACHV) announced the appointment of Dr. Vaughn Himes to its Board of Directors, effective immediately. Dr. Himes brings over 30 years of experience in the pharmaceutical and biotech industries, currently serving as Chief Technology Officer at Seagen. His expertise will support Achieve's clinical development of cytisinicline, aimed at treating smoking cessation and nicotine addiction. Cytisinicline is a plant-based alkaloid that interacts with nicotine receptors to alleviate withdrawal symptoms, though it remains investigational and not FDA-approved.