SEATTLE and VANCOUVER, British Columbia, July 31, 2024 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (NASDAQ:ACHV), a late-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine dependence, announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for cytisinicline for nicotine e-cigarette, or vaping, cessation. "Since there are no FDA-approved medications specifically in ...

SEATTLE and VANCOUVER, British Columbia, July 29, 2024 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine dependence, today announced that it has entered into a $20 million debt refinancing agreement with Silicon Valley Bank (SVB), a division of First-Citizens Bank. The new loan agreement refinances the existing debt facility with SVB and SVB Capital ...

SEATTLE and VANCOUVER, British Columbia, July 25, 2024 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine dependence, today announced it will report its second quarter 2024 financial results and provide an update on the cytisinicline development program on Tuesday, August 13, 2024, at 4:30 PM EDT. To access the webcast, please use the following link: ...

SEATTLE and VANCOUVER, British Columbia, July 09, 2024 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine dependence, today announced that Achieve management will be attending the JonesHealthcare Seaside Summit 2024 being held July 14-16, 2024, in Encinitas, CA. John Bencich, CEO of Achieve, will present on Monday, July 15, 2024, at 8:45 AM PDT. Follo ...

Core Insights - Achieve Life Sciences, Inc. announced the presentation of Phase 2 ORCA-V1 trial data for cytisinicline, which showed that treatment more than doubled the likelihood of quitting vaping compared to placebo [1][2]. Company Overview - Achieve Life Sciences is focused on the global development and commercialization of cytisinicline for smoking cessation and nicotine dependence [1][4]. - The company aims to address the smoking health crisis, with an estimated 28 million adults in the U.S. smoking combustible cigarettes and over 11 million using e-cigarettes [4]. Clinical Trial Details - The ORCA-V1 trial involved 160 daily e-cigarette users across five clinical trial locations in the U.S. Participants received 3 mg of cytisinicline three times daily or a placebo for 12 weeks, alongside standard cessation behavioral support [3]. - The trial was supported by the National Institute on Drug Abuse (NIDA) with grant funding totaling $2.8 million [3]. Product Information - Cytisinicline is a plant-based alkaloid that interacts with nicotinic acetylcholine receptors in the brain, potentially reducing withdrawal symptoms and the satisfaction associated with nicotine products [5]. - Currently, there are no FDA-approved treatments specifically for nicotine e-cigarette cessation, highlighting a significant market opportunity for cytisinicline [4].

Achieve Life Sciences, Inc. (NASDAQ:ACHV) Q1 2024 Earnings Conference Call May 9, 2024 4:30 PM ET Company Participants Nicole Jones - Investor Relations John Bencich - Chief Executive Officer Cindy Jacobs - President and Chief Medical Officer Jerry Wan - Principal Accounting Officer Conference Call Participants Thomas Flaten - Lake Street Capital Michael Higgins - Ladenburg Thalmann John Vandermosten - Zacks Ilya Zubkov - Freedom Broker Operator Greetings. Welcome to Achieve Life Sciences’ First Quarter 202 ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED March 31, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM ______________ TO ____________. Commission file number 033-80623 Achieve Life Sciences, Inc. (Exact Name of Registrant as Specified in Its Charter) Delaware 95-4343413 (S ...

Exhibit 99.1 Achieve Life Sciences Reports Financial Results for First Quarter 2024 and Provides Corporate Update Company to host conference call at 4:30 PM EDT today, Thursday, May 9, 2024 SEATTLE, Wash and VANCOUVER, British Columbia, May 9, 2024 (GLOBE NEWSWIRE) Achieve Life Sciences, Inc. (NASDAQ: ACHV), a late-stage pharmaceutical company dedicated to the global development and commercialization of cytisinicline for smoking cessation and nicotine dependence, today announced its financial results for th ...

Phase 2 ORCA-V1 trial showed treatment with cytisinicline more than doubled odds of quitting e-cigarettes compared with placebo   Cytisinicline treatment well tolerated with no serious adverse events reported and excellent compliance to study treatment Achieve expects to conduct an End-of-Phase 2 Meeting with the FDA later this year to discuss Phase 3 trial plans SEATTLE and VANCOUVER, British Columbia, May 06, 2024 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (NASDAQ:ACHV), a late-stage pharmaceutical c ...

Phira Phonruewiangphing/iStock via Getty Images Achieve Life Sciences (NASDAQ:ACHV) went public via a shell company in 2017 to commercialize the smoking cessation drug Cytisinicline. Cytisinicline is derived from a plant-based compound and has a long history of use in Eastern Europe, but had not been tested in the U.S. Achieve’s central task is to usher the drug through clinical trials and the FDA approval process. Phase 3 trials are done. The company must complete a long-term safety trial before submit ...