Business
Achieve Life Sciences Reports Financial Results for Second Quarter 2024 and Provides Corporate Update
Company to host conference call at 4:30 PM EDT today, Tuesday, August 13, 2024 SEATTLE and VANCOUVER, British Columbia, Aug. 13, 2024 (GLOBE NEWSWIRE) --
About this update from Achieve Life Sciences, Inc.
[{"type":"text","content":"Company to host conference call at 4:30 PM EDT today, Tuesday, August 13, 2024\nSEATTLE and VANCOUVER, British Columbia, Aug. 13, 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 the second quarter of 2024 and provided an update on its cytisinicline development program. Recent Highlights The FDA granted Breakthrough Therapy designation for cytisinicline treatment of nicotine e-cigarette, or vaping, cessationCompleted refinancing and extended the maturity date of outstanding term loans with Silicon Valley Bank (SVB)Joined the U.S. Russell 3000® and Russell Microcap® IndexesInitiated ORCA-OL clinical trial evaluating long-term exposure of cytisinicline in people who smoke or use nicotine e-cigarettesPresented data from cytisinicline ORCA-V1 program at Society of General Internal Medicine (SGIM) Annual Meeting “We are extremely proud of the significant milestones we have accomplished over the last few months, including the granting of Breakthrough Therapy designation for cytisinicline for vaping cessation, which highlights the urgent need for an effective treatment to help the millions of people who are battling nicotine vape addiction,” stated John Bencich, Chief Executive Officer of Achieve. “Additionally, we initiated and are making great progress in the ORCA-OL trial evaluating long-term cytisinicline exposure moving us closer to our expected NDA filing in the first half of 2025.” Cytisinicline for Vaping Cessation Granted FDA Breakthrough Therapy DesignationThe U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for cytisinicline for nicotine e-cigarette, or vaping, cessation. The designation aims to accelerate the development and review process for promising drugs that are intended to treat serious conditions and when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapies. There are currently no FDA-approved treatments specifically indicated for vaping cessation. Achieve plans to hold an End-of-Phase 2 meeting with the FDA’s multidisciplinary team under this Breakthrough Therapy designation before the end of the ye...