GlobeNewswire·Nov 10, 2026, 8:00 AM ET

AchieveRx Reports Third Quarter 2026 Financial Results and Provides Business Updates

ACHV QUIT

Achieve Life Sciences, Inc. rebranded as AchieveRx, The Quit Company, with Nasdaq trading symbol changed to "QUIT".
The company presented 52-week ORCA-OL trial data at the CHEST 2026 Annual Meeting showing 31.2% of participants achieved four-week continuous abstinence by the end of treatment.
Cytisinicline demonstrated sustained efficacy in a hard-to-treat population with a median of five prior quit attempts, with quit rates rising from 25.5% to 31.2% over the year.
The drug was generally well tolerated over 52 weeks with no new safety signals identified by the Data Safety Monitoring Committee.
Three commercial-scale stability batches for U.S.-based finished drug product manufacturing were completed at Adare Pharma Solutions.
The New Drug Application (NDA) resubmission remains on track for the fourth quarter of 2026, with potential FDA approval anticipated by the end of Q2 2027.
Two senior leadership appointments were made: Ben Halladay as Chief Financial Officer & Kaitlyn Tuson as Senior Vice President, Marketing and Communications.
Cash, cash equivalents, & marketable securities totaled $201.5 million as of September 30, 2026, an increase from $187.3 million in June 2026.
Total operating expenses were $20.5 million for the three months ended September 30, 2026, with a net loss of $12.1 million.
Total operating expenses for the nine months ended September 30, 2026, were $49.4 million, with a net loss of $97.0 million.
The net loss for the quarter included a non-cash gain of $6.9 million related to changes in fair value of warrant liabilities.

Company: Achieve Life Sciences, Inc.
Keywords: Nasdaq:ACHV, Achieve Life Sciences, Inc.