Why Did Achieve Life Sciences Inc. (ACHV) Soar 10.03%?

On August 22, 2025, Achieve Life Sciences Inc. (ACHV) surged 10.03% in pre-market trading, marking a significant rise in its stock price.

Achieve Life Sciences is on the brink of a pivotal moment as it seeks FDA approval for cytisinicline, a potential first new smoking cessation therapy in nearly two decades. The company submitted a New Drug Application (NDA) to the FDA in June, supported by positive results from two Phase 3 trials, ORCA-2 and ORCA-3, which demonstrated significantly greater abstinence rates compared to placebo.

Analysts have expressed confidence in Achieve Life Sciences' pipeline, with HC Wainwright initiating coverage with a Buy rating and a $12 price forecast. The company recently raised around $45 million to fund the continued advancement of cytisinicline, providing runway into the second half of 2026. Analyst Brandon Folkes views the next 12 to 18 months as a period of potential significant value inflection for ACHV stock, citing the strong NDA data and the sizable market opportunity.

Cytisinicline's differentiated profile, flexible dosing, and broad adoption potential position it well in a $13 billion global market. The company's valuation is seen as undervaluing the commercial potential of cytisinicline, given the shortcomings of current therapies and rising smoking and vaping rates. Achieve Life Sciences' focus on smoking health and nicotine dependence positions it for a high-stakes commercial launch in 2026, should the FDA approve cytisinicline.