New Smoking Cessation Treatment Targets Bio, 470 Billion Won Fundraising and CEO Change

Achieve Life Sciences, Inc. (NASDAQ: ACHV) reported its first-quarter 2026 results, securing a private placement of up to $354 million (approximately KRW 470 billion) and revamping its leadership and board by appointing Andrew D. Goldberg, MD, as President, Chief Executive Officer and director.

The company disclosed that its former contract manufacturing organization received an “Official Action Indicated” (OAI) classification from the U.S. Food and Drug Administration (FDA) for cGMP-related findings. As it transitions commercial production of cytisinicline to U.S.-based Adare Pharma Solutions, Achieve expects to receive a complete response letter (CRL) for its cytisinicline New Drug Application (NDA) around the June 20, 2026 PDUFA date. The company plans to resubmit the NDA in Q4 2026—naming Adare as the primary manufacturer—and is targeting a U.S. commercial launch in H1 2027.

As of March 31, 2026, Achieve held $29.3 million in cash and short-term investments. The company recorded operating expenses of $10.5 million and a net loss of $10.2 million for the quarter.

Achieve’s NDA for cytisinicline in smoking cessation was officially accepted by the FDA in September 2025, with a PDUFA target date of June 20, 2026. In April 2026, the company announced the complete transfer of finished-product manufacturing to Adare’s Vandalia, Ohio, facility—underscoring its commitment to onshore production and supply-chain risk mitigation.

A late-stage specialty pharmaceutical company, Achieve Life Sciences focuses on a single-asset pipeline for nicotine-dependence treatment using cytisinicline to support cessation of smoking and e-cigarette use. If approved, cytisinicline would be the first new smoking cessation drug in nearly 20 years, positioning it as a potential leading option alongside existing therapies in the global smoking-cessation and addiction-treatment market.