Achieve Life Sciences (NASDAQ:ACHV) reached a new 52-week high of $7.60 on Wednesday. The stock closed the session at $7.52.
Investor confidence is growing in cytisinicline, a plant-based alkaloid for smoking cessation and nicotine dependence. The company recently secured financing to fund Phase 3 trials and commercialization. Achieve also strengthened its leadership team and board of directors.
The FDA issued a Complete Response Letter in June regarding manufacturing facility issues. The agency cited no deficiencies regarding the drug's efficacy or safety. Achieve plans to resubmit its New Drug Application in the fourth quarter of 2026.