Gary Nachman

John Vandermosten

Justin Walsh

Boris Tolkachev

Thomas Flaten

François Brisebois

Brandon Folkes

- Achieve Life Sciences (ACHV) has been awarded a **Commissioner's National Priority Voucher (CNPV)** by the FDA for cytisinicline, intended for the treatment of nicotine dependence for e-cigarette or vaping cessation.  **[949858_fbc7fd1dfcce4bc69336340cbd3e653d_0]** 
- This designation provides an **expedited FDA review pathway**, reducing the assessment time to **one to two months** from the standard 10-12 months.  **[949858_fbc7fd1dfcce4bc69336340cbd3e653d_0]** 
- Cytisinicline is a potential first-in-class treatment addressing a significant unmet medical need, with approximately **17 million adult e-cigarette users** in the U.S., 60% of whom desire to quit.  **[949858_fbc7fd1dfcce4bc69336340cbd3e653d_0]** 
- Separately, the FDA accepted Achieve Life Sciences' New Drug Application (NDA) for cytisinicline for **smoking cessation**, with a Prescription Drug User Fee Act (PDUFA) target action date of **June 20, 2026**.  **[949858_fbc7fd1dfcce4bc69336340cbd3e653d_1]**

Achieve Life Sciences Receives FDA Commissioner's National Priority Voucher

- Achieve Life Sciences announced a **leadership transition**, with Dr. Cindy Jacobs resigning as Chief Medical Officer and President, effective **October 6, 2025**, and Dr. Mark Rubinstein appointed Interim Chief Medical Officer.  **[949858_4c004837efda4e17a39893cf2f149511]** 
- The company recently received **FDA acceptance** of its New Drug Application for cytisinicline, a plant-based treatment for nicotine dependence, and is progressing toward commercialization.  **[949858_4c004837efda4e17a39893cf2f149511]** 
- Achieve Life Sciences faces financial challenges typical of early-stage biotechs, including **zero revenue** and **ongoing losses**, with a **negative earnings per share of -1.46**.  **[949858_4c004837efda4e17a39893cf2f149511]** 
- The stock (ACHV) has an analyst rating of **'Buy'** with a **$10.00 price target**, although TipRanks’ AI Analyst rates it as **'Underperform'**.  **[949858_4c004837efda4e17a39893cf2f149511]**

ACHIEVE LIFE SCIENCES (ACHV)