Dec. 30 at 5:05 PM
Achieve Life Sciences shares rose after Hunterbrook Capital disclosed a long position ahead of an upcoming FDA decision. The company is awaiting FDA approval for cytisinicline, a smoking-cessation treatment, with a decision expected on June 20. If approved, Achieve plans to launch the drug in the U.S. by late 2026.
The FDA has accepted the application for review, supported by two successful Phase 3 trials and a positive long-term safety study. Achieve is also pursuing approval for cytisinicline as the first therapy to help people quit vaping, a program that has received both a Priority Review Voucher and Breakthrough Therapy designation.
Cytisinicline is already used in Europe and has shown better safety and efficacy than prior smoking-cessation drugs withdrawn from the U.S. market, such as Chantix and Zyban.
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