Achieve Life Sciences Grants Stock Options, Files NDA for Nicotine Dependence Treatment
Achieve Life Sciences, Inc. has granted stock options to five new employees and submitted a news Drug Application (NDA) for cytisinicline to treat nicotine dependence for smoking cessation in adults. The stock options, made as an inducement, have a ten-year term and a specific vesting schedule.
The stock options have an exercise price equal to Achieve's common stock closing price on October 1, 2025. They vest in two stages: 25% on the first anniversary, followed by 75% in 36 equal monthly installments. This plan aligns with Nasdaq Listing Rule 5635(c)(4).
Achieve's recent developments include conducting a Phase 2 study and holding an end-of-Phase 2 meeting with the FDA for cytisinicline in vaping cessation. The company submitted an NDA for cytisinicline in June 2025, accepted for review with a PDUFA date of June 20, 2026. This NDA is based on two successfully completed Phase 3 studies and an open-label safety study. Cytisinicline, a plant-derived alkaloid, has shown high binding affinity to the nicotinic acetylcholine receptor, aiding in treating nicotine dependence for smoking and e-cigarette cessation. It has also been granted Breakthrough Therapy designation by the FDA for addressing nicotine e-cigarette cessation.
With approximately 29 million adult smokers in the United States and tobacco use being the leading cause of preventable death worldwide, Achieve's work on cytisinicline holds significant potential. The company's stock option plan for new employees reflects its commitment to attracting and retaining top talent in its mission to address nicotine dependence.