Aug. 14 at 7:09 PM
$AXSM Axsome is running this Phase 3 trial as a treatment study aimed directly at smoking cessation outcomes. The parallel design means each group is treated at the same time, which makes it easier to compare quit rates and safety between AXS-05, the active control bupropion, and placebo under similar conditions.
The study was first submitted on August 11, 2026, which marks the formal launch of the program in public registries. The same date is listed as the last update so far, signaling that the protocol has just been posted and that recruiting is underway, with future key dates like primary and final completion still to be set.
For investors, a successful Phase 3 smoking cessation result could add a new use for AXS-05 and support Axsome’s stock over time. It would place the company in a large market now led by older drugs like bupropion and varenicline, and could lift sentiment if early signals show better quit rates or a cleaner safety profile.
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