AXSM · Company research
3 upcoming catalysts · 0 phase 2+ trials on file
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Axsome expects to report results from its Phase 3 study of Solriamfetol (Sunosi) for Binge eating disorder in Q4 2026 (Oct–Dec) (no exact date yet). Phase 3 is the last stage before a drug can be approved, so this result usually decides the program’s future.
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The FDA is due to decide by May 1, 2027 whether to approve Axsome’s AXS-12 (reboxetine) for Cataplexy in narcolepsy. Approval clears it for sale in the US; a rejection usually arrives as a letter listing what has to be fixed first.
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Axsome expects to report results from its Phase 3 study of Solriamfetol (Sunosi) for Shift work disorder during 2027 (no exact date yet). Phase 3 is the last stage before a drug can be approved, so this result usually decides the program’s future.
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Initiation of pivotal Phase 2/3 trial of AXS-05 in smoking cessation, in Q3 2026 (Jul–Sep). A company milestone for Axsome (AXS-05 (Auvelity, dextromethorphan-bupropion) for Smoking cessation): a step in the program rather than a decision or a data readout.
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FDA accepts AXS-12 NDA for cataplexy in narcolepsy; PDUFA May 1, 2027, on Jul 15, 2026. A company milestone for Axsome (AXS-12 (reboxetine) for Cataplexy in narcolepsy): a step in the program rather than a decision or a data readout.
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The FDA approved Axsome’s AUVELITY (AXS-05, dextromethorphan-bupropion) for Agitation associated with Alzheimer's dementia on Apr 30, 2026. The company can now sell it in that market.
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