FDA approves AUVELITY for agitation associated with Alzheimer's dementia
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.
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary
- Company
- Axsome Therapeutics, Inc. AXSM
- Drug
- AUVELITY (AXS-05, dextromethorphan-bupropion)
- For
- Agitation associated with Alzheimer's dementia
- Stage
- Regulatory (sNDA/PDUFA)
- When
- Apr 30, 2026
- Source note
- FDA approved AUVELITY (dextromethorphan HBr/bupropion HCl) for agitation associated with dementia due to Alzheimer's disease, making it the first non-antipsychotic cleared for the indication. The drug was reviewed under Priority Review with Breakthrough Therapy designation.
- Checked
- Checked by a person when it was added
- Source: alz.org ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- Drugs@FDA ↗ — search the drug name for approval letters
- AXSM headlines on this site
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.
More details
- Entry
- ENGAGE Phase 3 topline: solriamfetol in binge eating disorder · Clinical trial results (readout / topline data)
- Drug
- Solriamfetol (Sunosi)
- For
- Binge eating disorder
- Stage
- Phase 3 · the last stage before a drug can be approved
- When
- Q4 2026 · the company gave a window, not a day
- Source note
- Q2 2026 press release (Aug 10, 2026): 'The Company anticipates topline results from the ENGAGE Phase 3 trial in the fourth quarter of 2026.'
- Checked
- Checked by a person when it was added
- Verify it
- Source: biospace.com ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- AXSM headlines on this site
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page
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.
More details
- Entry
- SUSTAIN Phase 3 topline: solriamfetol in shift work disorder · Clinical trial results (readout / topline data)
- Drug
- Solriamfetol (Sunosi)
- For
- Shift work disorder
- Stage
- Phase 3 · the last stage before a drug can be approved
- When
- 2027 · the company gave a window, not a day
- Source note
- Company guides topline results from the SUSTAIN Phase 3 trial 'in 2027' (year-level precision only).
- Checked
- Checked by a person when it was added
- Verify it
- Source: biospace.com ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- AXSM headlines on this site
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page