Initiation of pivotal Phase 2/3 trial of AXS-05 in smoking cessation
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.
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary
- Company
- Axsome Therapeutics, Inc. AXSM
- Drug
- AXS-05 (Auvelity, dextromethorphan-bupropion)
- For
- Smoking cessation
- Stage
- Phase 2/3 · a combined mid- to late-stage study
- When
- Q3 2026 · the company gave a window, not a day; the calendar never invents one
- Source note
- Q2 2026 press release: 'on track to initiate a pivotal Phase 2/3 trial of AXS-05 in smoking cessation in the third quarter of 2026.' Note: the AXS-05 Alzheimer's agitation PDUFA (April 30, 2026) already resolved in an FDA approval and is excluded as past.
- Checked
- Checked by a person when it was added
- 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
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