FDA accepts AXS-12 NDA for cataplexy in narcolepsy; PDUFA May 1, 2027
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.
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary
- Company
- Axsome Therapeutics, Inc. AXSM
- Drug
- AXS-12 (reboxetine)
- For
- Cataplexy in narcolepsy
- Stage
- Regulatory (NDA filing acceptance)
- When
- Jul 15, 2026
- Source note
- FDA accepted for filing Axsome's NDA for AXS-12 (reboxetine) for cataplexy in narcolepsy and set a PDUFA target action date of May 1, 2027. The agency indicated it does not currently plan to hold an advisory committee meeting.
- Checked
- Checked by a person when it was added
- Source: stocktitan.net ↗ — 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