FDA decisionMay 1, 2027in 186 days

PDUFA date for AXS-12 in cataplexy associated with narcolepsy

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.

Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary

DetailsFDA decision due · also called: PDUFA date

Company: Axsome Therapeutics, Inc. AXSM
Drug: AXS-12 (reboxetine)
For: Cataplexy in narcolepsy
Stage: NDA under FDA review
When: May 1, 2027
Source note: FDA accepted the AXS-12 NDA (announced July 15, 2026) and assigned a PDUFA target action date of May 1, 2027.
Checked: Checked by a person when it was added

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Source: globenewswire.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
Drugs@FDA ↗ — search the drug name for approval letters
AXSM headlines on this site

Axsome Therapeutics, Inc.

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Trial resultsAXSMAxsomeQ4 2026

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

Trial resultsAXSMAxsome2027

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.