Axsome Therapeutics, Inc.

AXSM

$3.20B

Mid Cap

NASDAQPharmaceutical Preparations🇺🇸North AmericaNEW YORK816 employees

Drugs in Pipeline

Phase 3 Programs

Upcoming Catalysts

Next Catalyst

Apr 3, 2026

Data is aggregated from public sources (FDA, SEC, ClinicalTrials.gov). While we strive for accuracy, information may be incomplete, delayed, or contain errors. Terms apply

Market Overview

Stock performance and market intelligence

Catalyst Timeline

3 upcoming, 1 past

🎯PDUFANext

FDA PDUFA Date AXS-05 (standard)

4/3/2026

For major depressive disorder. NDA filing. Extracted from SEC filing: 8-K

Source

⭐Phase 3

Solriamfetol 150 mg Phase 3 Results Expected

December 2026~Solriamfetol 150 mg520

Primary completion for Solriamfetol 150 mg trial (NCT06568367) in Excessive Sleepiness

Source

⭐Phase 3

Solriamfetol 300 mg Phase 3 Results Expected

December 2026~Solriamfetol 300 mg520

Primary completion for Solriamfetol 300 mg trial (NCT06568367) in Excessive Sleepiness

Source

AI Predictions & Institutional Flow

Machine learning insights and smart money movement

FDA Submissions

Pending NDA/BLA submissions with predicted PDUFA dates

Drug Pipeline

Clinical development programs and drug candidates

Drug Pipeline

AXS-05

Phase 3

Agitation in Patients With Dementia of the Alzheimer's Type

AXS-12 (reboxetine)

Phase 3

Narcolepsy

Solriamfetol 150 mg

Phase 3

Excessive Sleepiness

AXS-05 (dextromethorphan and bupropion) oral tablets

Phase 3

Major Depressive Disorder

Solriamfetol 300 mg

Phase 3

Binge-Eating Disorder

AXS-07

Phase 3

Migraine

AXS-07 (MoSEIC meloxicam and rizatriptan)

Phase 3

Migraine

AXS-07 (meloxicam-rizatriptan)

Phase 3

Migraine

Bupropion

Phase 3

Major Depressive Disorder

AXS-05 (dextromethorphan-bupropion)

Phase 3

Treatment Resistant Depression

Drug Name	Phase	Indication	Designations
AXS-05	Phase 3	Agitation in Patients With Dementia of the Alzheimer's Type	-
AXS-12 (reboxetine)	Phase 3	Narcolepsy	-
Solriamfetol 150 mg	Phase 3	Excessive Sleepiness	-
AXS-05 (dextromethorphan and bupropion) oral tablets	Phase 3	Major Depressive Disorder	-
Solriamfetol 300 mg	Phase 3	Binge-Eating Disorder	-
AXS-07	Phase 3	Migraine	-
AXS-07 (MoSEIC meloxicam and rizatriptan)	Phase 3	Migraine	-
AXS-07 (meloxicam-rizatriptan)	Phase 3	Migraine	-
Bupropion	Phase 3	Major Depressive Disorder	-
AXS-05 (dextromethorphan-bupropion)	Phase 3	Treatment Resistant Depression	-

Regulatory & News

Approvals, filings, and latest developments

Regulatory Approvals

AXSM News