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Axsome Therapeutics, Inc. (AXSM)

Axsome Therapeutics, Inc. is a biopharmaceutical company dedicated to discovering and advancing innovative treatments for a range of central nervous system (CNS) disorders within the United States. Its robust product pipeline features several promising candidates, including: AXS-05, an investigational therapy currently being developed for major depressive disorder and treatment-resistant depression. This compound is also in Phase III clinical evaluation for Alzheimer's disease agitation and has successfully finished Phase II trials investigating its use for smoking cessation. AXS-07, a novel, orally administered, rapidly-acting investigational medicine that employs multiple mechanisms of action. It has concluded two Phase III studies for the acute treatment of migraine attacks. AXS-12, a selective and potent norepinephrine reuptake inhibitor, which is presently undergoing a Phase III trial for narcolepsy. AXS-14, an oral investigational drug, advancing through Phase III trials for the management of fibromyalgia. Axsome Therapeutics also engages in a research collaboration with Duke University to further assess AXS-05's potential in smoking cessation. The company, established in 2012, has its main offices in New York, New York.

Sector: Pharmaceutical Preparations

Industry: Biotechnology

Axsome Therapeutics, Inc. logo

Axsome Therapeutics, Inc.

NASDAQ:AXSMHealthcare
+0.68%$144.43
AH$146.85+1.68%vs close
Mkt Cap$7.57B
Float40.93M
O/S52.38M
Vol
$ Vol
RVOL
Inst Own72.7%
SI7.6%
Earnings
Dilution
Axsome Therapeutics, Inc. logoNASDAQ:AXSM$144.43+0.68%
Upcoming Catalysts
  • AXS-12PDUFA
    cataplexy in narcolepsy
    Cash runway at this date: 2yr
    May 1, 2027in 180 days8-K
  • AXS-12 (reboxetine)PDUFA
    cataplexy in narcolepsy
    Cash runway at this date: 2yr
    May 1, 2027in 180 days8-K
Phase Distribution
37 lead-sponsored trials·12 active·20 completed
Phase 11
Phase 25
Phase 2/31
Phase 327
Phase 42
Not applicable1
(5 more as collaborator)

Trials need funding. See this company's dilution risk and cash position.

Clinical Trials
Sponsor role
Status
Phase
  • Phase 4
    Completed

    Solriamfetol's Effect on Cognitive Health in Apnea Participants During a Randomized Placebo-controlled Study

    Solriamfetol, Placebo

    Excessive Daytime Sleepiness, Obstructive Sleep Apnea +1

    Enrollment
    59
    Start
    May 2021
    Primary Completion
    Sep 2022
    Completion
    Sep 2022
    NCT04789174
  • Phase 4
    Recruiting

    A Study to Evaluate the Efficacy of AXS-05 Compared to Bupropion in Preventing the Relapse of Depressive Symptoms

    AXS-05, Bupropion

    Major Depressive Disorder

    Enrollment
    350
    Start
    Dec 2023
    Primary Completion
    Mar 2026est.
    Completion
    Mar 2026est.
    NCT06223880
  • Phase 3
    Unknown status

    CREATE-1: A Study to Assess the Efficacy and Safety of AXS-02 in Patients With CRPS-1

    AXS-02 (oral zoledronate), Placebo

    Complex Regional Pain Syndrome, Reflex Sympathetic Dystrophy

    Enrollment
    190
    Start
    Jul 2015
    Primary Completion
    Jan 2019est.
    Completion
    Jan 2019est.
    NCT02504008
  • Phase 3
    Completed

    A Study to Assess the Efficacy and Safety of AXS-05 in Subjects With Treatment Resistant Major Depressive Disorder

    AXS-05, Bupropion

    Treatment Resistant Major Depressive Disorder

    Enrollment
    312
    Start
    Mar 2016
    Primary Completion
    Mar 2020
    Completion
    Mar 2020
    NCT02741791
  • Phase 3
    Unknown status

    A Study to Assess the Efficacy and Safety of AXS-02 in Subjects With Knee OA Associated With Bone Marrow Lesions

    AXS-02, Placebo

    Osteoarthritis, Knee

    Enrollment
    346
    Start
    Mar 2016
    Primary Completion
    Dec 2020est.
    Completion
    Dec 2020est.
    NCT02746068
  • Phase 3
    Completed

    Maximizing Outcomes in Treating Acute Migraine

    AXS-07 (MoSEIC meloxicam and rizatriptan), Meloxicam

    Migraine

    Enrollment
    1,594
    Start
    Mar 2019
    Primary Completion
    Dec 2019
    Completion
    Dec 2019
    NCT03896009
  • Phase 3
    Completed

    A Trial of AXS-05 in Patients With Major Depressive Disorder

    AXS-05, Placebo

    Depression, Major Depressive Disorder

    Enrollment
    327
    Start
    Jun 2019
    Primary Completion
    Nov 2019
    Completion
    Dec 2019
    NCT04019704
  • Phase 3
    Completed

    Open-Label Safety Study of AXS-05 in Subjects With Depression

    AXS-05 (dextromethorphan and bupropion) oral tablets

    Major Depressive Disorder, Treatment Resistant Depression +1

    Enrollment
    876
    Start
    Jul 2019
    Primary Completion
    Oct 2020
    Completion
    Oct 2020
    NCT04039022
  • Phase 3
    Completed

    Multimechanistic Treatment Over Time of Migraine Symptoms (MOVEMENT)

    AXS-07

    Migraine

    Enrollment
    706
    Start
    Jul 2019
    Primary Completion
    Sep 2020
    Completion
    Sep 2020
    NCT04068051
  • Phase 3
    Completed

    Initiating Early Control of Migraine Pain and Associated Symptoms

    AXS-07 (MoSEIC meloxicam and rizatriptan), Placebo

    Migraine

    Enrollment
    302
    Start
    Oct 2019
    Primary Completion
    Mar 2020
    Completion
    Mar 2020
    NCT04163185
  • Phase 3
    Completed

    Assessing Clinical Outcomes in Alzheimer's Disease Agitation

    AXS-05, Placebo

    Agitation in Patients With Dementia of the Alzheimer's Type, Alzheimer Disease +1

    Enrollment
    178
    Start
    Dec 2020
    Primary Completion
    Nov 2022
    Completion
    Nov 2022
    NCT04797715
  • Phase 3
    Completed

    A Study to Assess the Long-term Safety and Efficacy of AXS-05 in Subjects With Alzheimer's Disease Agitation

    AXS-05 (dextromethorphan-bupropion), Placebo

    Agitation in Patients With Dementia of the Alzheimer's Type, Alzheimer Disease +1

    Enrollment
    456
    Start
    Jun 2021
    Primary Completion
    Dec 2024
    Completion
    Dec 2024
    NCT04947553
  • Phase 3
    Completed

    A Study to Assess the Efficacy and Safety of AXS-12 (Reboxetine) in Patients With Narcolepsy

    AXS-12 (reboxetine), Placebo

    Narcolepsy, Cataplexy +1

    Enrollment
    90
    Start
    Sep 2021
    Primary Completion
    Mar 2024
    Completion
    Mar 2024
    NCT05059223
  • Phase 3
    Completed

    A Study to Assess the Long-term Efficacy and Safety of AXS-12 (Reboxetine) in Subjects With Narcolepsy (ENCORE)

    AXS-12 (reboxetine), Placebo

    Narcolepsy, Cataplexy +1

    Enrollment
    68
    Start
    Oct 2021
    Primary Completion
    Nov 2024
    Completion
    Nov 2024
    NCT05113745
  • Phase 3
    Completed

    Open-Label Study of AXS-07 for the Acute Treatment of Migraine in Adults With a Prior Inadequate Response to an Oral CGRP Inhibitor (EMERGE)

    AXS-07 (meloxicam-rizatriptan)

    Migraine

    Enrollment
    100
    Start
    Aug 2022
    Primary Completion
    Nov 2024
    Completion
    Nov 2024
    NCT05550207
  • Phase 3
    Completed

    A Study to Assess the Efficacy and Safety of AXS-05 in Subjects With Alzheimer's Disease Agitation

    AXS-05, Placebo

    Agitation in Patients With Dementia of the Alzheimer's Type, Alzheimer Disease +1

    Enrollment
    408
    Start
    Sep 2022
    Primary Completion
    Nov 2024
    Completion
    Dec 2024
    NCT05557409
  • Phase 3
    Completed

    A Study to Assess the Efficacy and Safety of Solriamfetol in Subjects With ADHD (FOCUS)

    Solriamfetol 150 mg, Solriamfetol 300 mg

    ADHD

    Enrollment
    516
    Start
    Jul 2023
    Primary Completion
    Feb 2025
    Completion
    Mar 2025
    NCT05972044
  • Phase 3
    Completed

    Progressing TAAR-1, Dopamine, and Norepinephrine in Depression Using Solriamfetol

    Solriamfetol 300 mg, Placebo

    Major Depressive Disorder

    Enrollment
    346
    Start
    Mar 2024
    Primary Completion
    Dec 2024
    Completion
    Mar 2025
    NCT06360419
  • Phase 3
    Recruiting

    Elucidating TAAR-1, Dopamine, and Norepinephrine in Binge Eating Disorder Using Solriamfetol

    Solriamfetol 150 mg, Solriamfetol 300 mg

    Binge-Eating Disorder

    Enrollment
    450
    Start
    Apr 2024
    Primary Completion
    Dec 2026est.
    Completion
    Dec 2026est.
    NCT06413433
  • Phase 3
    Recruiting

    Studying Solriamfetol Modulation of TAAR-1, Dopamine, and Norepinephrine in Shift Work Disorder (SUSTAIN)

    Solriamfetol 150 mg, Solriamfetol 300 mg

    Excessive Sleepiness, Shift-work Disorder

    Enrollment
    520
    Start
    Aug 2024
    Primary Completion
    Dec 2026est.
    Completion
    Dec 2026est.
    NCT06568367
  • Phase 3
    Terminated

    An Open-Label Study to Assess the Long-term Safety of AXS-05 in Subjects With Dementia of the Alzheimer's Type, ADVANCE-2 and ACCORD-2 Extension Study

    AXS-05 (dextromethorphan-bupropion)

    Agitation in Patients With Dementia of the Alzheimer's Type, Alzheimer Disease +1

    Enrollment
    139
    Start
    Nov 2024
    Primary Completion
    Feb 2025
    Completion
    Apr 2025
    NCT06736509
  • Phase 3
    Enrolling by invitation

    A Study to Assess the Long-term Safety and Efficacy of Solriamfetol in Subjects With Binge Eating Disorder

    Solriamfetol, Placebo

    Binge-Eating Disorder

    Enrollment
    236
    Start
    Feb 2025
    Primary Completion
    Dec 2027est.
    Completion
    Dec 2027est.
    NCT06878976
  • Phase 3
    Recruiting

    Fibromyalgia Response With Esreboxetine Evaluated Using a Randomized Withdrawal Research Design

    AXS-14 (Esreboxetine), Placebo

    Fibromyalgia

    Enrollment
    620
    Start
    Jan 2026
    Primary Completion
    Mar 2028est.
    Completion
    Mar 2028est.
    NCT07398417
  • Phase 3
    Recruiting

    Clinical Assessment of Response in the Treatment of Depression With Daytime Sleepiness Using Solriamfetol

    Solriamfetol 150 MG, Placebo

    Major Depressive Disorder With Excessive Daytime Sleepiness Symptoms

    Enrollment
    508
    Start
    Feb 2026
    Primary Completion
    Dec 2028est.
    Completion
    Dec 2028est.
    NCT07484217
  • Phase 3
    Enrolling by invitation

    Open-Label Safety Study of AXS-14 in Subjects With Fibromyalgia

    AXS-14 (esreboxetine)

    Fibromyalgia

    Enrollment
    300
    Start
    Apr 2026
    Primary Completion
    May 2028est.
    Completion
    May 2028est.
    NCT07637162

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