Axsome Therapeutics Inc.

AXSM

Held by 12 specialist biotech funds

High Convergence

12 funds opened new positions. Next phase3 readout (Solriamfetol 150 mg): Dec 2025. Short interest: 9.8% of float.

BiotechnologyCEO: Herriot TabuteauIPO: 2015Website ↗

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.

Catalysts

Phase 3PositiveQ4 2019AXS-05Depression, Major Depressive DisorderNCT04019704

Primary: Change in MADRS Total Score From Baseline to Week 6 (6 weeks)Enrollment:327/327Sites: 43RANDOMIZED, QUADRUPLE, TREATMENT

Phase 3Q4 2019AXS-07 (MoSEIC meloxicam and rizatriptan)MigraineNCT03896009

Primary: Percentage of Subjects Reporting Headache Pain Freedom (Hour 2 following dose administration)Enrollment:1,594/1,594Sites: 85RANDOMIZED, DOUBLE, TREATMENT

Phase 3Q1 2020AXS-07 (MoSEIC meloxicam and rizatriptan)MigraineNCT04163185

Primary: Percentage of Subjects Achieving Headache Pain Freedom at Hour 2 (Hour 2)Enrollment:302/302Sites: 41RANDOMIZED, DOUBLE, TREATMENT

Phase 3PositiveQ2 2020AXS-05Agitation in Patients With Dementia of the Alzheimer's Type, Alzheimer Disease, Agitation, PsychomotorNCT03226522

Phase 3Q3 2020AXS-07MigraineNCT04068051

Phase 3Q4 2020AXS-05 (dextromethorphan and bupropion) oral tabletsMajor Depressive Disorder, Treatment Resistant Depression, DepressionNCT04039022

Primary: Incidence of Treatment-emergent AEs (TEAEs) Following Dosing With AXS-05 (Up to 12 months)Enrollment:876/876Sites: 51NA, TREATMENT

Phase 2PositiveQ3 2021AXS-05Treatment Resistant Depression, Major Depressive DisorderNCT04608396

Primary: Relapse (Time from randomization to first relapse (up to 52 weeks))Enrollment:44/44Sites: 20RANDOMIZED, DOUBLE, TREATMENT

Phase 2NegativeQ1 2022AXS-05 (dextromethorphan-bupropion)Treatment Resistant Depression, Major Depressive DisorderNCT04634669

Primary: Incidence of Treatment-emergent AEs (TEAEs) Following Dosing With AXS-05 (Duration of participation was up to 15 months. TEAEs were defined as any AE with an onset date in the interval between the first study treatment dosing date and 7 days after the last study treatment dosing date.)Enrollment:181/181Sites: 20NA, TREATMENT

Phase 3Q4 2022AXS-05Agitation in Patients With Dementia of the Alzheimer's Type, Alzheimer Disease, Agitation, PsychomotorNCT04797715

Phase 3Q1 2024AXS-12 (reboxetine)Narcolepsy, Cataplexy, Excessive Daytime SleepinessNCT05059223

Phase 3Q4 2024AXS-12 (reboxetine)Narcolepsy, Cataplexy, Excessive Daytime SleepinessNCT05113745

Phase 3Q4 2024AXS-05Agitation in Patients With Dementia of the Alzheimer's Type, Alzheimer Disease, AgitationNCT05557409

Phase 3Q4 2024AXS-07 (meloxicam-rizatriptan)MigraineNCT05550207

Phase 3Q4 2024AXS-05 (dextromethorphan-bupropion)Agitation in Patients With Dementia of the Alzheimer's Type, Alzheimer Disease, Agitation, PsychomotorNCT04947553

Phase 3Q4 2024Solriamfetol 300 mgMajor Depressive DisorderNCT06360419

Phase 3Q1 2025Solriamfetol 150 mgADHDNCT05972044

Phase 3NegativeQ1 2025AXS-05 (dextromethorphan-bupropion)Agitation in Patients With Dementia of the Alzheimer's Type, Alzheimer Disease, Agitation, PsychomotorNCT06736509

Phase 3Q4 2025Solriamfetol 150 mgBinge-Eating DisorderNCT06413433

Primary: Change from Baseline to Week 12 in number of binge eating episodes (12 weeks)Enrollment:Target 450Sites: 45RANDOMIZED, DOUBLE, TREATMENT

Phase 2Dec 1, 2026SolriamfetolMultiple Sclerosis, Multiple Sclerosis FatigueNCT06170970

Primary: Modified Fatigue Impact Scale (MFIS) Score (Up to 4 weeks)Enrollment:Target 46Sites: 1RANDOMIZED, TRIPLE, TREATMENT

Phase 3Q4 2026Solriamfetol 150 mgExcessive Sleepiness, Shift-work DisorderNCT06568367

Primary: Change from Baseline to Week 12 in the mean sleep latency time as measured by the Maintenance of Wakefulness Test (MWT). (12 weeks)Enrollment:Target 520Sites: 49RANDOMIZED, DOUBLE, TREATMENT

Phase 3Q4 2027SolriamfetolADHDNCT07773883

Phase 3Q4 2027AXS-05 (dextromethorphan-bupropion)Smoking CessationNCT07766655

Phase 3Q4 2027SolriamfetolBinge-Eating DisorderNCT06878976

Phase 3Q1 2028AXS-14 (Esreboxetine)FibromyalgiaNCT07398417

Phase 3Q2 2028AXS-14 (esreboxetine)FibromyalgiaNCT07637162

Phase 3Q2 2028Solriamfetol Dose AADHDNCT07717879

Phase 3Q2 2028Solriamfetol Dose AADHDNCT07717892

Phase 3Q4 2028Solriamfetol 150 MGMajor Depressive Disorder With Excessive Daytime Sleepiness SymptomsNCT07484217

Primary: Time from randomization to relapse of depressive symptoms (Up to 24 weeks.)Enrollment:Target 508Sites: 40RANDOMIZED, DOUBLE, TREATMENT

Axsome Therapeutics Inc.

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