Axsome Therapeutics Inc.

AXSM

Held by 11 specialist biotech funds

High Convergence

11 funds opened new positions. Next phase3 readout (AXS-05): Nov 2019. Short interest: 8.4% of float.

BiotechnologyCEO: Herriot TabuteauIPO: 2015Website ↗

Axsome Therapeutics, Inc., a biopharmaceutical company, engages in the development of novel therapies for central nervous system (CNS) disorders in the United States. The company's product pipeline includes AXS-05, a therapeutic for the treatment of major depressive disorder and resistant depression disorders; and that is in the Phase III clinical trial to treat Alzheimer's disease agitation, as well as that has completed phase II clinical trial for the treatment of smoking cessation. It is also developing AXS-07, a novel, oral, rapidly absorbed, multi-mechanistic, and investigational medicine that has completed two Phase III trials for the acute treatment of migraine; AXS-12, a selective and potent norepinephrine reuptake inhibitor, which is in Phase III trial to treat narcolepsy; and AXS-14, a novel, oral, and investigational medicine that is in Phase III trial for the treatment of fibromyalgia. Axsome Therapeutics, Inc. has a research collaboration agreement with Duke University for evaluating AXS-05 in smoking cessation. The company was incorporated in 2012 and is based 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 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 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 3Q4 2022AXS-05Agitation in Patients With Dementia of the Alzheimer's Type, Alzheimer Disease, Agitation, PsychomotorNCT04797715

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 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

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

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

Phase 3Q4 2026Solriamfetol 75mg, 150 mg, or 300 mgBinge-Eating DisorderNCT06878976

Phase 3Q1 2028AXS-14 (Esreboxetine)FibromyalgiaNCT07398417

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: 13RANDOMIZED, DOUBLE, TREATMENT

Axsome Therapeutics Inc.

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