Axsome Therapeutics (AXSM) — Stock, Pipeline & Market Cap

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AXSM · Stock Price

USD 220.22+111.36 (+102.30%)

Market Cap: $11.3B

Historical price data

Overview

Axsome Therapeutics is a commercial-stage biopharmaceutical company dedicated to developing and commercializing novel therapies for central nervous system (CNS) disorders. Founded in 2012, the company has transitioned from a development-focused entity to a revenue-generating commercial organization with three FDA-approved products: Auvelity (AXS-05) for MDD, Sunosi for narcolepsy/OSA, and Symbravo for migraine. Its core strategy leverages a differentiated platform focused on synergistic drug combinations and novel formulations to address significant unmet needs in psychiatry, neurology, and pain, driving a market valuation exceeding $8 billion.

PsychiatryNeurologyPain

Technology Platform

A development platform focused on creating novel CNS therapies through synergistic multi-mechanistic drug combinations and proprietary formulation strategies, optimizing pharmacokinetics and therapeutic profiles of known molecules.

Pipeline

36

36 drugs in pipeline23 in Phase 3

Drug	Indication	Stage
Solriamfetol + Placebo	Excessive Daytime Sleepiness	Approved
Solriamfetol 75 MG	Insomnia	Approved
AXS-05 + Bupropion	Major Depressive Disorder	Approved
Solriamfetol Oral Tablet + Placebo	Excessive Sleepiness	Approved
AXS-05 (dextromethorphan and bupropion) oral tablets	Major Depressive Disorder	Phase 3

FDA Approved Drugs

3

SYMBRAVONDAJan 30, 2025

AUVELITYNDAAug 18, 2022

SUNOSINDAMar 20, 2019

Opportunities

Axsome's primary near-term opportunity is the potential approval of AXS-05 for Alzheimer's disease agitation, a multi-billion dollar market with no FDA-approved therapies.

Additionally, expanding the label of Sunosi into Major Depressive Disorder with excessive daytime sleepiness and successfully launching Symbravo for migraine represent significant revenue growth drivers.

Risk Factors

Key risks include the high-stakes, binary outcome of the Phase 3 ACCORD trial for Alzheimer's agitation, intense commercial competition in the depression and migraine markets, and the company's ability to achieve profitability while funding late-stage clinical programs.

Safety concerns or patent challenges could also impact commercial assets.

Competitive Landscape

Axsome faces intense competition across its portfolio: Auvelity competes in a crowded MDD market against SSRIs, SNRIs, and novel agents like Spravato; Symbravo enters a competitive migraine market dominated by triptans and gepants. In Alzheimer's agitation, AXS-05 would compete against off-label antipsychotics, with safety and efficacy profile being critical differentiators.

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