Company intelligence / Profile preview

AXS Group

New York, New York, United Statesaxs.com ↗

Overview

Axsome has three FDA-approved products:

Auvelity, the first rapid-onset oral treatment for major depressive disorder.
Sunosi, approved for excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea.
Symbravo/AXS–07, approved/acutely treating migraine. Late-stage assets include:
AXS–05, completed phase III trials in Alzheimer’s disease agitation and smoking cessation.
AXS–12, completed phase III trial in narcolepsy; NDA filing planned H2 2025.
AXS–14/esreboxetine, completed phase III trial in fibromyalgia but faced an FDA refusal-to-file letter due to study design issues—new pivotal study planned. The company continues to expand its indications through ongoing late-stage trials.

Research collaboration with Duke University on smoking cessation researchUses contract manufacturing organizations (CMOs) globally

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