Axsome Therapeutics

Axsome Therapeutics, Inc. is a biopharmaceutical company developing therapies for central nervous system (CNS) disorders. The company is public, based in New York, USA, founded in 2012. Nasdaq ticker is AXSM.

Clinical trials:

AXS-05 for alzheimer’s disease agitation, major depressive disorder, smoking cessation. AXS-05 is an oral N-methyl-D-aspartate (NMDA) receptor antagonist with multimodal activity for the treatment of major depressive disorder (MDD).
AXS-07 for migraine. AXS-07 is an oral multi-mechanistic medicine for the acute treatment of migraine. AXS-07 consists of MoSEIC (Molecular Solubility Enhanced Inclusion Complex) meloxicam and rizatriptan.
AXS-12 for narcolepsy: orphan drug designation. AXS-12, reboxetine, is an oral medicine in development for the treatment of narcolepsy.
AXS-14 for fibromyalgia. AXS-14, esreboxetine is an oral medicine in development for the treatment of fibromyalgia.

Axsome has garnered Breakthrough Therapy Status from the FDA for three indications.

Timeline

Patents

Further Resources

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Author

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Type

Date

ASENT 2021 ANNUAL MEETING - PIPELINE PRESENTATIONS: Dr Cedric O'Gorman

https://www.youtube.com/watch?v=53AoSTCG5ts

Web

February 24, 2021

ASENT 2021 ANNUAL MEETING - PIPELINE PRESENTATIONS: Dr. Amanda Jones

https://www.youtube.com/watch?v=ka0Tcgiifq0

Web

March 15, 2021

Our Science | Axsome Therapeutics

https://www.axsome.com/science

Web

Pipeline Acute Treatment for Migraine: AXS-07 - Spotlight on Migraine S3:Ep8

https://www.youtube.com/watch?v=vREHECyiNY8

Web

February 22, 2021

News

Title

Author

Date

Publisher

Description

FDA finds fault with Axsome's depression filing, sinking stock

Nick Paul

August 10, 2021

FierceBiotech

The FDA has identified deficiencies in Axsome Therapeutics' submission for approval of AXS-05 in major depressive disorder. With less than two weeks to go until the PDUFA action date, Axsome is yet to learn the nature of the deficiencies or their implications for its filing.

Axsome Therapeutics AXS-05 Priority Review by FDA Could Speed Up Help for MDD Patients

Ava Barnes

April 26, 2021

BioSpace

In keeping with Axsome's mission of providing a solution for central nervous system (CNS) disorders that are difficult to treat, AXS-05 was developed to help patients exhibiting treatment-resistant depression (TRD) and major depressive disorder (MDD).

Axsome Therapeutics AXS-05 Priority Review by FDA Could Speed Up Help for MDD Patients

Ava Barnes

April 26, 2021

BioSpace

Axsome Therapeutics and Veeva Systems Partner to Build Axsome's Digital-Centric CommercializationTM Platform

BioSpace

November 4, 2020

BioSpace

Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, and Veeva Systems (NYSE: VEEV), today announced a strategic partnership to augment the build of Axsome's Digital-Centric Commercialization (DCCTM) platform.

Axsome Therapeutics and Veeva Systems Partner to Build Axsome's Digital-Centric CommercializationTM Platform

BioSpace

November 4, 2020

BioSpace