Axsome Therapeutics’ AXSM Auvelity (AXS-05) was launched in the US in 2022 for the remedy of main depressive dysfunction (MDD), making it the primary authorized drug within the firm’s portfolio.
Auvelity generated gross sales value $291.4 million in 2024, reflecting a rise of 124% yr over yr in the US. Gross sales of the drug are being pushed by a rise in unit gross sales quantity and the momentum is prone to proceed in 2025.
Axsome can also be working to increase the label of Auvelity for the bigger business alternative in different central nervous system (CNS) issues like Alzheimer’s illness (AD) agitation and smoking cessation.
Auvelity & Sunosi Help AXSM
Axsome plans to submit a brand new drug utility (NDA) for AXS-05 in AD agitation to the FDA within the second half of 2025. The corporate additionally plans to provoke a section II/III pivotal examine on AXS-05 for smoking cessation later in 2025.
The profitable growth and potential approval of Auvelity in further indications will assist the drug handle a broader affected person inhabitants and drive gross sales additional.
Axsome acquired U.S. rights to Sunosi, a commercialized drug focusing on narcolepsy, from Jazz Prescription drugs JAZZ in 2022. It started promoting Sunosi within the U.S. market in Might 2022 and in sure worldwide markets in November 2022.
Jazz had obtained approval for Sunosi as a remedy for narcolepsy in 2019.
JAZZ is entitled to obtain a excessive single-digit royalty from Axsome on web gross sales of Sunosi in the US. AXSM out-licensed its ex-U.S. advertising and marketing rights of Sunosi to Pharmanovia in February 2023.
Sunosi has grow to be an vital income driver for Axsome since its acquisition from Jazz. The drug generated gross sales value $94.3 million in 2024, reflecting a rise of 26% on a year-over-year foundation.
Axsome is evaluating Sunosi in separate section III research for treating consideration deficit hyperactivity dysfunction (ADHD), MDD, binge consuming dysfunction and extreme sleepiness related to shift work dysfunction.
High-line knowledge from the FOCUS examine and the PARADIGM examine, evaluating Sunosi for treating ADHD and MDD, respectively, are anticipated to be launched later within the first quarter of 2025.
New Medication Approvals an Added Increase for AXSM
In January 2025, the FDA authorized Axsome’s Symbravo (meloxicam and rizatriptan) or AXS-07 for the acute remedy of migraine with or with out aura in adults. The corporate expects to launch Symbravo in the US in about 4 months. The approval has diversified Axsome’s business portfolio and may enhance the corporate’s development prospects.
This aside, Axsome is nearing two potential approvals for its different pipeline candidates. The corporate plans to submit an NDA to the FDA searching for approval of AXS-14 for the remedy of fibromyalgia later within the first quarter of 2025.
Axsome additionally plans to submit an NDA for AXS-12 for treating cataplexy in sufferers with narcolepsy to the FDA within the second half of 2025.
The regular efficiency of Auvelity and Sunosi, together with the current drug approval and inspiring pipeline progress, ought to preserve momentum for Axsome.
Stiff Competitors for AXSM’s Merchandise
Although Axsome is driving on the success of Auvelity and Sunosi, competitors looms giant within the goal market as many firms are creating therapies to handle varied CNS issues. One such firm is Acadia Prescription drugs ACAD, which at present markets its lead drug, Nuplazid (pimavanserin).
ACAD’s Nuplazid is the primary and solely drug authorized by the FDA for the remedy of hallucinations and delusions related to Parkinson’s illness psychosis.
Acadia can also be creating different pipeline candidates focusing on varied different CNS issues. Sunosi can also be prone to face competitors from Jazz’s sleep problem medication, which maintain a robust market share.
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Jazz Pharmaceuticals PLC (JAZZ) : Free Stock Analysis Report
ACADIA Pharmaceuticals Inc. (ACAD) : Free Stock Analysis Report
Axsome Therapeutics, Inc. (AXSM) : Free Stock Analysis Report
This article originally published on Zacks Investment Research (zacks.com).
The views and opinions expressed herein are the views and opinions of the writer and don’t essentially mirror these of Nasdaq, Inc.
