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Will Auvelity & Sunosi Fuel Axsome's Growth Amid Stiff Competition?
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Axsome Therapeutics’ (AXSM - Free Report) Auvelity (AXS-05) was launched in the United States in 2022 for the treatment of major depressive disorder (MDD), making it the first approved drug in the company’s portfolio.
Auvelity generated sales worth $118.4 million in the first half of 2024, up 172.8% year over year, owing to strong underlying demand.
AXSM is also conducting several label expansion studies on Auvelity targeting other central nervous system (CNS) disorders like Alzheimer’s disease (AD) associated agitation and smoking cessation.
Auvelity & Sunosi Aid AXSM
Currently, two separate phase III studies are evaluating Auvelity for treating agitation associated with AD. Top-line data from both studies are expected later in the second half of 2024. The company is planning to initiate a phase II/III pivotal study on AXS-05 for smoking cessation later in 2024.
The successful development and subsequent commercialization of Auvelity in additional indications will help the drug address a broader patient population and drive sales further.
Axsome acquired U.S. rights to Sunosi, a commercialized drug targeting narcolepsy, from Jazz Pharmaceuticals (JAZZ - Free Report) in May 2022. It began selling Sunosi in the U.S. market in May 2022 and in certain international markets in November 2022.
Jazz received approval for Sunosi as a treatment for narcolepsy in 2019.
In the first half of 2024, Sunosi’s net product sales were $42.2 million, reflecting an increase of almost 35.2% year over year. Sunosi has become an important revenue driver for Axsome.
The acquisition of Sunosi from Jazz diversified Axsome’s portfolio, helping it reach a larger patient population and driving the company’s growth prospects.
The steady performance of Auvelity and Sunosi, along with encouraging pipeline progress, has maintained momentum for AXSM.
AXSM's Promising Pipeline
Axsome has an impressive portfolio of pipeline candidates, including AXS-07, AXS-12 and AXS-14. All of these are being developed for various CNS indications.
AXS-07 is being developed for the acute treatment of migraine. Last month, the FDA accepted AXSM’s resubmitted new drug application (NDA), seeking approval for AXS-07 for the acute treatment of migraine.
A final decision from the regulatory body is expected on Jan. 31, 2025.
The FDA issued a complete response letter to the first NDA for AXS-07 in April 2022 as it identified issues related to chemistry, manufacturing and controls.
AXS-14 (esreboxetine) is being developed for the treatment of fibromyalgia. AXS-12 (reboxetine) is being evaluated in the phase III SYMPHONY study for the treatment of narcolepsy.
Stiff Competition for AXSM's Products
Though Axsome is riding on the success of Auvelity and Sunosi, competition looms large in the target market as many companies are developing treatments to address various CNS disorders. One such company is Acadia Pharmaceuticals (ACAD - Free Report) , which is currently developing Nuplazid (pimavanserin) in several studies targeting different CNS indications.
ACAD’s Nuplazid is already approved for hallucinations and delusions associated with Parkinson’s disease psychosis.
Acadia is studying pimavanserin for the treatment of other CNS disorders. Sunosi is also likely to face competition from Jazz’s other sleep disorder drugs, which hold a strong market share.
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Will Auvelity & Sunosi Fuel Axsome's Growth Amid Stiff Competition?
Axsome Therapeutics’ (AXSM - Free Report) Auvelity (AXS-05) was launched in the United States in 2022 for the treatment of major depressive disorder (MDD), making it the first approved drug in the company’s portfolio.
Auvelity generated sales worth $118.4 million in the first half of 2024, up 172.8% year over year, owing to strong underlying demand.
AXSM is also conducting several label expansion studies on Auvelity targeting other central nervous system (CNS) disorders like Alzheimer’s disease (AD) associated agitation and smoking cessation.
Auvelity & Sunosi Aid AXSM
Currently, two separate phase III studies are evaluating Auvelity for treating agitation associated with AD. Top-line data from both studies are expected later in the second half of 2024. The company is planning to initiate a phase II/III pivotal study on AXS-05 for smoking cessation later in 2024.
The successful development and subsequent commercialization of Auvelity in additional indications will help the drug address a broader patient population and drive sales further.
Axsome acquired U.S. rights to Sunosi, a commercialized drug targeting narcolepsy, from Jazz Pharmaceuticals (JAZZ - Free Report) in May 2022. It began selling Sunosi in the U.S. market in May 2022 and in certain international markets in November 2022.
Jazz received approval for Sunosi as a treatment for narcolepsy in 2019.
In the first half of 2024, Sunosi’s net product sales were $42.2 million, reflecting an increase of almost 35.2% year over year. Sunosi has become an important revenue driver for Axsome.
The acquisition of Sunosi from Jazz diversified Axsome’s portfolio, helping it reach a larger patient population and driving the company’s growth prospects.
The steady performance of Auvelity and Sunosi, along with encouraging pipeline progress, has maintained momentum for AXSM.
AXSM's Promising Pipeline
Axsome has an impressive portfolio of pipeline candidates, including AXS-07, AXS-12 and AXS-14. All of these are being developed for various CNS indications.
AXS-07 is being developed for the acute treatment of migraine. Last month, the FDA accepted AXSM’s resubmitted new drug application (NDA), seeking approval for AXS-07 for the acute treatment of migraine.
A final decision from the regulatory body is expected on Jan. 31, 2025.
The FDA issued a complete response letter to the first NDA for AXS-07 in April 2022 as it identified issues related to chemistry, manufacturing and controls.
AXS-14 (esreboxetine) is being developed for the treatment of fibromyalgia. AXS-12 (reboxetine) is being evaluated in the phase III SYMPHONY study for the treatment of narcolepsy.
Stiff Competition for AXSM's Products
Though Axsome is riding on the success of Auvelity and Sunosi, competition looms large in the target market as many companies are developing treatments to address various CNS disorders. One such company is Acadia Pharmaceuticals (ACAD - Free Report) , which is currently developing Nuplazid (pimavanserin) in several studies targeting different CNS indications.
ACAD’s Nuplazid is already approved for hallucinations and delusions associated with Parkinson’s disease psychosis.
Acadia is studying pimavanserin for the treatment of other CNS disorders. Sunosi is also likely to face competition from Jazz’s other sleep disorder drugs, which hold a strong market share.