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Can Auvelity Drive Axsome's Growth Through the Rest of 2025?
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Key Takeaways
Axsome's Auvelity posted $215.9M in H1 2025 sales, which increased 82.3% year over year.
AXSM plans to file an sNDA for Auvelity in the AD agitation later in the third quarter of 2025.
Sunosi sales rose 25.6% in H1 2025, while Symbravo was launched in June after FDA approval.
Axsome Therapeutics’ (AXSM - Free Report) lead drug, Auvelity (AXS-05), approved for treating major depressive disorder, has witnessed strong sales uptake since its approval and launch. Auvelity, the first approved product in Axsome’s commercial portfolio, currently contributes the majority of the company’s revenues.
Auvelity recorded sales worth $215.9 million in the first half of 2025, reflecting an increase of 82.3% on a year-over-year basis. Auvelity sales are being driven by an increase in unit sales volume and the momentum is likely to continue in the second half of 2025. Our model estimates Auvelity sales to witness a CAGR of around 42.7% in the next three years.
Auvelity is also being developed in several label expansion studies for other central nervous system (CNS) disorders like Alzheimer’s disease (AD), agitation and smoking cessation.
A supplemental new drug application (sNDA) seeking approval for Auvelity to treat AD agitation is expected to be filed with the FDA later in the third quarter of 2025. The company also plans to start a pivotal phase II/III study of Auvelity for treating smoking cessation later in the fourth quarter of 2025.
A potential approval for Auvelity for additional indications is likely to boost sales further and drive growth prospects in the future quarters.
Besides Auvelity, Axsome’s narcolepsy drug, Sunosi (solriamfetol) is also generating incremental sales and aiding the top line. Axsome acquired U.S. rights to Sunosi from Jazz Pharmaceuticals (JAZZ - Free Report) in May 2022.
In the first half of 2025, Sunosi sales increased 25.6% on a year-over-year basis. The acquisition of Sunosi from Jazz diversified the company’s commercial portfolio.
Axsome’s newest product, Symbravo (meloxicam and rizatriptan) was approved by the FDA for the acute treatment of migraine with or without aura in adults in January 2025. The drug, which was launched in the United States in June, further solidified Axsome’s commercial footprint in the target market.
Competition for AXSM in the Target Market
Though Axsome is riding on the success of Auvelity and other commercial activities, competition looms large in the target market as some companies are also developing treatments to address various CNS disorders. Acadia Pharmaceuticals (ACAD - Free Report) is one such company that currently markets its lead drug, Nuplazid (pimavanserin), for a CNS disorder.
ACAD’s Nuplazid was the first and only drug approved by the FDA for hallucinations and delusions associated with Parkinson’s disease psychosis. The ACAD drug recorded sales worth $328.2 million, up 14% year over year, during the first half of 2025.
Sunosi is also likely to face competition from Jazz’s sleep disorder drugs, which hold a strong market share.
Meanwhile, Symbravo will likely encounter competition from established players in the migraine market, including Pfizer’s Nurtec ODT/Vydura and AbbVie’s Ubrelvy and Qulipta/Aquipta. This is likely to induce acute competition for Axsome’s drugs.
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Can Auvelity Drive Axsome's Growth Through the Rest of 2025?
Key Takeaways
Axsome Therapeutics’ (AXSM - Free Report) lead drug, Auvelity (AXS-05), approved for treating major depressive disorder, has witnessed strong sales uptake since its approval and launch. Auvelity, the first approved product in Axsome’s commercial portfolio, currently contributes the majority of the company’s revenues.
Auvelity recorded sales worth $215.9 million in the first half of 2025, reflecting an increase of 82.3% on a year-over-year basis. Auvelity sales are being driven by an increase in unit sales volume and the momentum is likely to continue in the second half of 2025. Our model estimates Auvelity sales to witness a CAGR of around 42.7% in the next three years.
Auvelity is also being developed in several label expansion studies for other central nervous system (CNS) disorders like Alzheimer’s disease (AD), agitation and smoking cessation.
A supplemental new drug application (sNDA) seeking approval for Auvelity to treat AD agitation is expected to be filed with the FDA later in the third quarter of 2025. The company also plans to start a pivotal phase II/III study of Auvelity for treating smoking cessation later in the fourth quarter of 2025.
A potential approval for Auvelity for additional indications is likely to boost sales further and drive growth prospects in the future quarters.
Besides Auvelity, Axsome’s narcolepsy drug, Sunosi (solriamfetol) is also generating incremental sales and aiding the top line. Axsome acquired U.S. rights to Sunosi from Jazz Pharmaceuticals (JAZZ - Free Report) in May 2022.
In the first half of 2025, Sunosi sales increased 25.6% on a year-over-year basis. The acquisition of Sunosi from Jazz diversified the company’s commercial portfolio.
Axsome’s newest product, Symbravo (meloxicam and rizatriptan) was approved by the FDA for the acute treatment of migraine with or without aura in adults in January 2025. The drug, which was launched in the United States in June, further solidified Axsome’s commercial footprint in the target market.
Competition for AXSM in the Target Market
Though Axsome is riding on the success of Auvelity and other commercial activities, competition looms large in the target market as some companies are also developing treatments to address various CNS disorders. Acadia Pharmaceuticals (ACAD - Free Report) is one such company that currently markets its lead drug, Nuplazid (pimavanserin), for a CNS disorder.
ACAD’s Nuplazid was the first and only drug approved by the FDA for hallucinations and delusions associated with Parkinson’s disease psychosis. The ACAD drug recorded sales worth $328.2 million, up 14% year over year, during the first half of 2025.
Sunosi is also likely to face competition from Jazz’s sleep disorder drugs, which hold a strong market share.
Meanwhile, Symbravo will likely encounter competition from established players in the migraine market, including Pfizer’s Nurtec ODT/Vydura and AbbVie’s Ubrelvy and Qulipta/Aquipta. This is likely to induce acute competition for Axsome’s drugs.