Axsome Banks on Auvelity & Sunosi to Fuel Growth

Axsome Therapeutics' AXSM first marketed drug, Auvelity (AXS-05), was launched in the United States in 2022 for the treatment of major depressive disorder, making it the first approved drug in the company's portfolio.

The drug generated sales worth $118.4 million in the first half of 2024, up 172.8% year over year, owing to strong underlying demand. The momentum is likely to continue for the remainder of 2024.

Axsome is also conducting several label expansion studies on Auvelity targeting other central nervous system disorders like Alzheimer's disease (AD) associated agitation and smoking cessation.

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.

AXSM 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 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.

The acquisition of Sunosi from Jazz diversified Axsome's portfolio to two marketed drugs. 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.

In February 2023, AXSM entered into a licensing agreement with Pharmanovia to market Sunosi in Europe and certain Middle East/North African countries. Axsome receives royalties on Sunosi sales in out-licensed territories.

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. After several delays, the company resubmitted its NDA for AXS-07 to the FDA for the acute treatment of migraine in the second quarter of 2024. A decision from the regulatory body is expected within six months.

Though Axsome is riding on the success of Auvelity and Sunosi, competition looms large on the company in the target market as many companies are developing treatments to address various CNS disorders. One such company is Acadia Pharmaceuticals ACAD, 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 also studying pimavanserin for the treatment of other CNS disorders.

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