Shares of Axsome Therapeutics AXSM jumped 20.2% on Monday after the company announced that it has entered into a settlement agreement with Teva Pharmaceuticals TEVA related to patents for the psychiatry drug, Auvelity.

The settlement agreement resolves the patent litigation brought by Axsome on Teva for submitting an abbreviated new drug application to the FDA, seeking marketing approval for a generic version of Auvelity in the United States before applicable patents expire.

Auvelity is approved for the treatment of adults with major depressive disorder (“MDD”). It is the first approved drug in Axsome’s portfolio. Auvelity was launched in the United States in 2022. The company is conducting several label expansion studies on Auvelity targeting other central nervous system disorders like Alzheimer’s disease (“AD”) associated with agitation and smoking cessation.

In the past three months, shares of Axsome have surged 27.7% against the industry’s 7.8% decline.

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AXSM’s Litigation Settlement Terms With TEVA in Details

Per the settlement terms, Axsome will grant Teva a license to sell a generic version of Auvelity in the United States, subject to approval and other customary conditions, on or after Sept. 30, 2038. However, if pediatric exclusivity is granted for Auvelity, the launch of Teva’s generic version will be delayed until or after March 31, 2039. Axsome and Teva will end all ongoing patent litigation over Auvelity patents in the U.S. District Court in New Jersey.

Per AXSM, the settlement agreement resolves all outstanding patent litigation relating to Auvelity. Axsome and Teva are required to submit the settlement agreement for review by the U.S. Federal Trade Commission and the U.S. Department of Justice, as mandated by law.

TEVA Settlement is a Huge Win for AXSM

This is a huge win for Axsome. It protects the company’s Auvelity sales from generic erosion in the U.S. market for MDD treatment. The drug is the primary top-line driver for AXSM. In the first nine months of 2024, the drug generated sales worth $198.8 million, driven by an increase in unit sales volume which indicates a rise of 145.4% year over year in the United States. Auvelity sales accounted for 75% of the company’s net product revenues recognized during the same period.

Last month, Axsome reported robust preliminary net-product revenues for Auvelity and narcolepsy drug, Sunosi, for the fourth quarter and full-year 2024. Auvelity sales in the fourth quarter of 2024 are expected to be around $92.6 million, bringing the full-year number to around $291.4 million. Sunosi’s net-product revenues are expected to be around $25.7 million and $93.8 million for the fourth quarter and full-year 2024, respectively. 

Axsome is also currently gearing up to submit a new drug application for AXS-05 in AD agitation to the FDA in the second half of 2025, based on efficacy and safety data from two separate phase III studies, evaluating the candidate for treating agitation associated with the same.

Axsome Therapeutics, Inc. Price and Consensus

Axsome Therapeutics, Inc. price-consensus-chart | Axsome Therapeutics, Inc. Quote

AXSM's Zacks Rank & Stocks to Consider

Axsome currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks from the sector are BioMarin Pharmaceutical BMRN and Alnylam Pharmaceuticals ALNY, each currently carryinga Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 (Strong Buy) Rank stocks here.

In the past 30 days, estimates for BioMarin Pharmaceutical’s 2024 earnings per share have increased from $3.28 to $3.29. Estimates for 2025 earnings per share have remained constant at $4.01 during the same timeframe. In the past three months, BioMarin Pharmaceutical shares have lost 4%.

BMRN’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 28.7%.

In the past 30 days, estimates for Alnylam Pharmaceuticals’ 2024 loss per share have remained constant at 39 cents. The estimate for 2025 earnings per share is currently pegged at 41 cents. In the past three months, shares of Alnylam Pharmaceuticals have gained 1.9%.

ALNY’s earnings beat estimates in three of the trailing four quarters and matched once, delivering an average surprise of 65.67%.

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