Axsome Settles Patent Litigation with Alkem over SUNOSI
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 2 days ago
0mins
Should l Buy AXSM?
Axsome Therapeutics entered into a settlement agreement with Alkem Laboratories resolving patent litigation related to Axsome's product SUNOSI. The litigation, which is pending in the United States District Court for the District of New Jersey, resulted from submission by Alkem of an Abbreviated New Drug Application to the U.S. Food and Drug Administration seeking approval to market a generic version of SUNOSI in the United States. Under the terms of the settlement agreement, Axsome will grant Alkem a license to sell its generic version of SUNOSI beginning on or after September 1, 2040, if pediatric exclusivity is granted for SUNOSI, or on or after March 1, 2040, if no pediatric exclusivity is granted, subject to FDA approval and conditions and exceptions customary for agreements of this type. As required by law, Axsome and Alkem will submit the settlement agreement to the U.S. Federal Trade Commission and the U.S. Department of Justice for review. Similar patent litigation brought by Axsome against another party related to SUNOSI remains pending in the U.S. District Court for the District of New Jersey.
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Analyst Views on AXSM
Wall Street analysts forecast AXSM stock price to rise
15 Analyst Rating
14 Buy
1 Hold
0 Sell
Strong Buy
Current: 183.300
Low
153.00
Averages
209.54
High
260.00
Current: 183.300
Low
153.00
Averages
209.54
High
260.00
About AXSM
Axsome Therapeutics, Inc. is a biopharmaceutical company. The Company is focused on the development and commercialization of medicines for people living with central nervous system (CNS) conditions. The Company's commercial products include Auvelity, Sunosi and Symbravo. It is also advancing a diversified, late-stage pipeline of product candidates for serious neurological and psychiatric conditions, which include AXS-05, AXS-12, AXS-14 and AXS-17. Auvelity (dextromethorphan-bupropion) is an oral, N-methyl-D-aspartate (NMDA) receptor antagonist with multimodal activity indicated for the treatment of major depressive disorder (MDD). Sunosi (solriamfetol) is an oral medication indicated for the treatment of excessive daytime sleepiness (EDS), in patients with narcolepsy or obstructive sleep apnea. Symbravo (meloxicam and rizatriptan, 20 mg/10mg tablets) is an oral, single-dose medicine approved for the acute treatment of migraine with or without aura in adults.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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See More
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- Technical Pattern: The stock is forming a three-weeks-tight pattern, suggesting a cautious attitude among investors as they await earnings, which may indicate impending volatility in the stock price.
- Earnings Expectations: With the earnings report approaching, the market is optimistic about Axsome's profitability and future growth potential, with analysts generally positive about the performance of its product line.
- Investor Sentiment: Pre-earnings, investor sentiment appears to be bullish, potentially driving the stock price higher in the short term, reflecting confidence in the company's strategic direction.
See More
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- Regulatory Catalyst: On December 31, 2025, Axsome's Alzheimer's drug AXS-05 received priority review, with a target action date set for April 30, 2026; the stock jumped 23% on the news, reflecting high market anticipation for the drug's approval.
- Investment Risk Warning: Despite a market cap of $9.4 billion, Axsome remains unprofitable and trades at a high price-to-sales ratio of 16, prompting investors to carefully assess risks, especially given the greater impact of regulatory news on stock price than earnings results.
See More
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- Strong Sales Growth: Axsome Therapeutics reported third-quarter revenue of $171 million, reflecting a 63% year-over-year increase, indicating robust market demand for its drug portfolio, particularly with newly approved products like Symbravo and Auvelity, which are expected to sustain revenue growth.
- New Drug Approval Prospects: The company is pursuing a label expansion for Auvelity in treating Alzheimer's disease (AD) agitation, having shown promising results in phase 3 trials; FDA approval could significantly enhance revenue potential.
- Multiple Clinical Trials Underway: Sunosi has completed a phase 3 study for adults with ADHD, and Axsome plans to conduct further trials in areas like depression with daytime sleepiness, which are anticipated to create new revenue streams for the company.
- Vast Market Opportunities: With over 5 million patients suffering from AD agitation in the U.S. and only one FDA-approved treatment available, Axsome's potential sales in this market could reach billions, highlighting significant growth prospects ahead.
See More
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- High Demand for Call Options: Notably, the $90 strike call option expiring on February 20, 2026, saw 1,031 contracts traded today, representing around 103,100 shares, suggesting an increased investor expectation for CommVault's stock price appreciation.
- Axsome Options Volume: Axsome Therapeutics Inc recorded an options trading volume of 7,271 contracts, equating to approximately 727,100 shares, or about 81.4% of its average daily trading volume over the past month, reflecting strong market confidence in its growth potential.
- Strong Performance of Call Options: Particularly, the $280 strike call option expiring on April 17, 2026, traded 5,527 contracts today, representing approximately 552,700 shares, indicating optimistic investor sentiment regarding Axsome's future performance.
See More
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- Financial Model Update: Baird increased Axsome's price target from $157 to $209 based on an update to its financial model following preliminary Q4 2025 results that slightly exceeded expectations, further boosting market confidence.
- Sales Beat Expectations: Wells Fargo raised Axsome's price target from $157 to $193, noting that Q4 2025 sales for Auvelity and Sunosi surpassed consensus estimates, which is expected to drive continued positive momentum for the stock.
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See More
