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Axsome secures long-term SUNOSI exclusivity through Alkem settlement

Story Highlights
  • Axsome’s settlement with Alkem sets generic SUNOSI entry no earlier than 2040.
  • The deal extends SUNOSI’s exclusivity but faces regulatory review and ongoing related litigation.
  • Looking for the best stocks to buy? Follow the recommendations of top-performing analysts.
Axsome secures long-term SUNOSI exclusivity through Alkem settlement

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Axsome Therapeutics ( (AXSM) ) has provided an announcement.

On February 17, 2026, Axsome Therapeutics announced a settlement agreement with Alkem Laboratories resolving patent litigation over SUNOSI, its solriamfetol‑based therapy, stemming from Alkem’s Abbreviated New Drug Application to market a generic in the U.S. Under the deal, Axsome will license Alkem to sell a generic SUNOSI on or after September 1, 2040, if pediatric exclusivity is granted, or March 1, 2040, if it is not, contingent on U.S. Food and Drug Administration approval and customary conditions.

The agreement, which must be reviewed by the U.S. Federal Trade Commission and Department of Justice, secures a long runway of market exclusivity for SUNOSI while formalizing the eventual entry of an authorized generic competitor. Similar SUNOSI‑related patent litigation with another party remains pending in the U.S. District Court for the District of New Jersey, leaving additional intellectual property questions outstanding for stakeholders.

The most recent analyst rating on (AXSM) stock is a Buy with a $219.00 price target. To see the full list of analyst forecasts on Axsome Therapeutics stock, see the AXSM Stock Forecast page.

Spark’s Take on AXSM Stock

According to Spark, TipRanks’ AI Analyst, AXSM is a Neutral.

The score is primarily restrained by weak financial quality—ongoing losses, negative operating/free cash flow, and high leverage—despite very strong gross margins and revenue growth. Technicals and recent company updates (strong revenue momentum and regulatory/pipeline progress) are supportive, but valuation remains pressured by unprofitability.

To see Spark’s full report on AXSM stock, click here.

More about Axsome Therapeutics

Axsome Therapeutics, Inc. is a biopharmaceutical company focused on central nervous system disorders, developing differentiated medicines with novel mechanisms of action. Its neuroscience portfolio includes FDA‑approved treatments for major depressive disorder, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, as well as multiple late‑stage programs targeting serious neurological and psychiatric conditions in the U.S.

The company aims to address large unmet needs in brain health, serving more than 150 million affected patients domestically through both commercialized products and an advancing clinical pipeline.

Average Trading Volume: 638,429

Technical Sentiment Signal: Buy

Current Market Cap: $9.14B

Find detailed analytics on AXSM stock on TipRanks’ Stock Analysis page.

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