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Axsome Therapeutics, Inc. (NASDAQ:AXSM), a pharmaceutical company with a market capitalization of $5.8 billion and impressive year-to-date gains of 31.5%, announced it received a Paragraph IV Certification Notice Letter from Apotex Inc. on Tuesday. The notice states that Apotex has submitted an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration seeking approval to manufacture, use, or sell a generic version of Symbravo (meloxicam-rizatriptan benzoate).
Axsome Therapeutics indicated it plans to respond to the notice letter in due course. The company made the disclosure in a statement based on a recent SEC filing. According to InvestingPro, the company maintains impressive gross profit margins of 91.5% and has shown strong revenue growth of nearly 70% in the last twelve months.
Symbravo is a branded pharmaceutical product marketed by Axsome Therapeutics. The Paragraph IV notice is a procedural step that allows a generic drug maker to challenge the patents covering an approved branded drug.
The information in this article is based on a press release statement and the company’s filing with the Securities and Exchange Commission.
In other recent news, Axsome Therapeutics reported its second-quarter 2025 earnings, exceeding Wall Street expectations. The company posted an earnings per share of -$0.97, outperforming the projected -$1.06. Revenues for the quarter reached $150 million, surpassing the anticipated $139.31 million. Additionally, RBC Capital has reiterated its Outperform rating on Axsome Therapeutics, maintaining a price target of $189.00. The rating reflects confidence in the potential approval of Axsome’s AXS-05 drug for Alzheimer’s agitation. RBC analyst Leonid Timashev cited the FDA’s demonstrated flexibility with neuro-psychiatric drugs as a supportive factor for the drug’s approval prospects. These developments provide investors with insights into Axsome’s recent performance and future outlook.
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