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Investing.com - Mizuho (NYSE:MFG) maintained its Outperform rating and $200.00 price target on Axsome Therapeutics (NASDAQ:AXSM), a $5.8 billion market cap company with impressive 91% gross margins, following the company’s disclosure of a generic challenge to its recently launched drug Symbravo. According to InvestingPro data, the stock has delivered a 38% return year-to-date, and analysts maintain a strong buy consensus.
Axsome revealed in an 8-K filing that it received a Paragraph IV Certification Notice Letter from privately held Apotex, which has submitted an abbreviated new drug application seeking approval for a generic version of Symbravo.
The generic application comes just two months after Symbravo’s launch, though Mizuho notes this development isn’t entirely unexpected given the combination nature of Symbravo likely doesn’t qualify for new chemical entity exclusivity.
Mizuho emphasized that Symbravo represents only a minor contributor to Axsome’s revenue potential, limiting the impact of this generic challenge on the company’s overall financial outlook.
The investment firm maintains its positive stance on Axsome partly due to potential upcoming regulatory news for Auvelity/AXS-05 in Alzheimer’s disease agitation, which represents a major area for potential label expansion. Based on InvestingPro’s Fair Value analysis, the stock currently appears to be trading near its fair value.
In other recent news, Axsome Therapeutics reported its second-quarter 2025 earnings, surpassing Wall Street expectations. The company posted an earnings per share of -$0.97, outperforming the forecast of -$1.06. Revenues reached $150 million, exceeding the anticipated $139.31 million. Additionally, Axsome Therapeutics announced it received a Paragraph IV Certification Notice Letter from Apotex Inc. This notice indicates that Apotex has submitted an application to the U.S. Food and Drug Administration to manufacture a generic version of Symbravo. Axsome Therapeutics has stated plans to respond to this notice in due course. Furthermore, RBC Capital reiterated its Outperform rating for the company, with a price target of $189. This confidence is attributed to the FDA’s flexibility regarding missed endpoints in neuro-psychiatric drugs, which supports the approval prospects for Axsome’s AXS-05 drug for Alzheimer’s agitation.
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