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Investing.com - H.C. Wainwright has reiterated its Buy rating and $180.00 price target on Axsome Therapeutics (NASDAQ:AXSM), currently trading at $117.14, following a generic challenge to the company’s Symbravo medication. The company, with a market capitalization of $5.8 billion, maintains a strong Buy consensus among analysts, with targets ranging from $144 to $200.
Axsome reported on August 19 that it received a Paragraph IV Certification Notice Letter from privately-held generic drugmaker Apotex Inc., which has submitted an Abbreviated New Drug Application to the FDA seeking approval to manufacture a generic version of Symbravo, a meloxicam-rizatriptan benzoate combination. According to InvestingPro data, Axsome has demonstrated impressive revenue growth of 70% and maintains industry-leading gross margins of 91%.
The pharmaceutical company plans to respond to the notice letter, with H.C. Wainwright describing this challenge as "normal course of business in the specialty pharmaceuticals arena." The research firm noted that Apotex has challenged the validity of most, but not all, patents covering Symbravo.
H.C. Wainwright expects Axsome to announce litigation against Apotex, which would trigger an automatic 30-month stay under Hatch-Waxman legislation until the Paragraph IV litigation is resolved. The firm sees "no near-term threat" to Axsome’s Symbravo franchise.
Symbravo is currently protected by patent claims scheduled to expire around 2040, according to H.C. Wainwright, which remains confident the product will "survive generic challenge until late in the lifespan of issued patents protecting its market exclusivity." For deeper insights into Axsome’s financial health and growth prospects, including 8 additional key ProTips, check out the comprehensive analysis available on InvestingPro.
In other recent news, Axsome Therapeutics reported its second-quarter 2025 earnings, surpassing Wall Street expectations. The company posted an earnings per share (EPS) of -$0.97, outperforming the forecast of -$1.06. Revenues reached $150 million, exceeding the anticipated $139.31 million. Axsome also disclosed receiving a Paragraph IV Certification Notice Letter from Apotex Inc., which has submitted an abbreviated new drug application for a generic version of Axsome’s drug Symbravo. The company plans to respond to this notice in due course, as disclosed in a recent SEC filing.
Additionally, Mizuho (NYSE:MFG) maintained its Outperform rating on Axsome, setting a price target of $200.00, despite the generic challenge to Symbravo. Similarly, RBC Capital reiterated its Outperform rating with a price target of $189.00, citing confidence in the potential approval of Axsome’s AXS-05 drug for Alzheimer’s agitation. RBC’s analyst highlighted the FDA’s flexibility regarding missed endpoints in neuro-psychiatric drugs as a supporting factor for the drug’s approval prospects. These developments reflect the company’s current position and future potential.
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