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Investing.com - RBC Capital has reiterated an Outperform rating on Axsome Therapeutics (NASDAQ:AXSM), currently trading at $112.86, with a price target of $189.00. The $5.64 billion market cap company, which boasts impressive gross profit margins of 91%, is drawing attention for its potential approval of AXS-05 drug for Alzheimer’s agitation.
RBC analyst Leonid Timashev pointed to the FDA’s demonstrated flexibility regarding missed endpoints in neuro-psychiatric drugs, particularly for medications with expedited designations, as a key factor supporting the drug’s approval prospects.
The firm specifically noted the regulatory agency’s "clear acceptability for randomized withdrawal trials to support data packages" in its assessment of AXS-05’s regulatory pathway.
RBC believes AXS-05 meets efficacy requirements while showing "substantial safety improvements over standard of care," factors that make approval likely despite mixed clinical data.
The investment bank views Axsome as a buying opportunity, citing a potential $1 billion-plus U.S. market opportunity, possible approval in the first half of 2026, and upside potential of up to 45% from current share levels. According to InvestingPro, analysts maintain a strong buy consensus, with price targets ranging from $144 to $200. Get detailed insights and more exclusive metrics with InvestingPro’s comprehensive research report.
In other recent news, Axsome Therapeutics Inc . reported its second-quarter 2025 earnings, which exceeded Wall Street expectations. The company posted an earnings per share (EPS) of -$0.97, outperforming the forecast of -$1.06. Revenues reached $150 million, surpassing the anticipated $139.31 million. These results highlight a strong financial performance for the quarter. The positive earnings report comes amid other developments in the company. Analysts from various firms have been closely monitoring Axsome Therapeutics, although no specific upgrades or downgrades were noted in the recent updates. Investors are closely watching these developments as they assess the company’s financial health. These recent developments provide a factual basis for understanding Axsome Therapeutics’ current financial standing.
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