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Axsome Therapeutics’ Strategic Response to FDA Feedback Supports Buy Rating

Axsome Therapeutics’ Strategic Response to FDA Feedback Supports Buy Rating

Ami Fadia, an analyst from Needham, maintained the Buy rating on Axsome Therapeutics (AXSMResearch Report). The associated price target was lowered to $150.00.

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Ami Fadia has given his Buy rating due to a combination of factors related to Axsome Therapeutics’ strategic response to regulatory feedback. Despite receiving a refusal to file letter from the FDA for its AXS-14 NDA in fibromyalgia, the company is proactively addressing the issue by planning an additional controlled trial to meet the FDA’s requirements.
This decision reflects management’s commitment to advancing their pipeline and aligns with the expectation of initiating the new trial in the fourth quarter of 2025. Consequently, while the launch timing has been adjusted and the probability of success has been revised, the overall outlook remains positive, supporting the Buy rating.

In another report released on June 6, Morgan Stanley also maintained a Buy rating on the stock with a $190.00 price target.

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