William Blair analyst Myles Minter has reiterated their bullish stance on AXSM stock, giving a Buy rating today.
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Myles Minter has given his Buy rating due to a combination of factors tied to Axsome’s late-stage pipeline and regulatory momentum. He views the FDA’s acceptance of the supplemental filing for Auvelity in Alzheimer’s agitation, together with priority review and prior breakthrough designation, as signaling a constructive regulatory stance on the strength and approvability of the data. While one of the key trials did not meet its primary endpoint, he emphasizes that the broader clinical package is compelling and aligns with precedents where central nervous system drugs, including Rexulti, have been cleared on mixed but overall supportive efficacy and safety profiles.
Minter also highlights that the FDA’s priority review underscores the sizable unmet need in Alzheimer’s-related agitation, particularly given limitations and safety concerns with existing options. He assigns a high probability of approval—about 85%—for Auvelity in this indication and projects peak sales exceeding $2 billion, which would significantly broaden the franchise beyond its current use in major depressive disorder. In addition, Axsome’s plan to submit an NDA for AXS-12 in narcolepsy following a favorable pre-filing meeting adds another potential value driver, reinforcing his positive outlook on the company’s growth prospects.
In another report released today, Needham also reiterated a Buy rating on the stock with a $169.00 price target.