Axsome Therapeutics’ Growth Prospects Remain Strong Despite FDA Setback on AXS-14

William Blair analyst Myles Minter has reiterated their bullish stance on AXSM stock, giving a Buy rating today.

Myles Minter’s rating is based on the understanding that the recent FDA refusal to file Axsome Therapeutics’ NDA for AXS-14 due to trial design issues does not significantly alter the company’s growth prospects. The refusal was primarily due to the need for an additional placebo-controlled, 12-week fixed-dose study, which Axsome plans to initiate by the fourth quarter of 2025. Importantly, the FDA’s concerns were not related to the efficacy of the study data, which met all primary endpoints.
Minter acknowledges that while the delay in the AXS-14 program is unfortunate, it only slightly impacts the overall valuation of the company. The focus remains on other promising areas of Axsome’s pipeline, such as the sNDA submission for Alzheimer’s disease agitation, which is progressing as planned. This strategic focus on other growth avenues supports the Buy rating, as Axsome’s broader portfolio continues to present significant potential for future success.

According to TipRanks, Minter is a 4-star analyst with an average return of 6.9% and a 47.32% success rate. Minter covers the Healthcare sector, focusing on stocks such as Axsome Therapeutics, Arcturus Therapeutics, and Biogen.

In another report released today, TD Cowen also maintained a Buy rating on the stock with a $190.00 price target.