Axsome Therapeutics (AXSM) received a Refusal to File letter by the FDA’s Division of Anesthesiology, Addiction Medicine, and Pain Medicine regarding AXS-14, with the division finding the new drug application to be incomplete given one of the two trials in Axsome’s regulatory filing used a flexible-dose schedule with an 8-week endpoint, Morgan Stanley analyst Vikram Purohit tells investors in a research note. An additional trial exploring a fixed-dose regimen with a 12-week primary endpoint will begin in Q4, the firm says. Morgan Stanley, which has an Overweight rating and $190 price target on the shares, continues to see the commercial trajectory of Auvelity in major depressive disorder and regulatory progress with AXS-05 in Alzheimer’s disease agitation as the key drivers of Axsome for 2025.
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