Axsome Hits 52-Week High After Surging Nearly 5%--FDA Milestones Could Fuel Even Bigger Gains

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Axsome Therapeutics (NASDAQ:AXSM) just hit a 52-week, skyrocketing more than 55% over the past year. What's driving the surge? Simple: a red-hot pipeline and big wins on the regulatory front. Investors are all-in on Axsome's potential, especially with FDA action dates looming. AXS-07, the migraine fighter, could get the green light by the beginning of 2025, and Phase 3 trial results for AXS-05 in Alzheimer's agitation are set to drop this quarter. Throw in Auvelity, their antidepressant, smashing sales with a jaw-dropping 113% year-over-year growth, and you've got the kind of momentum that turns heads on Wall Street.

The numbers don't just impressthey stun. Axsome raked in $104.8 million in Q3 revenue, an 81% jump year-over-year. Their gross profit margin? A sizzling 90.3%. With $327.3 million in cash and plans to expand Auvelity's sales force again in 2025, Axsome is setting itself up to dominate. Analysts are bullish too. Mizuho doubled down on their Outperform rating with a $106 price target, pointing to the company's knack for hitting both scientific and commercial milestones.

Looking ahead, it's clear the best might still be coming. Axsome has nine late-stage clinical programs targeting CNS disorders like narcolepsy, fibromyalgia, and ADHD. Key trial results and regulatory decisions are just around the corner, and CEO Herriot Tabuteau is confident about delivering new therapies to millions of patients. The takeaway? Axsome isn't just winning nowit's building a foundation for sustained growth that could deliver big returns for investors willing to ride this wave.

This article first appeared on GuruFocus.