Axsome received FDA approval last week that could open a large new market.
Axsome is looking to turn a new drug acquisition into a treatment for schizophrenia and Tourette syndrome.
Shares of Axsome Therapeutics (NASDAQ: AXSM) have been on a tear, and that just accelerated today. After soaring more than 20% last month, shares of the biopharmaceutical company jumped another 11.1% today, as of 3:10 p.m. ET.
Investors knew the company had just received a new approval from the Food and Drug Administration (FDA) last week. Still, today's first-quarter update provided even more confidence in the company's future potential.
Will AI create the world's first trillionaire? Our team just released a report on the one little-known company, called an "Indispensable Monopoly" providing the critical technology Nvidia and Intel both need. Continue »
Image source: The Motley Fool.
Some big news was already built into Axsome stock. That's the reason shares have been on a tear in recent weeks, hitting new highs. Most recently, its biggest commercial drug was additionally approved by the FDA for the treatment of agitation related to dementia in patients with Alzheimer's disease.
Over 5 million Americans could benefit from Axsome's Auvelity in this regard. Auvelity will be the first with "clean-label status" for this application, and management said the commercial launch is on track for next month.
Today's earnings release brought more good news for biotech investors, too. Last month, Axsome acquired the exclusive global rights to the oral inhibitor balipodect from Takeda Pharmaceuticals. Now dubbed AXS-20, Axsome continues to develop the treatment. In its conference call for investors, management said it plans to set the stage for phase III trials of AXS-20 in Schizophrenia later this year.
That's a short timeline for potential phase III results, and the stock is hitting another new record high today on the growing strength of Axsome's pipeline.
Before you buy stock in Axsome Therapeutics, consider this:
The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Axsome Therapeutics wasn’t one of them. The 10 stocks that made the cut could produce monster returns in the coming years.
Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you’d have $496,473!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you’d have $1,216,605!*
Now, it’s worth noting Stock Advisor’s total average return is 968% — a market-crushing outperformance compared to 202% for the S&P 500. Don't miss the latest top 10 list, available with Stock Advisor, and join an investing community built by individual investors for individual investors.
See the 10 stocks »
*Stock Advisor returns as of May 4, 2026.
Howard Smith has positions in Axsome Therapeutics. The Motley Fool has positions in and recommends Axsome Therapeutics. The Motley Fool has a disclosure policy.