The FDA has already accepted the company’s application seeking the greenlight for AXS-12.
- The company is on track to start a mid-to-late stage trial of AXS-05 for smoking cessation this quarter and other key trials in the months ahead.
- For Q2, the company reported revenue below Wall Street estimates.
- AUVELITY, Axsome’s main drug, however, continues to garner more prescriptions.
Shares of Axsome Therapeutics (AXSM) advanced about 5% on Monday, as investors largely overlooked a modest miss on revenue and a wider-than-expected loss, focusing instead on robust commercial momentum and multiple near-term pipeline catalysts.
Earlier today, Axsome reported second-quarter net product revenue of $218.4 million, a 46% year-over-year increase driven by AUVELITY sales of $180.3 million, though below a Wall Street estimate of $221.78 million. The company posted a net loss of $51.3 million, or $0.99 per share, above an estimated loss of $0.84 per share. Cash stood at approximately $320 million at the end of the quarter.
Near-Term Catalysts in Focus
Axsome is advancing multiple programs with near-term milestones. “Our broad late-stage neuroscience pipeline positions us to potentially file on average one new NDA (new drug application) each year between now and 2030,” CEO Herriot Tabuteau said.
The company is on track to start a mid-to-late stage trial of AXS-05 for smoking cessation this quarter. Top-line results from the ENGAGE late-stage trial of solriamfetol in binge eating disorder are expected in the fourth quarter. FOCUS-2 and FOCUS-3 ADHD studies in children and adolescents recently began, and the FORWARD late-stage for AXS-14 in fibromyalgia continues to enroll.
The FDA has already accepted the company’s application seeking the green light for AXS-12 for the treatment of cataplexy in narcolepsy. The agency will decide on the application by May 1, 2027.
Continued Commercial Momentum Driven By Auvelity
AUVELITY, Axsome’s main drug, was first approved as a treatment for major depression. In the second quarter, the company also began selling it for a second use: reducing agitation in people living with Alzheimer’s disease.
Early numbers from the first eight weeks of that Alzheimer’s launch look promising, the company said. Doctors wrote about 266,000 prescriptions for AUVELITY in the quarter—34% more than a year earlier. The company has hired more sales representatives and negotiated broader insurance coverage, and it expects these steps to keep pushing prescriptions higher in the third and fourth quarters.
Demand for SYMBRAVO, Axsome’s other drug for migraine headaches, rose 30% from the first quarter to the second. SUNOSI, which helps people who suffer from excessive daytime sleepiness caused by narcolepsy or obstructive sleep apnea, continues to grow faster than other drugs in the same category, it added.
How Did AXSM Retail Traders React?
On Stocktwits, retail sentiment around AXSM stock rose from bullish to extremely bullish territory over the past 24 hours, while message volume increased from normal to high levels.
A Stocktwits user expressed optimism about the stock in light of Auvelity’s increasing adoption.
Another voiced hopes for the stock breaching the $300 mark now.
AXSM stock has gained 22% year-to-date.
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