Axsome Rallies as FDA Clears Path for Narcolepsy Drug Filing
Shares trade near 52-week highs after positive agency feedback supports a New Drug Application submission for its narcolepsy treatment, AXS-12, planned for early 2026.
Axsome Therapeutics Inc. (NASDAQ: AXSM) saw its shares advance Tuesday, trading near a 52-week peak after the company announced it received supportive feedback from the U.S. Food and Drug Administration (FDA) for its narcolepsy drug candidate, AXS-12.
The New York-based biopharmaceutical firm confirmed in a press release that minutes from a recent pre-New Drug Application (NDA) meeting with the FDA affirm that its existing clinical data package is sufficient for submission. Axsome plans to file the NDA for AXS-12 in January 2026, a significant step toward bringing a new treatment option to patients.
Shares of Axsome have been on a strong upward trend, climbing nearly 76% year-to-date and trading around $149 per share, just shy of its 52-week high of $158.56. The positive regulatory update provides a clearer timeline and de-risks the submission process, fueling investor confidence in the company's expanding pipeline of central nervous system (CNS) therapies. The company currently holds a market capitalization of approximately $7.67 billion.
AXS-12 is an investigational therapy for the treatment of narcolepsy, a chronic neurological condition characterized by excessive daytime sleepiness and cataplexy—a sudden loss of muscle tone. The drug has already been granted Orphan Drug Designation by the FDA, which would provide seven years of market exclusivity if approved. The clinical package for the NDA includes data from three controlled trials and a long-term safety study, which Axsome believes demonstrates the drug's efficacy and safety profile.
"The successful completion of our pre-NDA meeting and the receipt of the official meeting minutes are important milestones in the development of AXS-12," the company stated, signaling its readiness to move forward with the formal application.
Should it gain approval, AXS-12 will enter a competitive but growing market for narcolepsy treatments. It is expected to compete with established therapies such as Jazz Pharmaceuticals' Xyrem and Xywav, as well as newer entrants like Avadel Pharmaceuticals' Lumryz. The successful commercialization of AXS-12 would represent a significant new revenue stream for Axsome, which already markets Auvelity for major depressive disorder and Sunosi for excessive daytime sleepiness.
Wall Street has responded favorably to Axsome's progress. Based on recent analyst ratings, the company has a strong consensus 'Buy' rating, with an average price target of approximately $181, suggesting analysts see further upside from its current trading level. The de-risking of the AXS-12 submission is a key factor in this positive outlook, solidifying a major catalyst for the company's growth trajectory.
Investors will now be watching for the formal NDA submission in early 2026, which will be followed by the FDA's decision on whether to accept the application for review. If accepted, the agency will set a Prescription Drug User Fee Act (PDUFA) target date, marking the deadline for its approval decision and the next major inflection point for Axsome Therapeutics and its novel narcolepsy treatment.