FDA accepts Axsome's NDA for AXS-12 in narcolepsy cataplexy

Axsome Therapeutics announced on July 15, 2026 that the FDA has accepted for filing the company's New Drug Application for AXS-12 (reboxetine) for the treatment of cataplexy in narcolepsy.¹

The agency has set a Prescription Drug User Fee Act target action date of May 1, 2027.¹ Axsome also said the FDA indicated that it does not currently plan to hold an advisory committee meeting to discuss the application.¹

Cataplexy is a hallmark symptom of narcolepsy. According to the company, it affects roughly 70% of patients with the condition, appearing as an abrupt loss of muscle control while a person is awake, often set off by intense emotional reactions like laughing or feeling scared, angry, stressed, or excited, as described in the release's "About Narcolepsy"¹ section.

AXS-12 is described as a highly selective and potent norepinephrine reuptake inhibitor and cortical dopamine modulator under development for the treatment of narcolepsy.¹ The company's proposed mechanism involves the drug acting on noradrenergic pathways to help sustain muscle tone during waking hours, while also engaging noradrenergic and dopaminergic signaling in the cortex to support alertness and mental function, as outlined in the release's "About AXS-12"¹ discussion.

The FDA has previously granted the drug candidate Orphan Drug Designation for the treatment of narcolepsy.¹ Axsome noted that AXS-12 is not approved by the FDA.¹

The disclosure was filed as an 8-K, with the press release attached as Exhibit 99.1 and signed by CEO Herriot Tabuteau, M.D.