FDA Neurology Roundup: July 2026

This roundup highlights several FDA actions in July related to therapeutics for neurologic illness. For information on approvals in other specialties during 2026, see Medscape Medical News’ FDA Drug Approvals page.Panel Votes Against Deramiocel for Duchenne Muscular Dystrophy (DMD)-Related CardiomyopathyAn FDA advisory committee voted 9-3 that available evidence does not support the effectiveness of deramiocel (Capricor Therapeutics) for DMD-associated cardiomyopathy. FDA reviewers found no significant treatment effect in the phase 3 HOPE-3 trial using the agency’s preferred analysis, a finding Capricor disputes. If approved, deramiocel would be the first therapy for DMD-associated cardiomyopathy, a leading cause of mortality in this disease.First Over-the-Counter (OTC) Acetaminophen-Naproxen Combination for Pain Relief ApprovedThe FDA approved Tylenol with naproxen (acetaminophen 325 mg/naproxen sodium 110 mg, Kenvue), the first fixed-dose OTC combination of the two pain relievers in a single tablet, providing up to 12 hours of relief. Approved for adults and children aged 12 years or older, the product carries standard acetaminophen and nonsteroidal anti-inflammatory drug warnings, including risks for liver damage, stomach bleeding, and cardiovascular events.Priority Review for Antisense Oligonucleotide (ASO) Therapy for Exon 51 DMDThe FDA accepted the Biologics License Application (BLA) for zeleciment rostudirsen (DYNE-251, Dyne Therapeutics), an investigational ASO therapy for patients with DMD amenable to exon 51 skipping, and granted priority review, the company announced. The application seeks accelerated approval based on dystrophin expression and is supported by phase 1/2 DELIVER trial data showing increased dystrophin production and functional improvements across multiple clinical endpoints.Norepinephrine Reuptake Inhibitor (NRI) Advances for Narcolepsy With CataplexyThe FDA accepted the New Drug Application (NDA) for AXS-12 (reboxetine, Axsome Therapeutics) for the treatment of cataplexy in narcolepsy. The NDA is supported by results from the phase 3 SYMPHONY trial, which showed the NRI and cortical dopamine modulator was safe and effective in patients with narcolepsy and cataplexy. AXS-12 has Orphan Drug designation, and the FDA does not currently plan to hold an advisory committee meeting on the application.Investigational Oral Therapy for Obstructive Sleep Apnea (OSA) Moves ForwardThe FDA accepted the NDA for AD109 (aroxybutynin/atomoxetine, Apnimed), an investigational once-nightly oral therapy for adults with OSA. The application is supported by two phase 3 trials showing significant reductions in apnea-hypopnea index and improved oxygenation in patients who did not respond to or declined positive airway pressure therapy. If approved, AD109 would be the first oral pharmacologic therapy for OSA.FDA OK’s Subcutaneous Lecanemab for Early Alzheimer’s DiseaseThe agency approved a supplemental BLA for a once-weekly subcutaneous formulation of lecanemab-irmb (Leqembi Iqlik, Eisai and Biogen) as an initiation dose for adults with early Alzheimer’s disease. The approval allows patients to start and continue treatment entirely at home using an autoinjector, eliminating the need for intravenous infusions. Lecanemab was previously approved for at-home subcutaneous maintenance dosing only after an initial period of intravenous treatment.