FDA Grants Fast Track to ProMIS Neurosciences for Alzheimer’s Drug PMN310

ProMIS Neurosciences said the U.S. Food and Drug Administration has granted Fast Track designation to PMN310, its lead monoclonal antibody being developed for Alzheimer’s disease. Fast Track status gives the Cambridge, Massachusetts-based company more frequent interaction with the agency and opens a potential path to Accelerated Approval and Priority Review if future data support those routes. PMN310 is designed to bind only toxic oligomers of amyloid-beta, a strategy the company hopes will reduce amyloid-related imaging abnormalities—brain swelling and micro-hemorrhages—seen with existing plaque-targeting therapies. The drug is being tested in the PRECISE-AD Phase 1b study in patients with mild cognitive impairment or early Alzheimer’s. ProMIS expects six-month biomarker and safety readouts in the second quarter of 2026 and full results in the fourth quarter of the same year. Alzheimer’s affects more than six million people in the United States, and the market for safer, more effective treatments remains highly competitive. While the FDA designation shortens regulatory timelines, PMN310 must still demonstrate safety and efficacy in larger trials before the company can seek marketing approval.