ProMIS Neurosciences Inc. (Nasdaq:PMN), a clinical-stage biotechnology firm specializing in treatments for neurodegenerative diseases, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its lead therapeutic candidate, PMN310, for the treatment of Alzheimer’s disease (AD).
PMN310 is a humanized monoclonal antibody designed to selectively target toxic oligomers of amyloid-beta, a hallmark of Alzheimer’s pathology, while avoiding plaque binding—a key feature believed to reduce the risk of side effects such as brain swelling and bleeding (ARIA) that are common with current amyloid therapies.
The FDA’s Fast Track designation aims to expedite the development of drugs that treat serious conditions and address unmet medical needs. This status provides ProMIS with opportunities for more frequent interactions with the FDA and a potentially accelerated path to market approval.
“This is a pivotal moment for ProMIS and the Alzheimer’s community,” said Neil Warma, President and CEO of ProMIS Neurosciences. “Fast Track status not only validates the therapeutic promise of PMN310, but also strengthens our ability to advance this drug through clinical development with greater regulatory support.”
The drug is currently being tested in the ongoing PRECISE-AD Phase 1b trial, which is evaluating safety, tolerability, pharmacokinetics, and effects on disease-relevant biomarkers in patients with early-stage Alzheimer’s. Interim six-month biomarker and safety data are expected in Q2 2026, with final trial results anticipated by Q4 2026.
Alzheimer’s disease affects more than six million people in the United States alone and remains one of the leading causes of death and disability among older adults. Despite recent advances, the need for safer and more targeted therapies remains urgent.
The PRECISE-AD study is the first clinical trial designed to assess a monoclonal antibody that selectively binds only toxic amyloid-beta oligomers. The randomized, double-blind, placebo-controlled study includes multiple ascending intravenous doses (5, 10, 20 mg/kg) in patients with Mild Cognitive Impairment and early-stage AD. The trial is also designed to rigorously assess whether PMN310’s unique mechanism can significantly lower ARIA risk while providing clinical benefit.
About ProMIS Neurosciences
ProMIS Neurosciences is a clinical-stage biotech company developing antibody-based therapies to target misfolded proteins implicated in Alzheimer’s, ALS, Parkinson’s, and other neurodegenerative diseases. Its proprietary EpiSelect™ platform enables the identification of Disease Specific Epitopes (DSEs), allowing for highly selective and potentially safer treatments. The company operates out of Cambridge, Massachusetts, and Toronto, Ontario.
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