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Investing.com -- ProMIS Neurosciences Inc (NASDAQ:PMN) stock surged 145% after the company announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its lead Alzheimer’s disease treatment candidate, PMN310.
The Fast Track designation, designed to expedite development of therapies addressing serious conditions with unmet medical needs, will provide ProMIS with enhanced FDA engagement opportunities and potentially a more efficient path to approval for PMN310.
"This is a pivotal moment for ProMIS and the Alzheimer’s community, as receiving Fast Track designation not only underscores the potential of PMN310 to address a critical unmet need, but also provides valuable opportunities for regulatory insight as we advance toward key clinical milestones," said Neil Warma, President and Chief Executive Officer of ProMIS Neurosciences.
The company’s PMN310 therapeutic candidate is currently being evaluated in the PRECISE-AD Phase 1b trial in patients with early Alzheimer’s disease. The study focuses on safety, tolerability, pharmacokinetics, and disease-relevant biomarkers. ProMIS expects to report interim six-month biomarker and safety data in the second quarter of 2026, with final results anticipated in the fourth quarter of 2026.
PMN310 was designed to selectively target only the toxic forms of amyloid-beta, which the company believes could reduce serious side effects seen with current Alzheimer’s treatments, such as ARIA (brain swelling and bleeding), while potentially delivering improved therapeutic benefits.
Alzheimer’s disease affects more than 6 million people in the United States and remains a leading cause of death and disability among older adults.
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