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CAMBRIDGE, Mass. - ProMIS Neurosciences Inc. (NASDAQ:PMN), a clinical-stage biotechnology company with a market capitalization of $14.4 million, announced Monday that the U.S. Food and Drug Administration has granted Fast Track designation to its lead Alzheimer’s disease treatment candidate, PMN310. According to InvestingPro data, the company maintains a healthy liquidity position with a current ratio of 3.36x, indicating strong short-term financial stability.
The designation, aimed at accelerating development of therapies addressing serious conditions with unmet medical needs, enables enhanced FDA engagement and potentially streamlines the path to approval for the experimental drug. This development comes as the company’s stock has experienced significant volatility, with InvestingPro data showing a 79% decline over the past year, though analysts maintain optimistic price targets ranging from $3.06 to $8.16.
PMN310 is designed to selectively target toxic oligomers of amyloid-beta while avoiding plaque, which the company believes could reduce the risk of ARIA (amyloid-related imaging abnormalities) - brain swelling and bleeding side effects associated with current Alzheimer’s treatments.
"We designed PMN310 with a goal of providing Alzheimer’s patients with a safer and more efficacious treatment option, which we believe represents the next generation of Alzheimer’s therapeutics," said Neil Warma, President and Chief Executive Officer of ProMIS Neurosciences, in the press release.
The drug is currently being evaluated in the PRECISE-AD Phase 1b clinical trial, a randomized, double-blind, placebo-controlled study examining multiple ascending doses in patients with mild cognitive impairment due to Alzheimer’s and mild Alzheimer’s disease. The trial is assessing 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.
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, according to the company’s statement.
ProMIS Neurosciences is a clinical-stage biotechnology company focused on discovering and developing therapeutic antibodies targeting toxic misfolded proteins in neurodegenerative diseases, including Alzheimer’s, amyotrophic lateral sclerosis, and Parkinson’s disease. The company’s next earnings report is scheduled for August 18, 2025. InvestingPro subscribers have access to over 10 additional key insights about ProMIS, including detailed financial health metrics and growth indicators.
In other recent news, ProMIS Neurosciences Inc. announced it received an additional 180-day extension from the Nasdaq Stock Market to meet the minimum bid price requirement. Initially notified on January 8 for not meeting the $1.00 per share minimum, the company now has until December 29 to comply. This extension allows the company to continue trading on the Nasdaq Capital Market while it considers options like a reverse stock split to address the deficiency. If compliance is not achieved by the deadline, the company may face delisting but can appeal this decision. Separately, during its Annual Meeting, ProMIS Neurosciences approved a new 2025 Stock Option and Incentive Plan, replacing the 2015 Plan for future awards. Shareholders also elected seven directors and ratified Baker Tilly US, LLP as the independent registered public accounting firm for the fiscal year ending December 31, 2025. These developments were disclosed in recent filings with the Securities and Exchange Commission.
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