- ProMIS Neurosciences (NASDAQ:PMN), a clinical-stage biotech stock focused on neurodegenerative diseases, has been granted the U.S. Food and Drug Administration’s Fast-Track Designation for PMN310, its lead monoclonal antibody treatment for Alzheimer’s disease
- The treatment is designed to offer a more targeted response compared to legacy options, reducing common side effects including brain swelling and bleeding known as amyloid-related imaging abnormalities (ARIA)
- ProMIS is a clinical-stage biotechnology stock focused on developing treatments against neurodegenerative and other misfolded protein diseases
- The Alzheimer’s stock is up by 213.70 per cent on the news trading at US$1.38 as of 11:04 am ET, but has given back 28.47 per cent year-over-year and 85.15 per cent since 2020
ProMIS Neurosciences (NASDAQ:PMN), a clinical-stage biotech stock focused on neurodegenerative diseases, has been granted the U.S. Food and Drug Administration’s (FDA) Fast-Track Designation for PMN310, its lead monoclonal antibody treatment for Alzheimer’s disease.
This content has been prepared in collaboration with ProMIS Neurosciences Inc., and is intended for informational purposes only.
The treatment is designed to offer a more targeted response compared to legacy options, reducing common side effects including brain swelling and bleeding known as amyloid-related imaging abnormalities (ARIA).
The designation expedites therapeutic development for serious conditions through easier access to the FDA, de-risking PMN310’s path to market, which the Alzheimer’s Association estimates at 7 million patients in the U.S. alone.
PMB310 showed early promise in a phase 1a trial, demonstrating favorable safety and tolerance profiles, in addition to an efficient crossing of the blood-brain barrier in healthy volunteers.
ProMIS’ ongoing PRECISE-AD phase 1b trial is studying the effects of PMN310 in patients with early Alzheimer’s disease, with eyes on characterizing safety, tolerability, pharmacokinetics and disease-relevant biomarkers. Interim six-month biomarker reporting is expected in Q2 2026 followed by final results in Q4.
Leadership insights
“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 towards key clinical milestones,” Neil Warma, ProMIS Neurosciences’ president and chief executive officer, said in a statement. “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. By selectively targeting only the most harmful, toxic forms of amyloid-beta, we believe PMN310 has the potential to reduce the serious side effects seen with current Alzheimer’s treatments, namely brain swelling and bleeding known as ARIA, while also delivering improved therapeutic benefit to patients.”
About ProMIS Neurosciences
ProMIS is a clinical-stage biotechnology stock focused on developing treatments against neurodegenerative and other misfolded protein diseases.
The Alzheimer’s stock (NASDAQ:PMN) is up by 213.70 per cent on the news trading at US$1.38 as of 11:04 am ET. The stock has given back 28.47 per cent year-over-year and 85.15 per cent since 2020.
Join the discussion: Find out what investors are saying about this Alzheimer’s stock on the ProMIS Neurosciences Inc. Bullboard and check out the rest of Stockhouse’s stock forums and message boards.
Stockhouse does not provide investment advice or recommendations. All investment decisions should be made based on your own research and consultation with a registered investment professional. The issuer is solely responsible for the accuracy of the information contained herein. For full disclaimer information, please click here.
