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Investing.com - ProMIS Neurosciences (NASDAQ:PMN) announced the FDA has granted Fast Track designation to its lead Alzheimer’s disease therapeutic candidate PMN310, according to H.C. Wainwright. The micro-cap company, valued at $36.6 million, has seen its shares surge over 154% in the past week, with the stock currently trading at $1.12.
The Fast Track program aims to accelerate therapies addressing serious conditions with unmet medical needs, enabling enhanced FDA engagement and potentially streamlining the approval process for PMN310.
H.C. Wainwright highlighted PMN310’s high in vitro selectivity for toxic beta-amyloid oligomers while avoiding beta-amyloid monomer competition that interferes with other anti-amyloid antibodies’ therapeutic action.
Unlike rival treatments, PMN310 shows no binding to amyloid plaque, which is associated with amyloid-related imaging abnormalities (ARIA) in other antibodies, and high-dose treatment in transgenic mice did not cause microhemorrhages.
The drug preserved memory and learning in Alzheimer’s disease mouse models and was generally well-tolerated in a Phase 1a study with healthy volunteers, with H.C. Wainwright reiterating its Buy rating and 12-month price target of $4. The broader analyst consensus remains bullish, with price targets ranging from $3.07 to $9.49. For more detailed financial analysis and additional ProTips on PMN, visit InvestingPro.
In other recent news, ProMIS Neurosciences Inc. has received Fast Track designation from the U.S. Food and Drug Administration for PMN310, its lead therapeutic candidate for Alzheimer’s disease. This designation aims to expedite the development of therapies for serious conditions with unmet medical needs, potentially streamlining the approval process for PMN310. Additionally, ProMIS Neurosciences has mutually agreed with BTIG, LLC to terminate its At The Market Offering Agreement, which initially allowed the sale of up to $25 million in common shares. The termination comes without any associated penalties, leaving $24.8 million of shares unsold. Furthermore, ProMIS Neurosciences has been granted a 180-day extension by Nasdaq to regain compliance with the minimum bid price requirement. In corporate governance news, the company approved its 2025 Stock Option and Incentive Plan, replacing the 2015 plan, and elected seven directors during its recent annual meeting. The company also ratified Baker Tilly US, LLP as its independent registered public accounting firm for the fiscal year ending December 31, 2025. These developments highlight ProMIS Neurosciences’ strategic adjustments and ongoing clinical advancements.
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