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NeuroSense cut  to Hold at Maxim following PrimeC FDA feedback
The Fly

NeuroSense cut to Hold at Maxim following PrimeC FDA feedback

Maxim downgraded NeuroSense (NRSN) to Hold from Buy. The firm cites the company having received feedback from the FDA regarding the Phase trial 3 design for PrimeC to treat amyotrophic lateral sclerosis, stating that based on its review, it is now unlikely NeuroSense pursues an Accelerated Approval filing pathway for a U.S. New Drug Application in 2025, the analyst tells investors in a research note. While the data previously generated for PrimeC has been promising and NeuroSense has access to an Equity Purchase Agreement, the company still has capital constraints, including its “baby shelf” limitations, which will make it difficult to raise sufficient capital to fully finance the Phase 3 trial, the firm adds.

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