CervoMed Announces Orphan Drug Designation Granted to Neflamapimod by U.S. Food and Drug Administration for the Treatment of Frontotemporal Dementia
CervoMed (NASDAQ: CRVO) announced that its oral drug neflamapimod received Orphan Drug Designation from the FDA for treating frontotemporal dementia (FTD).
The designation applies to therapies for rare diseases affecting fewer than 200,000 people in the US and provides benefits including tax credits, development assistance, and seven years of marketing exclusivity.
The company is preparing for a Phase 3 trial in dementia with Lewy bodies (DLB) in mid-2025 and expects topline data from the RewinD-LB Phase 2b trial in December 2024.
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