FDA Grants Soligenix Orphan Drug Designation for the Treatment of Behçet's Disease after Reviewing Recent Phase 2 Clinical Study Results

Provides SGX945 Seven Years of U.S. Market Exclusivity Upon FDA Approval 

PRINCETON, N.J., Aug. 18, 2025 /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that the Office of Orphan Products Development of the United States (U.S.) Food and Drug Administration (FDA) has granted orphan drug designation to dusquetide, the active ingredient in SGX945, for "treatment of Behçet's Disease" following review of recent Phase 2a clinical results demonstrating biological efficacy and safety in patients with Behçet's Disease.

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