PRINCETON, N.J., Aug. 18, 2025/PRNewswire/ -- Soligenix, Inc., a late-stage biopharmaceutical company, has announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to dusquetide, the active ingredient in SGX945, for the treatment of Behçet's Disease. This designation follows promising results from recent Phase 2a clinical trials demonstrating the drug's biological efficacy and safety. With this designation, Soligenix will benefit from seven years of market exclusivity upon FDA approval, as well as financial and regulatory incentives including government grants, waived FDA user fees, and tax credits. This development marks a significant advancement for Soligenix in addressing the unmet medical needs associated with Behçet's Disease, which affects a small population in the U.S. but remains a challenging autoimmune disorder globally.
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