Soligenix’s dusquetide granted Orphan Drug Designation in Behcet’s Disease

Soligenix (SNGX) announced that the Office of Orphan Products Development of the FDA has granted orphan drug designation to dusquetide, the active ingredient in SGX945, for “treatment of Behcet’s Disease” following review of recent Phase 2a clinical results demonstrating biological efficacy and safety in patients with Behcet’s Disease. In addition to providing a seven-year term of market exclusivity upon final FDA approval, orphan drug designation also positions Soligenix to be able to leverage a range of financial and regulatory benefits, including government grants for conducting clinical trials, waiver of expensive FDA user fees for the potential submission of a New Drug Application, and certain tax credits.