Soligenix Inc. Receives FDA Orphan Drug Designation for SGX945 in the Treatment of Behçet's Disease, Securing Seven Years of Market Exclusivity
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.
Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Soligenix Inc. published the original content used to generate this news brief via PR Newswire (Ref. ID: PH52475) on August 18, 2025, and is solely responsible for the information contained therein.
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