Health
FDA Grants Soligenix Orphan Drug Designation for the Treatment of Behçet's Disease after Reviewing Recent Phase 2 Clinical Study Results
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
About this update from Soligenix, Inc.
[{"type":"text","content":"Provides SGX945 Seven Years of U.S. Market Exclusivity Upon FDA Approval ","length":72,"tagName":"p","attribs":{}},{"type":"text","content":"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.","length":658,"tagName":"p"},{"type":"image","alt":"(PRNewsfoto/Soligenix, Inc.)","displaySize":"","headline":null,"caption":"(PRNewsfoto/Soligenix, Inc.)","className":"","disableSlideshowImg":false,"size":{"original":{"width":400,"height":112,"url":"https://media.zenfs.com/en/prnewswire.com/85ba4191e64f574a13cd0c133f4a3048"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/0bSTAeYRTNnLNEjUJiiRHg--/YXBwaWQ9aGlnaGxhbmRlcjt3PTcwNTtoPTE5NztjZj13ZWJw/https://media.zenfs.com/en/prnewswire.com/85ba4191e64f574a13cd0c133f4a3048","width":400,"height":112}},"href":"https://mma.prnewswire.com/media/1768046/Soligenix_Logo.html","hrefExternal":true,"rel":"nofollow"},{"type":"text","content":"The U.S. Orphan Drug Act is intended to assist and encourage companies to develop safe and effective therapies for the treatment of rare diseases and disorders, defined as one that affects fewer than 200,000 people in the U.S. 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 wide 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 (NDA), and certain tax credits.","length":626,"tagName":"p"},{"type":"text","content":""Behçet's Disease is an area of unmet medical need, with up to 18,000 people in the U.S., 50,000 in Europe, 350,000 people in Turkey and as many as 1 million people worldwide affecte...