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Investing.com -- Soligenix (NASDAQ:SNGX) stock surged 88% after the FDA granted orphan drug designation to dusquetide, the active ingredient in SGX945, for the treatment of Behçet’s Disease.
The designation follows the FDA’s review of recent Phase 2a clinical results that demonstrated biological efficacy and safety in patients with the rare autoimmune condition. Orphan drug status provides Soligenix with seven years of market exclusivity upon final FDA approval, along with potential financial benefits including government grants for clinical trials, waiver of FDA user fees for a potential New Drug Application, and certain tax credits.
Behçet’s Disease affects up to 18,000 people in the U.S., 50,000 in Europe, 350,000 in Turkey, and as many as 1 million people worldwide. The condition is characterized by oral aphthous ulcers and is considered difficult to treat and incurable.
"The FDA’s decision to grant orphan drug designation to the SGX945 program signifies an important step for Soligenix as we continue to advance the program and adds significantly to the existing intellectual property estate surrounding this novel technology," said Christopher J. Schaber, President and CEO of Soligenix.
Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases with unmet medical needs. The orphan drug designation is designed to encourage companies to develop therapies for conditions affecting fewer than 200,000 people in the United States.
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