Soligenix's 78.42% Surge on FDA Orphan Drug Designation Drives $890M Trading Volume Ranks 87th in Market Activity

Soligenix (NASDAQ:SNGX) surged 78.42% on August 18, 2025, with a trading volume of $0.89 billion, ranking 87th in market activity. The rally followed the U.S. Food and Drug Administration’s (FDA) grant of orphan drug designation to dusquetide, the active ingredient in SGX945, for the treatment of Behçet’s Disease. This regulatory milestone provides the company with seven years of market exclusivity upon FDA approval, along with potential financial incentives such as tax credits and reduced regulatory fees.

The designation follows positive Phase 2a clinical results demonstrating dusquetide’s safety and efficacy in Behçet’s Disease patients. The drug, an innate defense regulator (IDR), modulates immune responses to promote tissue healing and reduce inflammation. It has shown promising outcomes in prior trials for oral mucositis and has a strong intellectual property position. The FDA’s decision underscores the unmet medical need in Behçet’s Disease, a chronic autoimmune condition affecting approximately 18,000 individuals in the U.S. and 1 million globally, with limited treatment options.

Christopher J. Schaber, Soligenix’s CEO, emphasized the significance of the designation in advancing the SGX945 program and strengthening its intellectual property portfolio. The company’s pipeline also includes dusquetide-based therapies for oral mucositis and other rare diseases. The orphan drug designation aligns with Soligenix’s focus on developing treatments for underserved patient populations, leveraging regulatory incentives to de-risk development costs and accelerate commercialization pathways.

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