Soligenix Plunges 17.74% After FDA Orphan Drug Designation

On August 19, 2025, Soligenix's stock experienced a significant drop of 17.74% in pre-market trading, marking a notable shift in investor sentiment following recent developments.

Soligenix's recent surge in stock price was driven by the FDA's grant of orphan drug designation for dusquetide, the active component of SGX945, for the treatment of Behçet's Disease. This designation, based on promising results from Phase 2 clinical studies, offers market exclusivity, tax credits, and grants, which are significant incentives for the company's continued development in this area.

The FDA's decision to grant orphan drug designation to dusquetide has been a pivotal moment for Soligenix. This regulatory win not only validates the potential of dusquetide in treating Behçet's Disease but also provides the company with a competitive edge in the market. The designation is expected to accelerate the development and commercialization of dusquetide, potentially leading to new treatment options for patients suffering from this rare disease.