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EU grants orphan drug status to Soligenix's SGX945 for Behçet's Disease after positive Phase 2a results

Market News
26 Mar 2026
PRNewsWire
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Bullish
pluang ai news

Soligenix's drug SGX945, containing dusquetide, received orphan drug designation from the European Commission for treating Behçet's Disease, following positive Phase 2a clinical trial results showing safety and efficacy. This designation grants 10 years of market exclusivity in the EU and access to regulatory incentives. Behçet's Disease is a rare, chronic autoimmune disorder with limited treatment options, affecting up to 1 million people worldwide. SGX945 has also received orphan and fast track status from the FDA in the U.S., and Soligenix plans to continue advancing the drug's development to address this unmet medical need.

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