Soligenix (SNGX) announced that the European Medicines Agency Committee for Orphan Medicinal Products provided a positive recommendation on the company’s request for orphan drug designation for dusquetide for the treatment of Behcet’s Disease, following review of the recently published Phase 2a clinical results demonstrating biological efficacy and safety in patients with Behcet’s Disease. The next step in the process will be ratification of the positive opinion by the European Commission. SGX945 has previously been granted both orphan drug and fast track designations from the US FDA for the treatment of Behcet’s Disease.
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