$SNGX: Soligenix Receives Positive Opinion from the European Medicines Agency on the Request for Orphan Drug Designation for SGX945 for the Treatment of Behçet’s Disease

PRINCETON, NJ – February 26, 2026 – Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) provided a positive recommendation on the Company’s request for orphan drug designation for dusquetide (the active pharmaceutical ingredient in SGX945) for the treatment of Behçet's Disease, following review of the recently published Phase 2a clinical results demonstrating biological efficacy and safety in patients with Behçet'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 Food and Drug Administration (FDA) for the treatment of Behçet's Disease.

Orphan drug designation by the EMA provides a 10-year period of marketing exclusivity in the European Union (EU) after product approval. Orphan designation also provides incentives for companies seeking protocol assistance from the EMA during the product development phase, and direct access to the centralized authorization procedure. The European Commission grants orphan designations for medicines that treat a life-threatening or chronically debilitating condition affecting no more than five in 10,000 persons in the EU and where no satisfactory treatment is available.

“We are extremely pleased to have received the positive opinion from the COMP and look forward to the European Commission granting the orphan drug designation for the SGX945 program,” stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. “Behçet’s Disease is an area of unmet medical need, with up to 18,000 people in the U.S., 50,000 people in Europe, 350,000 people in Turkey and as many as 1 million people worldwide affected by this incurable disease. Given the clinically meaningful improvements seen in our Phase 2 proof-of-concept study in patients with oral aphthous ulcers due to Behçet’s Disease, we are hopeful dusquetide will have a role to play in helping underserved patients suffering from this difficult to treat and chronic auto-immune disease. The EMA’s positive opinion 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.”

FULL RELEASE: https://ir.soligenix.com/2026-02-26-Soligenix-Receives-Positive-Opinion-from-the-European-Medicines-Agency-on-the-Request-for-Orphan-Drug-Designation-for-SGX945-for-the-Treatment-of-Behcets-Disease