Soligenix announced that the European Medicines Agency’s Committee for Orphan Medicinal Products issued a positive opinion on its request for orphan drug designation for SGX945, a dusquetide‑based therapy for Behçet’s disease. The decision follows the publication of Phase 2a data in December 2025 that demonstrated biological efficacy and safety in patients with the rare autoimmune disorder.
SGX945 has already earned orphan drug designation from the U.S. FDA on August 18 2025 and fast‑track status on January 8 2024. The EMA positive opinion will grant the company a 10‑year period of marketing exclusivity in the European Union once the drug is approved, providing a significant commercial advantage in a market that serves an estimated 50,000 patients across Europe.
The company’s CEO, Christopher J. Schaber, said, “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.” He added, “We are pleased to publish the data from our recent SGX945 Phase 2a trial in aphthous ulcers of Behçet’s disease, enabling the medical community to evaluate this novel mechanism and therapeutic.” The CEO also noted, “Given the role of the innate immune system, we believe that dusquetide may offer significant relief to patients.” and “The FDA’s decision to grant orphan drug designation to the SGX945 program 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.”
SGX945 is part of Soligenix’s innate defense regulator (IDR) platform, which the company positions as a versatile technology for treating a range of rare diseases. The EMA positive opinion strengthens the commercial prospects of SGX945 and reinforces Soligenix’s strategy to expand its IDR portfolio into new therapeutic areas.
With the EMA milestone, Soligenix is poised to pursue regulatory approval in the EU, potentially opening a new revenue stream for its rare‑disease pipeline and enhancing its overall market position.
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