Curated News
By: NewsRamp Editorial Staff
February 26, 2026
Soligenix's SGX945 Gains EU Orphan Drug Recommendation for Behçet Disease
TLDR
- Soligenix gains potential 10-year EU market exclusivity for SGX945 in Behçet Disease, offering a competitive edge in rare disease treatment.
- The EMA committee recommended orphan designation for dusquetide in SGX945 based on Phase 2a data showing biological efficacy and safety for Behçet Disease.
- This orphan designation advances treatment for Behçet Disease patients, addressing an unmet medical need and improving quality of life for those affected.
- Soligenix's dusquetide technology demonstrates biological efficacy in Phase 2a trials, now progressing toward EU orphan drug status for Behçet Disease.
Impact - Why it Matters
This news matters because it represents a critical step toward providing new treatment options for patients with Behçet Disease, a rare and chronic inflammatory disorder that currently lacks a cure and often leads to severe complications like vision loss and organ damage. The orphan drug designation in the EU, if ratified, could accelerate SGX945's development and approval, offering hope for improved therapies and potentially better quality of life for affected individuals. For investors and the biotech industry, it highlights Soligenix's progress in leveraging its innate defense regulator technology to address unmet medical needs, potentially enhancing the company's market position and valuation. On a broader scale, advancements in rare disease treatments like this underscore the importance of regulatory incentives in fostering innovation and addressing healthcare gaps, benefiting patients, healthcare systems, and society by reducing long-term costs and improving outcomes.
Summary
Soligenix Inc. (NASDAQ: SNGX), a late-stage biopharmaceutical company, has achieved a significant regulatory milestone with the European Medicines Agency Committee for Orphan Medicinal Products issuing a positive recommendation for orphan drug designation of dusquetide, the active ingredient in its drug candidate SGX945, for the treatment of Behçet Disease. This recommendation follows the review of recently published Phase 2a data demonstrating biological efficacy and safety, and it now advances to the European Commission for ratification. The company highlighted that orphan designation in the European Union provides 10 years of market exclusivity upon approval, along with development incentives and centralized authorization access, building on previous orphan drug and fast track designations from the U.S. Food and Drug Administration for the same condition. This development is part of Soligenix's broader strategy to address rare diseases with unmet medical needs through its Specialized BioTherapeutics business segment.
The company's pipeline extends beyond SGX945, including HyBryte™ (SGX301) for cutaneous T-cell lymphoma, which has completed a second Phase 3 study and is moving toward potential worldwide commercialization, as well as SGX942 for inflammatory diseases like oral mucositis. Additionally, Soligenix's Public Health Solutions business segment focuses on vaccine candidates such as RiVax® for ricin toxin, filovirus vaccines, and CiVax™ for COVID-19, supported by government funding from agencies like the National Institute of Allergy and Infectious Diseases and the Biomedical Advanced Research and Development Authority. The news release was distributed by BioMedWire, a specialized communications platform within the Dynamic Brand Portfolio of IBN, which provides enhanced press release services and broad syndication to reach investors and the public effectively. For more details, readers can view the full press release or access the company's newsroom for updates on SNGX.
Source Statement
This curated news summary relied on content disributed by InvestorBrandNetwork (IBN). Read the original source here, Soligenix's SGX945 Gains EU Orphan Drug Recommendation for Behçet Disease
