Tuesday, 02 January 2024 12:17 GMT

Biomednewsbreaks - Soligenix Inc. (NASDAQ: SNGX) Receives EU Orphan Drug Designation For Dusquetide In Behçet Disease


(MENAFN- Investor Brand Network) Soligenix (NASDAQ: SNGX) announced the European Commission has granted orphan drug designation to dusquetide (SGX945) for the treatment of Behçet Disease, following a positive recommendation from the European Medicines Agency and supportive Phase 2a data demonstrating biological efficacy and safety. The designation provides up to 10 years of market exclusivity in the European Union and adds to existing FDA orphan and fast track designations, as the company advances its innate defense regulator platform targeting unmet needs in rare autoimmune conditions.

To view the full press release, visit

About Soligenix

Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Our Specialized BioTherapeutics business segment is developing and moving toward potential commercialization of HyBryte(TM) (SGX301 or synthetic hypericin sodium) as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma (CTCL). With successful completion of the second Phase 3 study, regulatory approvals will be sought to support potential commercialization worldwide. Development programs in this business segment also include expansion of synthetic hypericin (SGX302) into psoriasis, our first-in-class innate defense regulator (IDR) technology, dusquetide (SGX942) for the treatment of inflammatory diseases, including oral mucositis in head and neck cancer, and (SGX945) in Behcet's Disease.

Our Public Health Solutions business segment includes development programs for RiVax(R), our ricin toxin vaccine candidate, as well as our vaccine programs targeting filoviruses (such as Marburg and Ebola) and CiVax(TM), our vaccine candidate for the prevention of COVID-19 (caused by SARS-CoV-2). The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax(R). To date, this business segment has been supported with government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID), the Defense Threat Reduction Agency (DTRA) and the Biomedical Advanced Research and Development Authority (BARDA).

NOTE TO INVESTORS: The latest news and updates relating to SNGX are available in the company's newsroom at

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