- “The EMA’s positive opinion signifies an important step for Soligenix as we continue to advance the program,” says company CEO.
- The designation provides incentives that may include protocol assistance, reduced regulatory fees and up to 10 years of market exclusivity following approval.
- Dusquetide is classified as an innate defense regulator, a type of compound designed to modulate the body’s innate immune system rather than suppress it outright.
For patients living with rare inflammatory diseases, regulatory milestones can mark the difference between stalled research and meaningful therapeutic progress. A positive opinion from the European Medicines Agency (EMA) not only validates a drug’s scientific rationale but can also unlock development incentives that accelerate its path forward. In that context, Soligenix (NASDAQ: SNGX), a late-stage biopharmaceutical company focused on developing treatments for rare diseases and areas of unmet medical need, announced that it has received a positive opinion from the EMA’s Committee for Orphan Medicinal Products for its pipeline product dusquetide in the treatment of Behcet’s disease.
“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,” said Soligenix CEO and president Christopher J. Schaber, PhD. Behçet’s disease is an area of unmet medical need, with…
NOTE TO INVESTORS: The latest news and updates relating to SNGX are available in the company’s newsroom at https://ibn.fm/SNGX
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