Soligenix, Inc. receives FDA orphan drug designation for dusquetide in treating Behçet's Disease.
The designation provides seven years of U.S. market exclusivity upon FDA approval.
Orphan drug designation offers financial and regulatory benefits to Soligenix.
Orphan Drug Designation
Dusquetide granted orphan drug status for Behçet's Disease treatment by the FDA.
Market Exclusivity
SGX945 to have 7 years of exclusive market rights in the U.S. post FDA approval.
Regulatory Benefits
Soligenix eligible for financial aids, FDA fee waivers,and tax credits with orphan drug status.
Unmet Medical Need
Behçet's Disease affects thousands globally, and dusquetide aims to address this with promising results.
- Dusquetide in SGX945 shows biological efficacy and safety in Behçet's Disease patients.
- Soligenix positioned to leverage financial benefits and advance the SGX945 program.
- FDA recognition boosts intellectual property portfolio for Soligenix's novel technology.
Soligenix's orphan drug designation for Behçet's Disease treatment marks a significant advancement, offering hope to patients with unmet medical needs. The recognition sets the stage for further progress in therapeutic development and underscores Soligenix's commitment to rare diseases.