On August 14, 2025, Soligenix, Inc. (SNGX) announced financial results for the second quarter of 2025 and provided a business update. Following the release of promising Phase 2a clinical trial results for SGX945 (dusquetide) in Behcet's Disease, the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) to dusquetide for "treatment of Behcet's Disease". The company has begun work on a subcutaneous formulation of SGX945, after which it is planning to perform a Phase 2b trial in Behcet's Disease. Before the end of 2025, we anticipate topline results from the Phase 2a clinical trial of SGX302 (synthetic hypericin) in patients with mild-to-moderate psoriasis along with continued clinical updates from the ongoing investigator-initiated study (IIS) evaluating HyBryte treatment for up to 54 weeks in patients with cutaneous T cell lymphoma (CTCL).

20 Aug 2025
SNGX: Dusquetide (SGX945) Granted Orphan Drug Designation for Behcet's Disease

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SNGX: Dusquetide (SGX945) Granted Orphan Drug Designation for Behcet's Disease
- Published:
20 Aug 2025 -
Author:
David Bautz -
Pages:
6 -
On August 14, 2025, Soligenix, Inc. (SNGX) announced financial results for the second quarter of 2025 and provided a business update. Following the release of promising Phase 2a clinical trial results for SGX945 (dusquetide) in Behcet's Disease, the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) to dusquetide for "treatment of Behcet's Disease". The company has begun work on a subcutaneous formulation of SGX945, after which it is planning to perform a Phase 2b trial in Behcet's Disease. Before the end of 2025, we anticipate topline results from the Phase 2a clinical trial of SGX302 (synthetic hypericin) in patients with mild-to-moderate psoriasis along with continued clinical updates from the ongoing investigator-initiated study (IIS) evaluating HyBryte treatment for up to 54 weeks in patients with cutaneous T cell lymphoma (CTCL).