Soligenix (NASDAQ:SNGX) stock skyrocketed 88% after the FDA awarded orphan drug designation to dusquetide, the active component of SGX945, for the treatment of Behçet’s Disease.
The designation follows the FDA’s evaluation of recent Phase 2a clinical trials, which demonstrated both biological efficacy and safety in patients with this rare autoimmune disorder. Orphan drug status provides Soligenix with seven years of market exclusivity upon final FDA approval, as well as potential financial incentives, including government grants for clinical studies, waiver of FDA user fees for a potential New Drug Application, and eligibility for certain tax credits.
Behçet’s Disease affects roughly 18,000 individuals in the U.S., 50,000 in Europe, 350,000 in Turkey, and up to 1 million worldwide. The condition is marked by oral aphthous ulcers and is widely recognized as difficult to treat and incurable.
Christopher J. Schaber, President and CEO of Soligenix, commented: “The FDA’s decision to grant orphan drug designation to the SGX945 program signifies an important step for Soligenix as we continue to advance the program and adds significantly to the existing intellectual property estate surrounding this novel technology.”
Soligenix is a late-stage biopharmaceutical company dedicated to developing and commercializing treatments for rare diseases with unmet medical needs. The orphan drug designation aims to incentivize the creation of therapies for conditions affecting fewer than 200,000 people in the United States.
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