Why Is Soligenix Stock Soaring On Monday?

Core Viewpoint - Soligenix, Inc. has seen a significant increase in stock price following the U.S. FDA granting orphan drug designation to dusquetide for Behçet's Disease, supported by recent positive clinical trial results demonstrating efficacy and safety [1][6]. Company Summary - The orphan drug designation provides Soligenix with a seven-year market exclusivity upon final FDA approval, along with various financial and regulatory benefits such as government grants for clinical trials, waiver of FDA user fees for New Drug Application submission, and certain tax credits [3]. - Dusquetide has shown safety and tolerability in a Phase 1 study involving 84 healthy volunteers, and positive efficacy results in Phase 2 and 3 studies with over 350 subjects suffering from oral mucositis due to chemoradiation therapy for head and neck cancer [6]. - The stock price of Soligenix has increased by 67.29%, reaching $4.65 at the time of publication [7]. Industry Summary - Behçet's Disease is a rare inflammatory disorder affecting up to 18,000 people in the U.S., 50,000 in Europe, 350,000 in Turkey, and potentially one million people worldwide, characterized by painful sores and eye inflammation [4]. - The U.S. Orphan Drug Act aims to encourage the development of therapies for rare diseases, providing incentives for companies like Soligenix to invest in these areas [2].