Shares of two small-cap biopharmaceutical companies jumped in pre-market trading after favorable regulatory developments from the U.S. Food and Drug Administration on Monday. Soligenix rose as much as 44% after the agency’s Office of Orphan Products Development granted orphan drug designation to dusquetide, the active ingredient in SGX945, for the treatment of Behçet’s disease. The status confers up to seven years of U.S. market exclusivity if the therapy wins approval, along with tax credits and fee waivers. Behçet’s disease affects an estimated 18,000 people in the United States, and Soligenix said recent Phase 2 data showed biological efficacy and safety in patients with the disorder. BioXcel Therapeutics advanced about 27% after receiving positive feedback from an FDA pre-supplemental New Drug Application meeting for BXCL501, a sublingual film formulation of dexmedetomidine being developed to manage agitation in adults with bipolar disorder or schizophrenia. The company said the comments support its plan to submit the sNDA, a key step toward potentially expanding the drug’s label.