Sigma-Tau Pharmaceuticals, Inc., announced today that the U.S. Food and Drug Administration (FDA) has granted an orphan drug designation for the Company's investigational compound, STP-206 (lactobacillus acidophilus and Bifidobacterium animalis subsp. lactis), a live biotherapeutic being developed for the prevention of necrotizing enterocolitis (NEC) in premature infants with very low birth weight less than or equal to 1,500 grams. The Company is currently conducting a multi-center, double-blind, randomized, placebo-controlled Phase 1b/2a clinical trial for STP-206 at a number of different sites in the United States.