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KaloBios' cystic fibrosis candidate granted Orpahn Drug designation by FDA

KaloBios announced that the FDA has granted the company orphan drug designation for KB001-A, an anti-PcrV monoclonal antibody fragment, for the treatment of cystic fibrosis patients with Pseudomonas aeruginosa. KaloBios is currently enrolling patients in a Phase 2 multiple-dose, randomized, double-blind, placebo-controlled clinical trial with KB001-A in CF patients chronically infected with Pa. The primary endpoint is time-to-need for antibiotics.