The US FDA has granted “orphan” status on BX004 from Israel’s BiomX (see here previously) for the treatment of chronic lung infections suffered by cystic fibrosis patients. Orphan designation is given for rare conditions that have no current treatment.

https://ir.biomx.com/news-events/press-releases/detail/101/biomx-receives-orphan-drug-designation-from-the-u-s-food