On August 23, 2024, META Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its investigational new drug META-001-PH for the treatment of Primary Hyperoxaluria (PH). This marks META Pharmaceuticals’ second designation following the Rare Pediatric Disease Designation (RPDD) received on August 5, 2024, meaning META-001-PH has now achieved dual ODD/RPDD designation. Primary Hyperoxaluria is a rare genetic disorder that can lead to kidney stones and renal failure, and may be life-threatening in severe cases. ODD is a designation granted by the FDA to drugs or biologics intended for the prevention, diagnosis, or treatment of rare diseases or conditions affecting fewer than 200,000 people in the United States. This designation is awarded under Section 526 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360bb).