The FDA granted accelerated approval to Immedica Pharma’s Loargys (pegzilarginase) to treat arginase‑1 deficiency (ARG1‑D) in patients aged two and older, addressing a disorder that affects roughly 250 people in the U.S. Loargys replaces the deficient enzyme and aims to reduce plasma arginine levels, offering the first approved treatment option for hyperargininemia with neurologic manifestations. The decision follows Immedica’s acquisition of the enzyme program and provides a regulatory pathway for commercialization in a defined ultrarare population. The approval may prompt payer discussions around access and newborn/early‑diagnosis strategies given the progressive neurologic impact of untreated ARG1‑D.