The U.S. Food and Drug Administration granted accelerated approval to Immedica Pharma’s Loargys (pegzilarginase) to treat arginase 1 deficiency (ARG1‑D) in patients two years and older. The decision follows a prior regulatory setback and completes a reversal that brings an ultrarare enzyme replacement therapy to roughly 250 U.S. patients with the condition. Loargys degrades accumulated arginine via pegylated enzyme substitution; Immedica secured the asset through earlier corporate transactions and positioned the submission on accelerated approval grounds given the small patient population and unmet need. The approval will enable commercial access while the company collects confirmatory data per accelerated‑approval conditions. Clinicians and patient advocates framed the decision as a high‑impact change for a tiny, severely affected population; the approval also underscores the FDA’s willingness to revisit earlier decisions when new evidence or resubmissions address regulator concerns.