Latus Bio announced FDA IND clearance for LTS‑101, its gene therapy candidate targeting the CNS manifestations of late‑infantile neuronal ceroid lipofuscinosis type 2 (CLN2). The agency also granted orphan drug, rare pediatric disease, and fast track designations to LTS‑101. Latus said the IND enables its planned first‑in‑human study and positions the program for expedited development pathways given the high unmet medical need. The designations aim to accelerate development timelines and regulatory interactions for this ultra‑rare pediatric disorder.