Latus Bio reported FDA clearance of its investigational new drug (IND) application for LTS‑101, a gene therapy candidate targeting CNS manifestations of late‑infantile neuronal ceroid lipofuscinosis type 2 (CLN2). The agency also granted orphan drug, rare pediatric disease and fast‑track designations. Latus said the IND clearance enables initiation of first‑in‑human studies focused on pediatric CNS delivery and safety; investigators will monitor neurological outcomes tied to the underlying lysosomal storage disorder. The designations provide regulatory incentives intended to accelerate development and potential approval pathways for this rare pediatric condition. The clearance adds to momentum for gene therapies in pediatric neurodegenerative diseases and underscores the FDA’s continued pathway support for programs addressing rare, high‑unmet‑need disorders.