The FDA granted IND clearance to Latus Bio for LTS-101, a gene therapy candidate for the CNS manifestations of late-infantile neuronal ceroid lipofuscinosis type 2 (CLN2), and also awarded orphan drug, rare pediatric disease and fast-track designations. Latus said the clearance allows the company to start clinical evaluation focused on CNS delivery and neurodegenerative endpoints. In parallel, Vectory Therapeutics received IND clearance for VTX-002, a vectorized antibody designed to target TDP-43 pathology in amyotrophic lateral sclerosis (ALS), enabling the PIONEER-ALS Phase I/II trial. Both clearances reflect ongoing industry momentum to move novel genetic and biologic approaches into early human testing for rare and neurodegenerative diseases. These regulatory greenlights mark near-term clinical starts that will test distinct modalities — AAV/gene therapy for lysosomal storage disease and vectorized antibodies for proteinopathy-driven ALS — and underscore the FDA’s openness to expedited pathways where unmet need is high.