Recent advancements mark critical progress in gene and cell therapy. Kriya Therapeutics raised $313 million to fuel development of a diverse pipeline including neurology and ophthalmology programs. Opus Genetics secured FDA IND clearance for a gene therapy targeting bestrophin-1 inherited retinal disease. Notably, gene therapy candidate QT-019B from Qihan Biotech received US IND authorization targeting systemic lupus erythematosus. Meanwhile, regulatory updates see delays such as FDA’s extended review of Regenxbio’s Hunter syndrome gene therapy, underscoring the dynamic regulatory environment confronting novel modalities.