Aurora Therapeutics, cofounded by leaders from the Baby KJ personalized-CRISPR effort and backed by Menlo Ventures, launched with seed funding to pursue grouped or 'umbrella' regulatory pathways for bespoke gene-editing therapies. The company intends to develop a suite of CRISPR-based treatments that can be adjusted to address multiple mutations within single rare-disease indications, starting with phenylketonuria (PKU). Aurora’s strategy leans on recent signals from regulators about more flexible frameworks for personalized therapies and emphasizes platform efficiencies in design and manufacturing. Company founders highlighted preclinical proof-of-concept and early regulatory engagement as reasons to pursue a grouped-variant development approach rather than separate dossiers for each mutation. Regulatory experts say Aurora’s model will test the FDA’s emerging 'plausible mechanism' path for individualized therapies; success could materially lower development costs for ultra-rare mutation classes but will require robust manufacturing controls and post-approval surveillance.