A wave of startups is positioning to exploit emerging FDA frameworks for bespoke, personalized gene‑editing therapies. One new CRISPR company is explicitly betting that regulators will ease pathways for 'personalized' edits, aiming to avoid repetitive full trials for minor, patient‑specific adjustments. Aurora Therapeutics—backed by CRISPR pioneers and investors—plans to pursue FDA 'plausible mechanism' routes to scale treatments for multiple rare mutations under a single regulatory umbrella. The strategy reflects industry pressure to adapt approval models for ultra‑rare and patient‑specific genomic medicines.