A wave of ventures pursuing heritable genome editing emerged, with one U.S. entrepreneur raising significant early funding to study the ethics and feasibility of gene-edited embryos. At the same time, the teams behind the bespoke CRISPR therapy for 'Baby KJ' published interactions with the FDA and outlined a pathway for bespoke gene therapies aimed at ultra‑rare patients. The new startups position themselves as research-first entities to investigate safety, governance, and technology for heritable edits—an area that remains illegal in many jurisdictions and ethically contested. The Baby KJ team’s disclosures give academics and small biotechs a practical dossier for navigating FDA interactions for individualized gene-editing therapies. These twin developments highlight mounting commercial and clinical interest in using genome editing for rare and heritable conditions, and they underscore regulatory, ethical, and reimbursement obstacles that will define whether such approaches progress beyond research programs.