Prime Medicine reversed an earlier decision and will file for FDA approval of a prime‑editing gene therapy after treating two patients in a bespoke trial, marking the first regulatory push for a prime‑editing human treatment. The company said FDA rhetoric on rare disease pathways motivated the resubmission and that the therapy targets a defined mutation in chronic granulomatous disease (CGD). Regulators have signaled willingness to accelerate novel gene‑editing modalities but remain exacting on trial design and evidence standards. Prime’s filing will test how the agency balances expedited review for potentially curative, single‑site edits against limited patient experience and the need for broader safety and durability data.