Regenxbio said it will resubmit its Hunter syndrome gene therapy application after FDA personnel reversed an earlier position about needing a placebo-controlled component. The company said FDA acknowledged existing Navsunli clinical data is sufficient for considering accelerated approval, and that Regenxbio does not need to expand trials or initiate new studies. The U-turn follows earlier denials and appeals tied to requirements for more robust comparator evidence and concerns about endpoint and eligibility criteria. Regenxbio reported that the FDA recommended a Type A meeting to review longer-term biomarker and clinical data, expected in July. If accepted, the resubmission could speed regulatory review timelines for a rare neurodegenerative indication where treatment options remain limited and trial designs must often rely on external comparisons. The latest reversal also fits a broader pattern in which leadership changes at FDA have prompted reassessment of prior determinations for rare disease developers.