The FDA will reconsider approval for Regenxbio’s childhood gene therapy Navsunli (RGX-121) after the agency recently reversed key positions. Regenxbio said FDA staff acknowledged its existing clinical data are sufficient for an accelerated approval pathway and that the company would not need to enroll additional patients or conduct new studies. The latest pivot follows a Feb. rejection that cited uncertainties around eligibility criteria and the company’s reliance on external controls. Regenxbio said it will resubmit after discussions that included a requested Type A meeting to review longer-term biomarker and clinical data, with resubmission expected in the third quarter and an expedited FDA review. The announcement is the latest rare-disease regulatory back-and-forth in the wake of leadership changes at the FDA, where companies have argued that prior agreements on data and comparator approaches shifted.