Regenxbio said the FDA will reconsider its application for Navsunli (RGX-121), after the agency had rejected the company’s bid for accelerated approval for Hunter syndrome in February. Regenxbio characterized the agency’s latest move as aligning on the next steps after staff reversed their prior view that a placebo-controlled or additional comparator design would be required. The FDA acknowledged Regenxbio’s existing clinical data as sufficient to support a potential accelerated approval pathway, according to Regenxbio. The company said it would resubmit the application expected in the third quarter without enrolling additional patients or initiating new studies, following a Type A meeting to review longer-term biomarker and clinical data. The reversal sits within a broader period of FDA “U-turn” decisions impacting rare disease programs, after leadership changes and disputes over comparator use and eligibility criteria. Regenxbio previously faced criticism around external control comparability and the use of natural-history analyses and surrogate endpoints. The next milestone is the July meeting and the eventual resubmission review, which will determine whether the FDA’s latest position stabilizes or triggers further requests on trial design, endpoints, or labeling assumptions.