The FDA will reconsider Regenxbio’s Hunter syndrome gene therapy application after the agency reversed course on whether the company needed additional placebo-controlled enrollment. Regenxbio said FDA staff acknowledged its existing Navsunli clinical data is sufficient to support an accelerated approval pathway. The company plans to resubmit its biologics license application for RGX-121 in the third quarter. Regenxbio said the FDA also dropped the prior expectation that it add an appropriate untreated control, while urging a Type A meeting to review longer-term biomarker and clinical data. The decision follows a pattern of regulatory back-and-forth affecting rare-disease programs in recent months. For Regenxbio, the resubmission sets up a renewed path for approval in a disease where enzyme replacement cannot enter the brain.