Regenxbio said it will resubmit its Hunter syndrome gene therapy after what it described as another shift in FDA position following leadership departures. The biotech’s plan follows an earlier FDA rejection tied to its mucopolysaccharidosis type II (MPS II) program. Regenxbio’s therapy targets the neurological form of MPS II, where enzyme replacement therapies are limited by their inability to enter the brain. By resubmitting with the existing data package, Regenxbio is trying to restart its regulatory process without conducting a new study. The company’s decision adds to a broader pattern of abrupt FDA course changes in gene therapy approvals and reconsiderations over recent months, as multiple developers navigate changing expectations for submissions.