The FDA granted accelerated approval to Denali Therapeutics’ Hunter syndrome drug Avlayah (tividenofusp alfa), according to STAT+. The approval follows a period of tougher rare disease scrutiny and comes after earlier denials and delays that had heightened uncertainty for patients and investors. Avlayah is a brain-penetrating biologic leveraging Denali’s proprietary drug-delivery technology designed to cross the blood-brain barrier. The clearance is notable because it adds another rare disease precedent to a developing FDA posture on what evidence is required for acceleration. Industry stakeholders will watch how the surrogate-endpoint approach and confirmatory commitments shape post-approval studies, given the agency’s recent emphasis on higher standards of evidence for rare disease biologics. The approval also provides Denali with a pathway to regain traction after regulatory pressure and strengthens the company’s position in neuro-lysosomal disorders.