Ultragenyx wins FDA greenlight for first Sanfilippo therapy, priced at nearly $4M
RegulatoryapprovedFayuviPositive
AI Analysis
Summary
Ultragenyx received FDA approval for Fayuvi, its first Sanfilippo syndrome therapy, priced at nearly $4 million, following a previous rejection in 2025 due to manufacturing issues.
Outcome Details
FDA approval for Fayuvi, first Sanfilippo therapy. Previously rejected in 2025 due to manufacturing problems.
Importance:8/10
Sentiment:
0.85
FDA approvalgene therapyrare diseaseSanfilippo syndromepricing
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Published by BioSpace on September 18, 2026 12:32 PM