Ultragenyx announces FDA approval of FAYUVI gene therapy
Ultragenyx said the FDA approved FAYUVI™ gene therapy for Sanfilippo syndrome type A (MPS IIIA).
Story updates
07:51:44 PM UTC
SquawkNews
Ultragenyx received full FDA approval for FAYUVI (UX111) to treat pediatric MPS IIIA and a Priority Review Voucher. Product is expected to ship to Qualified Treatment Centers in 30—60 days.Material DetailsContext by AI AnalystThis is a late-stage milestone converting a pipeline asset into a markete…
08:04:40 PM UTC
SquawkNews
Ultragenyx announced FDA full approval of FAYUVI for pediatric MPS IIIA, marking the company's second gene therapy approval.Key Highlights:Original SEC Filing: Ultragenyx Pharmaceutical Inc. [ RARE ] - 8-K - Sep. 17, 2026This is an AI-powered summary. It may contain inaccuracies. Consider verifying…
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