FAYUVI is a Ultragenyx Pharmaceutical Inc. program in Sanfilippo syndrome type A (MPS IIIA). The FDA approved it on Sep 17, 2026. 1 FDA decision on record below. Every date links its source.
All upcoming FDA decision dates on the 2026 PDUFA calendar
Indication under review: Sanfilippo syndrome type A (MPS IIIA). Sponsor: Ultragenyx Pharmaceutical Inc. (RARE). Review status: Standard full approval on September 17, 2026, two days before the September 19 PDUFA goal date; the first FDA-approved treatment for Sanfilippo syndrome type A and Ultragenyx's second gene therapy approval. A Priority Review Voucher was awarded. UX111 (ABO-102) was licensed from Abeona Therapeutics (ABEO). Market-cap tier at the time we tracked it: Small. We track 2 catalyst events for this program: 0 upcoming and 2 in the record. A PDUFA date is the FDA's target date to complete review of a marketing application; a readout is the sponsor's expected date for clinical trial results. What a PDUFA date is · why we do not compare trial results across drugs.
No upcoming catalyst is on our calendar for FAYUVI; 1 FDA decision is on record below.
On Sep 17, 2026 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.
In our records FAYUVI is under review or in development for Sanfilippo syndrome type A (MPS IIIA).
Ultragenyx Pharmaceutical Inc. (RARE).
Yes. The FDA approved an application for FAYUVI on Sep 17, 2026; the decision page linked above carries the source.
FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.