Yeji
PDUFAconf 0.99

ux111 — PDUFA

$RARE · Ultragenyx Pharmaceutical Inc. · Sanfilippo syndrome Type A (MPS IIIA)
Event date
September 19, 2026
in 105 days
Sponsor runway
3 mo
$175.0M liquid

Evidence

The FDA set a Prescription Drug User Fee Act (PDUFA) action date of September 19, 2026.
Source: 8-K filed 2026-04-02View on EDGAR ↗0001193125-26-139084

Comparable historical pdufas· last 5 years · same event type

75% hit rate (3/4)
TickerDrugDateOutcome
$RCKTkresladi2026-03-28success
$RYTMimcivree2026-03-20success
$CYTKaficamten2025-12-26unknown
$ALDXreproxalap2025-12-16unknown
$BCRXorladeyo2025-12-12success
$OMERnarsoplimab2025-09-25unknown
$BCRXorladeyo (berotralstat)2025-09-12unknown
$ETONet-4002025-05-28unknown
$ALDXreproxalap2025-04-02failure
$IONSolezarsen2024-12-19unknown

Recent insider activity· ±90 days

No insider Form 4 activity reported on $RARE in the 90 days around this event.