Yeji
NDA/BLA filedconf 0.75

ux111 — NDA/BLA filed

$RARE · Ultragenyx Pharmaceutical Inc. · Sanfilippo syndrome Type A (MPS IIIA)
Event date
Date TBD
Sponsor runway
3 mo
$175.0M liquid

Evidence

These longer-term data were included in the resubmitted Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking accelerated approval for UX111.
Source: 8-K filed 2026-02-03View on EDGAR ↗0001193125-26-034474

Comparable historical nda/bla fileds· last 5 years · same event type

TickerDrugDateOutcome
$AXSM2025-12-31unknown
$RCKTkresladi2025-10-14unknown
$ALDXreproxalap2025-07-17unknown
$ETONet-6002025-07-08unknown
$BCRXorladeyo (berotralstat)2025-05-14unknown
$CORTrelacorilant2025-03-03unknown
$ALDXreproxalap2024-11-01unknown
$AXSMaxs-072024-09-04unknown
$RCKTkresladi2023-10-02unknown
$GERNimetelstat2023-08-21unknown

Recent insider activity· ±90 days

9 insiders · 0 buys · 3 sells
Sell10b5-1
2026-05-18
SULIMAN SHEHNAAZ
Director
5,740 @ $25.12$144K
Grant
2026-05-14
Dunsire Deborah
Director
14,058 @
Grant
2026-05-14
Sanders Corazon (Corsee) D.
Director
7,751 @
Grant
2026-05-14
Sanders Corazon (Corsee) D.
Director
14,058 @
Grant
2026-05-14
NARACHI MICHAEL
Director
7,751 @
Grant
2026-05-14
NARACHI MICHAEL
Director
14,058 @
Grant
2026-05-14
Ray Amrit
Director
7,751 @
Grant
2026-05-14
Ray Amrit
Director
14,058 @
Grant
2026-05-14
Fust Matthew K
Director
7,751 @
Grant
2026-05-14
Fust Matthew K
Director
14,058 @
Grant
2026-05-14
Dunsire Deborah
Director
7,751 @
Grant
2026-05-14
WELCH DANIEL G
Director
7,751 @
Grant
2026-05-14
WELCH DANIEL G
Director
14,058 @
Grant10b5-1
2026-05-14
SULIMAN SHEHNAAZ
Director
7,751 @
Grant10b5-1
2026-05-14
SULIMAN SHEHNAAZ
Director
14,058 @
Sell
2026-05-05
Crombez Eric
EVP and Chief Medical Officer
344 @ $24.96$9K
Sell10b5-1
2026-05-01
Horn Howard
Chief Financial Officer
4,683 @ $24.90$117K