Yeji
NDA/BLA filedconf 0.95

dordaviprone — NDA/BLA filed

$JAZZ · Jazz Pharmaceuticals plc · recurrent H3 K27M-mutant diffuse glioma (accelerated approval)
Event date
Date TBD
Sponsor runway
cash-flow +
$1.84B liquid

Evidence

A New Drug Application (NDA) for accelerated approval of dordaviprone in recurrent H3 K27M-mutant diffuse glioma was recently accepted and granted Priority Review by FDA.
Source: Press release · 2025-03-05View press release ↗

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

2 insiders · 0 buys · 5 sells
Sell10b5-1
2026-05-01
COZADD BRUCE C
Director
6,000 @ $203.33$1.22M
Sell10b5-1
2026-04-01
COZADD BRUCE C
Director
3,684 @ $190.22$701K
Sell10b5-1
2026-04-01
COZADD BRUCE C
Director
2,292 @ $190.94$438K
Sell10b5-1
2026-04-01
COZADD BRUCE C
Director
24 @ $191.74$5K
Sell
2026-03-09
Carr Patricia
SVP, Chief Accounting Officer
1,287 @ $182.94$235K