PDUFAconf 0.99
dordaviprone — PDUFA
$JAZZ · Jazz Pharmaceuticals plc · recurrent H3 K27M-mutant diffuse glioma (accelerated approval)
Event date
August 18, 2025
292 days ago
Sponsor runway
cash-flow +
$1.84B liquid
Evidence
Comparable historical pdufas· last 5 years · same event type
75% hit rate (3/4)
| Ticker | Drug | Date | Outcome |
|---|---|---|---|
| $RCKT | kresladi | 2026-03-28 | success |
| $RYTM | imcivree | 2026-03-20 | success |
| $CYTK | aficamten | 2025-12-26 | unknown |
| $ALDX | reproxalap | 2025-12-16 | unknown |
| $BCRX | orladeyo | 2025-12-12 | success |
| $OMER | narsoplimab | 2025-09-25 | unknown |
| $BCRX | orladeyo (berotralstat) | 2025-09-12 | unknown |
| $ETON | et-400 | 2025-05-28 | unknown |
| $ALDX | reproxalap | 2025-04-02 | failure |
| $IONS | olezarsen | 2024-12-19 | unknown |
Recent insider activity· ±90 days
14 insiders · 0 buys · 7 sells
Sell10b5-1
2025-10-03COZADD BRUCE C
Director
3,500 @ $140.00$490K
Sell10b5-1
2025-10-01COZADD BRUCE C
Director
2,000 @ $131.78$264K
Tax
2025-09-14COZADD BRUCE C
Director
15,647 @ $126.16$1.97M
Sell10b5-1
2025-09-02COZADD BRUCE C
Director
3,000 @ $127.23$382K
Other
2025-08-18ENRIGHT PATRICK G
Director
5,000 @ ——
Tax
2025-08-08ENRIGHT PATRICK G
Director
1,805 @ $111.25$201K
Tax
2025-08-08Hamill Laura
Director
1,805 @ $111.25$201K
Tax
2025-08-08Cook Jennifer E.
Director
1,805 @ $111.25$201K
Tax
2025-08-08Kennedy Patrick
Director
1,959 @ $111.25$218K
Tax
2025-08-08Smith Mark Douglas
Director
1,805 @ $111.25$201K
Tax
2025-08-08RIEDEL NORBERT G
Director
1,805 @ $111.25$201K
Tax
2025-08-08McSharry Heather Ann
Director
1,959 @ $111.25$218K
Tax
2025-08-08ORiordan Anne
Director
1,805 @ $111.25$201K
Tax
2025-08-08Winningham Rick E
Director
1,805 @ $111.25$201K
Tax
2025-08-08O'Keefe Kenneth W
Director
1,805 @ $111.25$201K
Grant
2025-08-07Cook Jennifer E.
Director
3,507 @ ——
Grant
2025-08-07McSharry Heather Ann
Director
3,507 @ ——
Grant
2025-08-07GALA RENEE D
President & CEO
18,808 @ ——
Grant
2025-08-07ENRIGHT PATRICK G
Director
3,507 @ ——
Grant
2025-08-07Mulligan Seamus
Director
3,507 @ ——
Grant
2025-08-07Kennedy Patrick
Director
3,507 @ ——
Grant
2025-08-07Winningham Rick E
Director
3,507 @ ——
Grant
2025-08-07RIEDEL NORBERT G
Director
3,507 @ ——
Grant
2025-08-07Smith Mark Douglas
Director
3,507 @ ——
Grant
2025-08-07ORiordan Anne
Director
3,507 @ ——
Grant
2025-08-07O'Keefe Kenneth W
Director
3,507 @ ——
Grant
2025-08-07Hamill Laura
Director
3,507 @ ——
Tax
2025-08-05Pearce Samantha
EVP, Chief Commercial Officer
577 @ $116.10$67K
Sell10b5-1
2025-08-01COZADD BRUCE C
Director
1,000 @ $113.21$113K
Sell10b5-1
2025-07-01COZADD BRUCE C
Director
500 @ $105.26$53K
Sell10b5-1
2025-06-03COZADD BRUCE C
Director
500 @ $110.00$55K
Sell10b5-1
2025-06-02COZADD BRUCE C
Director
500 @ $107.90$54K