Yeji
FDA approvaloutcome: successconf 1.00

zepzelca — FDA approval

$JAZZ · Jazz Pharmaceuticals plc
Event date
October 2, 2025
247 days ago
Sponsor runway
cash-flow +
$1.84B liquid

Evidence

“openFDA SUPPL (EFFICACY) approval of ZEPZELCA — application NDA213702”
Source ↗

Comparable historical fda approvals· last 5 years · same event type

100% hit rate (10/10)
TickerDrugDateOutcome
$INCYzynyz2026-05-18success
$INCYjakafi xr2026-05-01success
$AXSMauvelity2026-04-30success
$INCYzynyz2026-03-30success
$BIIBspinraza2026-03-27success
$CORTlifyorli2026-03-25success
$RYTMimcivree2026-03-19success
$ASNDyuviwel2026-02-27success
$BMRNpalynziq2026-02-27success
$ETONdesmoda2026-02-25success

Recent insider activity· ±90 days

17 insiders · 0 buys · 20 sells
Sell
2025-12-09
Henderson Mary Elizabeth
SVP, Technical Operations
2,238 @ $169.51$379K
Sell
2025-12-05
Carr Patricia
SVP, Chief Accounting Officer
160 @ $171.11$27K
Exercise
2025-12-05
Carr Patricia
SVP, Chief Accounting Officer
4,500 @ $140.67$633K
Tax
2025-12-05
GALA RENEE D
President & CEO
80 @ $166.91$13K
Sell
2025-12-05
Carr Patricia
SVP, Chief Accounting Officer
4,500 @ $171.20$770K
Tax
2025-12-02
O'Keefe Kenneth W
Director
603 @ $173.07$104K
Sell
2025-11-26
COZADD BRUCE C
Director
38,126 @ $177.27$6.76M
Exercise
2025-11-26
COZADD BRUCE C
Director
76,689 @ $123.36$9.46M
Sell
2025-11-26
COZADD BRUCE C
Director
8,380 @ $179.23$1.50M
Sell
2025-11-26
COZADD BRUCE C
Director
30,487 @ $178.06$5.43M
Exercise
2025-11-26
COZADD BRUCE C
Director
811 @ $123.36$100K
Sell
2025-11-26
COZADD BRUCE C
Director
507 @ $179.79$91K
Exercise
2025-11-20
McSharry Heather Ann
Director
3,415 @ $138.08$472K
Sell
2025-11-20
McSharry Heather Ann
Director
3,415 @ $177.78$607K
Grant
2025-11-20
COZADD BRUCE C
Director
2,506 @ ——
Disp
2025-11-19
Henderson Mary Elizabeth
SVP, Technical Operations
1,331 @ $180.40$240K
Sell
2025-11-18
COZADD BRUCE C
Director
5,517 @ $181.81$1.00M
Sell
2025-11-18
Winningham Rick E
Director
5,500 @ $180.86$995K
Sell
2025-11-18
Carr Patricia
SVP, Chief Accounting Officer
69 @ $181.66$13K
Exercise
2025-11-18
Carr Patricia
SVP, Chief Accounting Officer
5,250 @ $136.18$715K
Sell
2025-11-18
Carr Patricia
SVP, Chief Accounting Officer
5,250 @ $182.07$956K
Sell
2025-11-18
COZADD BRUCE C
Director
3,384 @ $180.09$609K
Sell
2025-11-18
COZADD BRUCE C
Director
8,382 @ $180.88$1.52M
Sell
2025-11-18
COZADD BRUCE C
Director
717 @ $182.60$131K
Sell10b5-1
2025-11-17
Iannone Robert
EVP, Global Head of R&D & CMO
7,159 @ $168.26$1.20M
Sell10b5-1
2025-10-03
COZADD BRUCE C
Director
3,500 @ $140.00$490K
Sell10b5-1
2025-10-01
COZADD BRUCE C
Director
2,000 @ $131.78$264K
Tax
2025-09-14
COZADD BRUCE C
Director
15,647 @ $126.16$1.97M
Sell10b5-1
2025-09-02
COZADD BRUCE C
Director
3,000 @ $127.23$382K
Other
2025-08-18
ENRIGHT PATRICK G
Director
5,000 @ ——
Tax
2025-08-08
Smith Mark Douglas
Director
1,805 @ $111.25$201K
Tax
2025-08-08
ENRIGHT PATRICK G
Director
1,805 @ $111.25$201K
Tax
2025-08-08
Hamill Laura
Director
1,805 @ $111.25$201K
Tax
2025-08-08
ORiordan Anne
Director
1,805 @ $111.25$201K
Tax
2025-08-08
Winningham Rick E
Director
1,805 @ $111.25$201K
Tax
2025-08-08
Kennedy Patrick
Director
1,959 @ $111.25$218K
Tax
2025-08-08
Cook Jennifer E.
Director
1,805 @ $111.25$201K
Tax
2025-08-08
RIEDEL NORBERT G
Director
1,805 @ $111.25$201K
Tax
2025-08-08
O'Keefe Kenneth W
Director
1,805 @ $111.25$201K
Tax
2025-08-08
McSharry Heather Ann
Director
1,959 @ $111.25$218K
Grant
2025-08-07
Mulligan Seamus
Director
3,507 @ ——
Grant
2025-08-07
Cook Jennifer E.
Director
3,507 @ ——
Grant
2025-08-07
ORiordan Anne
Director
3,507 @ ——
Grant
2025-08-07
Kennedy Patrick
Director
3,507 @ ——
Grant
2025-08-07
O'Keefe Kenneth W
Director
3,507 @ ——
Grant
2025-08-07
Hamill Laura
Director
3,507 @ ——
Grant
2025-08-07
ENRIGHT PATRICK G
Director
3,507 @ ——
Grant
2025-08-07
GALA RENEE D
President & CEO
18,808 @ ——
Grant
2025-08-07
McSharry Heather Ann
Director
3,507 @ ——
Grant
2025-08-07
RIEDEL NORBERT G
Director
3,507 @ ——
+ 4 more
← All catalysts for $JAZZ