FDA approvaloutcome: successconf 1.00

vyxeos — FDA approval

$JAZZ · Jazz Pharmaceuticals plc

Event date

September 27, 2022

1348 days ago

Sponsor runway

cash-flow +

$1.84B liquid

Evidence

“openFDA SUPPL (EFFICACY) approval of VYXEOS — application NDA209401”

Source ↗

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

100% hit rate (10/10)

Ticker	Drug	Date	Outcome
$INCY	zynyz	2026-05-18	success
$INCY	jakafi xr	2026-05-01	success
$AXSM	auvelity	2026-04-30	success
$INCY	zynyz	2026-03-30	success
$BIIB	spinraza	2026-03-27	success
$CORT	lifyorli	2026-03-25	success
$RYTM	imcivree	2026-03-19	success
$ASND	yuviwel	2026-02-27	success
$BMRN	palynziq	2026-02-27	success
$ETON	desmoda	2026-02-25	success

Recent insider activity· ±90 days

20 insiders · 0 buys · 53 sells

Sell

2022-12-21

GALA RENEE D

President & CEO

2,635 @ $160.00$422K

Sell

2022-12-13

Pearce Samantha

EVP, Chief Commercial Officer

531 @ $155.45$83K

Exercise

2022-12-13

Pearce Samantha

EVP, Chief Commercial Officer

531 @ $109.45$58K

Sell

2022-12-09

Iannone Robert

EVP, Global Head of R&D & CMO

1,844 @ $151.54$279K

Sell

2022-12-05

Carr Patricia

SVP, Chief Accounting Officer

63 @ $152.06$10K

Other

2022-12-05

Swisher Daniel N JR

President and COO

10,465 @ ——

Sell

2022-12-02

Cook Jennifer E.

Director

420 @ $154.68$65K

Sell

2022-12-02

Smith Mark Douglas

Director

420 @ $154.68$65K

Sell

2022-12-01

COZADD BRUCE C

Director

1,000 @ $157.00$157K

Sell

2022-11-22

ENRIGHT PATRICK G

Director

2,905 @ $149.18$433K

Sell

2022-11-22

ENRIGHT PATRICK G

Director

2,000 @ $152.88$306K

Sell

2022-11-22

ENRIGHT PATRICK G

Director

2,069 @ $149.90$310K

Sell

2022-11-16

Patil Neena M

EVP & Chief Legal Officer

3,510 @ $142.34$500K

Sell

2022-11-14

Larkin Finbar

SVP, Technical Operations

197 @ $149.33$29K

Sell

2022-11-10

Pearce Samantha

EVP, Chief Commercial Officer

532 @ $155.00$82K

Sell

2022-11-10

Pearce Samantha

EVP, Chief Commercial Officer

531 @ $155.00$82K

Exercise

2022-11-10

Pearce Samantha

EVP, Chief Commercial Officer

531 @ $109.45$58K

Exercise

2022-11-10

Pearce Samantha

EVP, Chief Commercial Officer

532 @ $109.45$58K

Sell

2022-11-10

COZADD BRUCE C

Director

2,000 @ $150.00$300K

Exercise

2022-10-03

COZADD BRUCE C

Director

62,905 @ $59.13$3.72M

Sell

2022-10-03

COZADD BRUCE C

Director

7,748 @ $135.80$1.05M

Sell

2022-10-03

COZADD BRUCE C

Director

23,646 @ $135.18$3.20M

Sell

2022-10-03

COZADD BRUCE C

Director

13,791 @ $134.02$1.85M

Sell

2022-09-07

Larkin Finbar

SVP, Technical Operations

63 @ $150.00$9K

Sell

2022-09-06

COZADD BRUCE C

Director

1,000 @ $155.10$155K

Sell

2022-09-06

COZADD BRUCE C

Director

474 @ $154.31$73K

Sell

2022-09-06

COZADD BRUCE C

Director

542 @ $155.22$84K

Sell

2022-09-06

COZADD BRUCE C

Director

1,170 @ $153.13$179K

Sell

2022-09-06

COZADD BRUCE C

Director

4,517 @ $152.41$688K

Exercise

2022-09-06

COZADD BRUCE C

Director

9,700 @ $59.13$574K

Sell

2022-09-02

Pearce Samantha

EVP, Chief Commercial Officer

531 @ $156.98$83K

Exercise

2022-09-02

Pearce Samantha

EVP, Chief Commercial Officer

531 @ $109.45$58K

Exercise

2022-08-18

Gray Peter

Director

8,000 @ $55.28$442K

Sell

2022-08-18

Gray Peter

Director

8,000 @ $158.00$1.26M

Sell

2022-08-15

Carr Patricia

SVP, Chief Accounting Officer

2,000 @ $160.29$321K

Sell

2022-08-15

Carr Patricia

SVP, Chief Accounting Officer

142 @ $156.86$22K

Exercise

2022-08-15

Carr Patricia

SVP, Chief Accounting Officer

2,000 @ $113.10$226K

Sell

2022-08-08

Winningham Rick E

Director

1,089 @ $152.32$166K

Sell

2022-08-08

McSharry Heather Ann

Director

1,179 @ $152.32$180K

Exercise

2022-08-08

McSharry Heather Ann

Director

8,000 @ $55.28$442K

Sell

2022-08-08

McSharry Heather Ann

Director

5,500 @ $154.59$850K

Sell

2022-08-08

ENRIGHT PATRICK G

Director

1,089 @ $152.33$166K

Sell

2022-08-08

Gray Peter

Director

1,179 @ $152.32$180K

Sell

2022-08-08

Sohn Catherine A.

Director

1,089 @ $152.32$166K

Sell

2022-08-08

RIEDEL NORBERT G

Director

1,089 @ $152.32$166K

Sell

2022-08-08

Smith Mark Douglas

Director

1,089 @ $152.32$166K

Sell

2022-08-08

Carr Patricia

SVP, Chief Accounting Officer

158 @ $152.33$24K

Sell

2022-08-08

Cook Jennifer E.

Director

1,089 @ $152.32$166K

Sell

2022-08-08

ORiordan Anne

Director

1,089 @ $152.32$166K

Sell

2022-08-08

O'Keefe Kenneth W

Director

1,089 @ $152.33$166K

+ 32 more

Date	Insider	Action	Shares	Price	Value
2022-12-21	GALA RENEE DPresident & CEO	Sell	2,635	$160.00	$422K
2022-12-13	Pearce SamanthaEVP, Chief Commercial Officer	Sell	531	$155.45	$83K
2022-12-13	Pearce SamanthaEVP, Chief Commercial Officer	Exercise	531	$109.45	$58K
2022-12-09	Iannone RobertEVP, Global Head of R&D & CMO	Sell	1,844	$151.54	$279K
2022-12-05	Carr PatriciaSVP, Chief Accounting Officer	Sell	63	$152.06	$10K
2022-12-05	Swisher Daniel N JRPresident and COO	Other	10,465	—	—
2022-12-02	Cook Jennifer E.Director	Sell	420	$154.68	$65K
2022-12-02	Smith Mark DouglasDirector	Sell	420	$154.68	$65K
2022-12-01	COZADD BRUCE CDirector	Sell	1,000	$157.00	$157K
2022-11-22	ENRIGHT PATRICK GDirector	Sell	2,905	$149.18	$433K
2022-11-22	ENRIGHT PATRICK GDirector	Sell	2,000	$152.88	$306K
2022-11-22	ENRIGHT PATRICK GDirector	Sell	2,069	$149.90	$310K
2022-11-16	Patil Neena MEVP & Chief Legal Officer	Sell	3,510	$142.34	$500K
2022-11-14	Larkin FinbarSVP, Technical Operations	Sell	197	$149.33	$29K
2022-11-10	Pearce SamanthaEVP, Chief Commercial Officer	Sell	532	$155.00	$82K
2022-11-10	Pearce SamanthaEVP, Chief Commercial Officer	Sell	531	$155.00	$82K
2022-11-10	Pearce SamanthaEVP, Chief Commercial Officer	Exercise	531	$109.45	$58K
2022-11-10	Pearce SamanthaEVP, Chief Commercial Officer	Exercise	532	$109.45	$58K
2022-11-10	COZADD BRUCE CDirector	Sell	2,000	$150.00	$300K
2022-10-03	COZADD BRUCE CDirector	Exercise	62,905	$59.13	$3.72M
2022-10-03	COZADD BRUCE CDirector	Sell	7,748	$135.80	$1.05M
2022-10-03	COZADD BRUCE CDirector	Sell	23,646	$135.18	$3.20M
2022-10-03	COZADD BRUCE CDirector	Sell	13,791	$134.02	$1.85M
2022-09-07	Larkin FinbarSVP, Technical Operations	Sell	63	$150.00	$9K
2022-09-06	COZADD BRUCE CDirector	Sell	1,000	$155.10	$155K
2022-09-06	COZADD BRUCE CDirector	Sell	474	$154.31	$73K
2022-09-06	COZADD BRUCE CDirector	Sell	542	$155.22	$84K
2022-09-06	COZADD BRUCE CDirector	Sell	1,170	$153.13	$179K
2022-09-06	COZADD BRUCE CDirector	Sell	4,517	$152.41	$688K
2022-09-06	COZADD BRUCE CDirector	Exercise	9,700	$59.13	$574K
2022-09-02	Pearce SamanthaEVP, Chief Commercial Officer	Sell	531	$156.98	$83K
2022-09-02	Pearce SamanthaEVP, Chief Commercial Officer	Exercise	531	$109.45	$58K
2022-08-18	Gray PeterDirector	Exercise	8,000	$55.28	$442K
2022-08-18	Gray PeterDirector	Sell	8,000	$158.00	$1.26M
2022-08-15	Carr PatriciaSVP, Chief Accounting Officer	Sell	2,000	$160.29	$321K
2022-08-15	Carr PatriciaSVP, Chief Accounting Officer	Sell	142	$156.86	$22K
2022-08-15	Carr PatriciaSVP, Chief Accounting Officer	Exercise	2,000	$113.10	$226K
2022-08-08	Winningham Rick EDirector	Sell	1,089	$152.32	$166K
2022-08-08	McSharry Heather AnnDirector	Sell	1,179	$152.32	$180K
2022-08-08	McSharry Heather AnnDirector	Exercise	8,000	$55.28	$442K
2022-08-08	McSharry Heather AnnDirector	Sell	5,500	$154.59	$850K
2022-08-08	ENRIGHT PATRICK GDirector	Sell	1,089	$152.33	$166K
2022-08-08	Gray PeterDirector	Sell	1,179	$152.32	$180K
2022-08-08	Sohn Catherine A.Director	Sell	1,089	$152.32	$166K
2022-08-08	RIEDEL NORBERT GDirector	Sell	1,089	$152.32	$166K
2022-08-08	Smith Mark DouglasDirector	Sell	1,089	$152.32	$166K
2022-08-08	Carr PatriciaSVP, Chief Accounting Officer	Sell	158	$152.33	$24K
2022-08-08	Cook Jennifer E.Director	Sell	1,089	$152.32	$166K
2022-08-08	ORiordan AnneDirector	Sell	1,089	$152.32	$166K
2022-08-08	O'Keefe Kenneth WDirector	Sell	1,089	$152.33	$166K

+ 32 more transactions

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