FDA approvaloutcome: successconf 1.00

zynyz — FDA approval

$INCY · INCYTE CORP

Event date

December 17, 2025

171 days ago

Sponsor runway

cash-flow +

$3.46B liquid

Evidence

“openFDA SUPPL (EFFICACY) approval of ZYNYZ — application BLA761334”

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

15 insiders · 0 buys · 23 sells

Exercise10b5-1

2026-03-17

CAGNONI PABLO J

President, Global Head of R&D

7,166 @ $61.18$438K

Sell10b5-1

2026-03-17

CAGNONI PABLO J

President, Global Head of R&D

18,667 @ $94.24$1.76M

Exercise10b5-1

2026-03-17

CAGNONI PABLO J

President, Global Head of R&D

11,501 @ $64.25$739K

Exercise10b5-1

2026-02-19

CAGNONI PABLO J

President, Global Head of R&D

5,575 @ $61.18$341K

Sell10b5-1

2026-02-19

CAGNONI PABLO J

President, Global Head of R&D

18,668 @ $100.91$1.88M

Exercise10b5-1

2026-02-19

CAGNONI PABLO J

President, Global Head of R&D

13,093 @ $61.76$809K

Tax

2026-02-02

Morrissey Michael James

EVP, Head of Tech. Operations

185 @ $102.67$19K

Tax

2026-02-02

Heeson Lee

EVP, Head of Incyte Intl

111 @ $102.67$11K

Tax

2026-01-20

Morrissey Michael James

EVP, Head of Tech. Operations

429 @ $102.62$44K

Grant

2026-01-16

CAGNONI PABLO J

President, Global Head of R&D

28,475 @ ——

Grant

2026-01-16

Heeson Lee

EVP, Head of Incyte Intl

8,911 @ ——

Grant

2026-01-16

Stein Steven H

CMO & Head of Late-Stage Dev.

19,932 @ ——

Grant

2026-01-16

Issa Mohamed Khairie

EVP, Head of US Oncology

14,237 @ ——

Grant

2026-01-16

Trotta Matteo

EVP, GM, Dermatology US

8,542 @ ——

Grant

2026-01-16

Tray Thomas

Principal Accounting Officer

2,425 @ ——

Grant

2026-01-16

Mayes Patrick A

EVP & Chief Scientific Officer

4,218 @ ——

Grant

2026-01-16

Morrissey Michael James

EVP, Head of Tech. Operations

7,426 @ ——

Sell10b5-1

2026-01-07

Issa Mohamed Khairie

EVP, Head of US Oncology

10,856 @ $109.07$1.18M

Tax10b5-1

2026-01-06

Issa Mohamed Khairie

EVP, Head of US Oncology

8,264 @ $106.66$881K

Sell10b5-1

2026-01-05

Stein Steven H

CMO & Head of Late-Stage Dev.

15,634 @ $101.70$1.59M

Grant

2025-12-31

Clancy Paul J

Director

241 @ $98.77$24K

Grant

2025-12-31

HARRIGAN EDMUND

Director

245 @ $98.77$24K

Tax

2025-12-31

Stein Steven H

CMO & Head of Late-Stage Dev.

13,292 @ $98.77$1.31M

Tax

2025-12-31

Morrissey Michael James

EVP, Head of Tech. Operations

254 @ $98.77$25K

Grant

2025-12-31

BAKER BROS. ADVISORS LP

Director

328 @ ——

Exercise10b5-1

2025-12-19

Tray Thomas

Principal Accounting Officer

1,044 @ $95.76$100K

Exercise10b5-1

2025-12-19

Tray Thomas

Principal Accounting Officer

1,730 @ $95.76$166K

Sell10b5-1

2025-12-19

Tray Thomas

Principal Accounting Officer

2,774 @ $100.00$277K

Sell10b5-1

2025-12-18

Tray Thomas

Principal Accounting Officer

600 @ $98.25$59K

Sell10b5-1

2025-12-17

Morrissey Michael James

EVP, Head of Tech. Operations

4,323 @ $97.26$420K

Sell10b5-1

2025-12-16

Morrissey Michael James

EVP, Head of Tech. Operations

833 @ $97.42$81K

Sell10b5-1

2025-12-16

Morrissey Michael James

EVP, Head of Tech. Operations

53,175 @ $97.29$5.17M

Sell10b5-1

2025-12-11

Mayes Patrick A

EVP & Chief Scientific Officer

255 @ $94.94$24K

Sell10b5-1

2025-12-10

Mayes Patrick A

EVP & Chief Scientific Officer

5,553 @ $95.58$531K

Tax

2025-12-08

Hoppenot Herve

Director

2,843 @ $96.70$275K

Sell10b5-1

2025-12-02

Stein Steven H

CMO & Head of Late-Stage Dev.

20,105 @ $102.51$2.06M

Tax10b5-1

2025-12-01

Stein Steven H

CMO & Head of Late-Stage Dev.

17,093 @ $102.04$1.74M

Sell10b5-1

2025-12-01

Stein Steven H

CMO & Head of Late-Stage Dev.

2,559 @ $102.96$263K

Grant

2025-12-01

Hoffman Richard A.

EVP & General Counsel

9,466 @ ——

Grant

2025-12-01

Hoffman Richard A.

EVP & General Counsel

43,301 @ ——

Grant

2025-12-01

Hoffman Richard A.

EVP & General Counsel

23,665 @ ——

Tax

2025-12-01

Morrissey Michael James

EVP, Head of Tech. Operations

326 @ $102.04$33K

Sell10b5-1

2025-11-24

Tray Thomas

Principal Accounting Officer

600 @ $103.00$62K

Sell10b5-1

2025-11-21

Tray Thomas

Principal Accounting Officer

169 @ $102.00$17K

Exercise10b5-1

2025-11-17

Denton Sheila A.

EVP & General Counsel

278 @ $64.25$18K

Sell10b5-1

2025-11-17

Denton Sheila A.

EVP & General Counsel

278 @ $104.36$29K

Sell10b5-1

2025-11-10

Hoppenot Herve

Director

187,500 @ $105.46$19.77M

Exercise10b5-1

2025-11-05

Stein Steven H

CMO & Head of Late-Stage Dev.

1,194 @ $83.83$100K

Exercise10b5-1

2025-11-05

Stein Steven H

CMO & Head of Late-Stage Dev.

2,995 @ $95.76$287K

Exercise10b5-1

2025-11-05

Stein Steven H

CMO & Head of Late-Stage Dev.

1,044 @ $95.76$100K

+ 18 more

Date	Insider	Action	Shares	Price	Value
2026-03-17	CAGNONI PABLO JPresident, Global Head of R&D	Exercise10b5-1	7,166	$61.18	$438K
2026-03-17	CAGNONI PABLO JPresident, Global Head of R&D	Sell10b5-1	18,667	$94.24	$1.76M
2026-03-17	CAGNONI PABLO JPresident, Global Head of R&D	Exercise10b5-1	11,501	$64.25	$739K
2026-02-19	CAGNONI PABLO JPresident, Global Head of R&D	Exercise10b5-1	5,575	$61.18	$341K
2026-02-19	CAGNONI PABLO JPresident, Global Head of R&D	Sell10b5-1	18,668	$100.91	$1.88M
2026-02-19	CAGNONI PABLO JPresident, Global Head of R&D	Exercise10b5-1	13,093	$61.76	$809K
2026-02-02	Morrissey Michael JamesEVP, Head of Tech. Operations	Tax	185	$102.67	$19K
2026-02-02	Heeson LeeEVP, Head of Incyte Intl	Tax	111	$102.67	$11K
2026-01-20	Morrissey Michael JamesEVP, Head of Tech. Operations	Tax	429	$102.62	$44K
2026-01-16	CAGNONI PABLO JPresident, Global Head of R&D	Grant	28,475	—	—
2026-01-16	Heeson LeeEVP, Head of Incyte Intl	Grant	8,911	—	—
2026-01-16	Stein Steven HCMO & Head of Late-Stage Dev.	Grant	19,932	—	—
2026-01-16	Issa Mohamed KhairieEVP, Head of US Oncology	Grant	14,237	—	—
2026-01-16	Trotta MatteoEVP, GM, Dermatology US	Grant	8,542	—	—
2026-01-16	Tray ThomasPrincipal Accounting Officer	Grant	2,425	—	—
2026-01-16	Mayes Patrick AEVP & Chief Scientific Officer	Grant	4,218	—	—
2026-01-16	Morrissey Michael JamesEVP, Head of Tech. Operations	Grant	7,426	—	—
2026-01-07	Issa Mohamed KhairieEVP, Head of US Oncology	Sell10b5-1	10,856	$109.07	$1.18M
2026-01-06	Issa Mohamed KhairieEVP, Head of US Oncology	Tax10b5-1	8,264	$106.66	$881K
2026-01-05	Stein Steven HCMO & Head of Late-Stage Dev.	Sell10b5-1	15,634	$101.70	$1.59M
2025-12-31	Clancy Paul JDirector	Grant	241	$98.77	$24K
2025-12-31	HARRIGAN EDMUNDDirector	Grant	245	$98.77	$24K
2025-12-31	Stein Steven HCMO & Head of Late-Stage Dev.	Tax	13,292	$98.77	$1.31M
2025-12-31	Morrissey Michael JamesEVP, Head of Tech. Operations	Tax	254	$98.77	$25K
2025-12-31	BAKER BROS. ADVISORS LPDirector	Grant	328	—	—
2025-12-19	Tray ThomasPrincipal Accounting Officer	Exercise10b5-1	1,044	$95.76	$100K
2025-12-19	Tray ThomasPrincipal Accounting Officer	Exercise10b5-1	1,730	$95.76	$166K
2025-12-19	Tray ThomasPrincipal Accounting Officer	Sell10b5-1	2,774	$100.00	$277K
2025-12-18	Tray ThomasPrincipal Accounting Officer	Sell10b5-1	600	$98.25	$59K
2025-12-17	Morrissey Michael JamesEVP, Head of Tech. Operations	Sell10b5-1	4,323	$97.26	$420K
2025-12-16	Morrissey Michael JamesEVP, Head of Tech. Operations	Sell10b5-1	833	$97.42	$81K
2025-12-16	Morrissey Michael JamesEVP, Head of Tech. Operations	Sell10b5-1	53,175	$97.29	$5.17M
2025-12-11	Mayes Patrick AEVP & Chief Scientific Officer	Sell10b5-1	255	$94.94	$24K
2025-12-10	Mayes Patrick AEVP & Chief Scientific Officer	Sell10b5-1	5,553	$95.58	$531K
2025-12-08	Hoppenot HerveDirector	Tax	2,843	$96.70	$275K
2025-12-02	Stein Steven HCMO & Head of Late-Stage Dev.	Sell10b5-1	20,105	$102.51	$2.06M
2025-12-01	Stein Steven HCMO & Head of Late-Stage Dev.	Tax10b5-1	17,093	$102.04	$1.74M
2025-12-01	Stein Steven HCMO & Head of Late-Stage Dev.	Sell10b5-1	2,559	$102.96	$263K
2025-12-01	Hoffman Richard A.EVP & General Counsel	Grant	9,466	—	—
2025-12-01	Hoffman Richard A.EVP & General Counsel	Grant	43,301	—	—
2025-12-01	Hoffman Richard A.EVP & General Counsel	Grant	23,665	—	—
2025-12-01	Morrissey Michael JamesEVP, Head of Tech. Operations	Tax	326	$102.04	$33K
2025-11-24	Tray ThomasPrincipal Accounting Officer	Sell10b5-1	600	$103.00	$62K
2025-11-21	Tray ThomasPrincipal Accounting Officer	Sell10b5-1	169	$102.00	$17K
2025-11-17	Denton Sheila A.EVP & General Counsel	Exercise10b5-1	278	$64.25	$18K
2025-11-17	Denton Sheila A.EVP & General Counsel	Sell10b5-1	278	$104.36	$29K
2025-11-10	Hoppenot HerveDirector	Sell10b5-1	187,500	$105.46	$19.77M
2025-11-05	Stein Steven HCMO & Head of Late-Stage Dev.	Exercise10b5-1	1,194	$83.83	$100K
2025-11-05	Stein Steven HCMO & Head of Late-Stage Dev.	Exercise10b5-1	2,995	$95.76	$287K
2025-11-05	Stein Steven HCMO & Head of Late-Stage Dev.	Exercise10b5-1	1,044	$95.76	$100K

+ 18 more transactions

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