FDA approvaloutcome: successconf 1.00

zynyz — FDA approval

$INCY · INCYTE CORP

Event date

May 15, 2025

387 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

22 insiders · 0 buys · 22 sells

Sell10b5-1

2025-08-04

Denton Sheila A.

EVP & General Counsel

598 @ $75.77$45K

Exercise10b5-1

2025-08-04

Denton Sheila A.

EVP & General Counsel

598 @ $58.06$35K

Sell10b5-1

2025-07-21

Stein Steven H

CMO & Head of Late-Stage Dev.

3,706 @ $67.94$252K

Sell10b5-1

2025-07-16

Iyengar Vijay K

EVP, GMAPPS

983 @ $68.36$67K

Sell10b5-1

2025-07-16

Denton Sheila A.

EVP & General Counsel

785 @ $68.36$54K

Sell10b5-1

2025-07-16

Flannelly Barry P

EVP & General Manager US

1,340 @ $68.36$92K

Grant

2025-07-15

CAGNONI PABLO J

President, Global Head of R&D

17,538 @ ——

Tax

2025-07-15

Tray Thomas

Principal Accounting Officer

583 @ $68.25$40K

Grant

2025-07-15

Tray Thomas

Principal Accounting Officer

4,482 @ ——

Grant

2025-07-15

Tray Thomas

Principal Accounting Officer

3,362 @ ——

Grant

2025-07-15

CAGNONI PABLO J

President, Global Head of R&D

39,471 @ ——

Tax

2025-07-15

CAGNONI PABLO J

President, Global Head of R&D

2,628 @ $68.25$179K

Grant

2025-07-15

Issa Mohamed Khairie

EVP, Head of US Oncology

19,735 @ ——

Grant

2025-07-15

Morrissey Michael James

EVP, Head of Tech. Operations

10,961 @ ——

Grant

2025-07-15

Issa Mohamed Khairie

EVP, Head of US Oncology

21,923 @ ——

Tax

2025-07-15

Hoppenot Herve

Director

4,713 @ $68.25$322K

Tax

2025-07-15

SWAIN PAULA J

EVP, Human Resources

563 @ $68.25$38K

Grant

2025-07-15

Issa Mohamed Khairie

EVP, Head of US Oncology

8,769 @ ——

Tax10b5-1

2025-07-15

Denton Sheila A.

EVP & General Counsel

703 @ $68.25$48K

Exercise10b5-1

2025-07-15

Denton Sheila A.

EVP & General Counsel

3,330 @ $64.25$214K

Sell10b5-1

2025-07-15

Denton Sheila A.

EVP & General Counsel

3,330 @ $69.86$233K

Grant

2025-07-15

SWAIN PAULA J

EVP, Human Resources

16,077 @ ——

Grant

2025-07-15

SWAIN PAULA J

EVP, Human Resources

14,472 @ ——

Grant

2025-07-15

CAGNONI PABLO J

President, Global Head of R&D

43,846 @ ——

Grant10b5-1

2025-07-15

Iyengar Vijay K

EVP, GMAPPS

6,430 @ ——

Grant10b5-1

2025-07-15

Iyengar Vijay K

EVP, GMAPPS

16,077 @ ——

Grant10b5-1

2025-07-15

Iyengar Vijay K

EVP, GMAPPS

14,472 @ ——

Grant

2025-07-15

Heeson Lee

EVP, Head of Incyte Intl

6,577 @ ——

Grant10b5-1

2025-07-15

Denton Sheila A.

EVP & General Counsel

18,419 @ ——

Grant10b5-1

2025-07-15

Denton Sheila A.

EVP & General Counsel

20,461 @ ——

Tax10b5-1

2025-07-15

Stein Steven H

CMO & Head of Late-Stage Dev.

1,596 @ $68.25$109K

Grant10b5-1

2025-07-15

Stein Steven H

CMO & Head of Late-Stage Dev.

12,277 @ ——

Grant10b5-1

2025-07-15

Stein Steven H

CMO & Head of Late-Stage Dev.

30,692 @ ——

Grant10b5-1

2025-07-15

Stein Steven H

CMO & Head of Late-Stage Dev.

27,629 @ ——

Grant

2025-07-15

SWAIN PAULA J

EVP, Human Resources

6,430 @ ——

Grant10b5-1

2025-07-15

Denton Sheila A.

EVP & General Counsel

8,184 @ ——

Grant

2025-07-15

Stamoulis Christiana

EVP & Chief Financial Officer

24,998 @ ——

Grant

2025-07-15

Stamoulis Christiana

EVP & Chief Financial Officer

27,769 @ ——

Tax

2025-07-15

Trotta Matteo

EVP, GM, Dermatology US

182 @ $68.25$12K

Grant

2025-07-15

Trotta Matteo

EVP, GM, Dermatology US

5,261 @ ——

Grant

2025-07-15

Trotta Matteo

EVP, GM, Dermatology US

13,154 @ ——

Grant

2025-07-15

Trotta Matteo

EVP, GM, Dermatology US

11,841 @ ——

Grant

2025-07-15

Stamoulis Christiana

EVP & Chief Financial Officer

11,107 @ ——

Tax

2025-07-15

Stamoulis Christiana

EVP & Chief Financial Officer

1,445 @ $68.25$99K

Tax10b5-1

2025-07-15

Flannelly Barry P

EVP & General Manager US

1,141 @ $68.25$78K

Sell10b5-1

2025-07-15

Flannelly Barry P

EVP & General Manager US

1,192 @ $69.86$83K

Sell10b5-1

2025-07-15

Iyengar Vijay K

EVP, GMAPPS

1,177 @ $69.86$82K

Tax10b5-1

2025-07-15

Iyengar Vijay K

EVP, GMAPPS

836 @ $68.25$57K

Tax10b5-1

2025-07-14

Iyengar Vijay K

EVP, GMAPPS

595 @ $69.98$42K

Tax

2025-07-14

CAGNONI PABLO J

President, Global Head of R&D

1,280 @ $69.98$90K

+ 75 more

Date	Insider	Action	Shares	Price	Value
2025-08-04	Denton Sheila A.EVP & General Counsel	Sell10b5-1	598	$75.77	$45K
2025-08-04	Denton Sheila A.EVP & General Counsel	Exercise10b5-1	598	$58.06	$35K
2025-07-21	Stein Steven HCMO & Head of Late-Stage Dev.	Sell10b5-1	3,706	$67.94	$252K
2025-07-16	Iyengar Vijay KEVP, GMAPPS	Sell10b5-1	983	$68.36	$67K
2025-07-16	Denton Sheila A.EVP & General Counsel	Sell10b5-1	785	$68.36	$54K
2025-07-16	Flannelly Barry PEVP & General Manager US	Sell10b5-1	1,340	$68.36	$92K
2025-07-15	CAGNONI PABLO JPresident, Global Head of R&D	Grant	17,538	—	—
2025-07-15	Tray ThomasPrincipal Accounting Officer	Tax	583	$68.25	$40K
2025-07-15	Tray ThomasPrincipal Accounting Officer	Grant	4,482	—	—
2025-07-15	Tray ThomasPrincipal Accounting Officer	Grant	3,362	—	—
2025-07-15	CAGNONI PABLO JPresident, Global Head of R&D	Grant	39,471	—	—
2025-07-15	CAGNONI PABLO JPresident, Global Head of R&D	Tax	2,628	$68.25	$179K
2025-07-15	Issa Mohamed KhairieEVP, Head of US Oncology	Grant	19,735	—	—
2025-07-15	Morrissey Michael JamesEVP, Head of Tech. Operations	Grant	10,961	—	—
2025-07-15	Issa Mohamed KhairieEVP, Head of US Oncology	Grant	21,923	—	—
2025-07-15	Hoppenot HerveDirector	Tax	4,713	$68.25	$322K
2025-07-15	SWAIN PAULA JEVP, Human Resources	Tax	563	$68.25	$38K
2025-07-15	Issa Mohamed KhairieEVP, Head of US Oncology	Grant	8,769	—	—
2025-07-15	Denton Sheila A.EVP & General Counsel	Tax10b5-1	703	$68.25	$48K
2025-07-15	Denton Sheila A.EVP & General Counsel	Exercise10b5-1	3,330	$64.25	$214K
2025-07-15	Denton Sheila A.EVP & General Counsel	Sell10b5-1	3,330	$69.86	$233K
2025-07-15	SWAIN PAULA JEVP, Human Resources	Grant	16,077	—	—
2025-07-15	SWAIN PAULA JEVP, Human Resources	Grant	14,472	—	—
2025-07-15	CAGNONI PABLO JPresident, Global Head of R&D	Grant	43,846	—	—
2025-07-15	Iyengar Vijay KEVP, GMAPPS	Grant10b5-1	6,430	—	—
2025-07-15	Iyengar Vijay KEVP, GMAPPS	Grant10b5-1	16,077	—	—
2025-07-15	Iyengar Vijay KEVP, GMAPPS	Grant10b5-1	14,472	—	—
2025-07-15	Heeson LeeEVP, Head of Incyte Intl	Grant	6,577	—	—
2025-07-15	Denton Sheila A.EVP & General Counsel	Grant10b5-1	18,419	—	—
2025-07-15	Denton Sheila A.EVP & General Counsel	Grant10b5-1	20,461	—	—
2025-07-15	Stein Steven HCMO & Head of Late-Stage Dev.	Tax10b5-1	1,596	$68.25	$109K
2025-07-15	Stein Steven HCMO & Head of Late-Stage Dev.	Grant10b5-1	12,277	—	—
2025-07-15	Stein Steven HCMO & Head of Late-Stage Dev.	Grant10b5-1	30,692	—	—
2025-07-15	Stein Steven HCMO & Head of Late-Stage Dev.	Grant10b5-1	27,629	—	—
2025-07-15	SWAIN PAULA JEVP, Human Resources	Grant	6,430	—	—
2025-07-15	Denton Sheila A.EVP & General Counsel	Grant10b5-1	8,184	—	—
2025-07-15	Stamoulis ChristianaEVP & Chief Financial Officer	Grant	24,998	—	—
2025-07-15	Stamoulis ChristianaEVP & Chief Financial Officer	Grant	27,769	—	—
2025-07-15	Trotta MatteoEVP, GM, Dermatology US	Tax	182	$68.25	$12K
2025-07-15	Trotta MatteoEVP, GM, Dermatology US	Grant	5,261	—	—
2025-07-15	Trotta MatteoEVP, GM, Dermatology US	Grant	13,154	—	—
2025-07-15	Trotta MatteoEVP, GM, Dermatology US	Grant	11,841	—	—
2025-07-15	Stamoulis ChristianaEVP & Chief Financial Officer	Grant	11,107	—	—
2025-07-15	Stamoulis ChristianaEVP & Chief Financial Officer	Tax	1,445	$68.25	$99K
2025-07-15	Flannelly Barry PEVP & General Manager US	Tax10b5-1	1,141	$68.25	$78K
2025-07-15	Flannelly Barry PEVP & General Manager US	Sell10b5-1	1,192	$69.86	$83K
2025-07-15	Iyengar Vijay KEVP, GMAPPS	Sell10b5-1	1,177	$69.86	$82K
2025-07-15	Iyengar Vijay KEVP, GMAPPS	Tax10b5-1	836	$68.25	$57K
2025-07-14	Iyengar Vijay KEVP, GMAPPS	Tax10b5-1	595	$69.98	$42K
2025-07-14	CAGNONI PABLO JPresident, Global Head of R&D	Tax	1,280	$69.98	$90K

+ 75 more transactions

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