Yeji
FDA approvalconf 0.97

lumryz — FDA approval

$JAZZ · Jazz Pharmaceuticals plc · cataplexy or excessive daytime sleepiness (EDS) in adult patients with narcolepsy
Event date
May 1, 2023
1132 days ago
Sponsor runway
cash-flow +
$1.84B liquid

Evidence

“Jazz Pharmaceuticals, Inc. ... filed a complaint in the United States District Court for the District of Columbia ... seeking a declaration that the U.S. Food and Drug Administration's ("FDA") approval on May 1, 2023 of the New Drug Application ("NDA") for Lumryz TM , an extended-release reformulation of Jazz's high sodium oxybate product Xyrem®, for the treatment of cataplexy or excessive daytime sleepiness ("EDS") in adult patients with narcolepsy, was unlawful.”
Source: 8-K filed 2023-06-22View on EDGAR ↗0001193125-23-172528

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

Recent insider activity· ±90 days

11 insiders · 0 buys · 13 sells
Exercise
2023-06-08
Mulligan Seamus
Director
4,500 @ $81.76$368K
Sell
2023-06-07
Carr Patricia
SVP, Chief Accounting Officer
126 @ $127.92$16K
Disp
2023-06-05
Sablich Kim
EVP, GM of U.S.
2,082 @ $129.73$270K
Disp
2023-06-05
Iannone Robert
EVP, Global Head of R&D & CMO
1,311 @ $129.73$170K
Sell
2023-06-01
Patil Neena M
EVP & Chief Legal Officer
1,526 @ $127.98$195K
Sell
2023-06-01
Patil Neena M
EVP & Chief Legal Officer
74 @ $128.01$9K
Sell
2023-05-18
GALA RENEE D
President & CEO
6,000 @ $131.75$790K
Tax
2023-04-05
GALA RENEE D
President & CEO
1,807 @ $145.78$263K
Sell
2023-03-15
Carr Patricia
SVP, Chief Accounting Officer
1,023 @ $133.22$136K
Sell
2023-03-08
Sablich Kim
EVP, GM of U.S.
1,261 @ $140.19$177K
Sell
2023-03-08
Sablich Kim
EVP, GM of U.S.
1,752 @ $139.42$244K
Sell
2023-03-07
O'Keefe Kenneth W
Director
2,690 @ $138.39$372K
Exercise
2023-03-07
O'Keefe Kenneth W
Director
4,500 @ $81.76$368K
Sell
2023-03-07
Larkin Finbar
SVP, Technical Operations
2,075 @ $140.76$292K
Sell
2023-03-06
Larkin Finbar
SVP, Technical Operations
1,706 @ $143.92$246K
Exercise
2023-03-06
Larkin Finbar
SVP, Technical Operations
1,706 @ $58.72$100K
Tax
2023-03-05
Patil Neena M
EVP & Chief Legal Officer
1,923 @ $142.78$275K
Sell
2023-03-05
Carr Patricia
SVP, Chief Accounting Officer
1,148 @ $140.76$162K
Tax
2023-03-05
COZADD BRUCE C
Director
21,882 @ $142.78$3.12M
Tax
2023-03-05
Iannone Robert
EVP, Global Head of R&D & CMO
2,274 @ $142.78$325K
Tax
2023-03-05
Pearce Samantha
EVP, Chief Commercial Officer
2,020 @ $142.78$288K
Tax
2023-03-05
Swisher Daniel N JR
President and COO
5,426 @ $142.78$775K
Tax
2023-03-05
Sablich Kim
EVP, GM of U.S.
1,610 @ $142.78$230K
Tax
2023-03-05
GALA RENEE D
President & CEO
1,557 @ $142.78$222K
Exercise
2023-03-04
Mulligan Seamus
Director
4,500 @ $59.13$266K
Grant
2023-03-03
Iannone Robert
EVP, Global Head of R&D & CMO
12,447 @ ——
Grant
2023-03-03
Swisher Daniel N JR
President and COO
13,456 @ ——
Grant
2023-03-03
COZADD BRUCE C
Director
42,388 @ ——
Grant
2023-03-03
Sablich Kim
EVP, GM of U.S.
10,429 @ ——
Grant
2023-03-03
GALA RENEE D
President & CEO
12,784 @ ——
Grant
2023-03-03
Patil Neena M
EVP & Chief Legal Officer
9,419 @ ——
Grant
2023-03-03
Carr Patricia
SVP, Chief Accounting Officer
2,523 @ ——
Grant
2023-03-03
Pearce Samantha
EVP, Chief Commercial Officer
3,870 @ ——
Grant
2023-03-03
Larkin Finbar
SVP, Technical Operations
4,373 @ ——
Sell
2023-02-02
Pearce Samantha
EVP, Chief Commercial Officer
531 @ $157.26$84K
Exercise
2023-02-02
Pearce Samantha
EVP, Chief Commercial Officer
531 @ $109.45$58K
Sell
2023-02-01
COZADD BRUCE C
Director
1,000 @ $155.79$156K
← All catalysts for $JAZZ