Yeji
PDUFAoutcome: failureconf 0.95

kresladi — PDUFA

$RCKT · ROCKET PHARMACEUTICALS, INC. · Treatment of pediatric patients with severe leukocyte adhesion deficiency-I (LAD-I) due to biallelic variants in ITGB2 without an available human leukocyte antigen-matched sibling donor for allogeneic hematopoietic stem cell transplant
Event date
June 30, 2024
706 days ago
Sponsor runway
10 mo
$144.4M liquid

Evidence

“the U.S. Food and Drug Administration (FDA) has extended the Priority Review period for the Biologics License Application (BLA) for KRESLADI™ (marnetegragene autotemcel) for severe Leukocyte Adhesion Deficiency-I (LAD-I) by three months, to June 30, 2024, to allow additional time to review clarifying Chemistry, Manufacturing, and Controls (CMC) information submitted by Rocket in response to FDA information requests.”
Source: 8-K filed 2024-02-13View on EDGAR ↗0001140361-24-007462

Comparable historical pdufas· last 5 years · same indication

100% hit rate (1/1)
TickerDrugDateOutcome
$RCKTkresladi2026-03-28success

Recent insider activity· ±90 days

17 insiders · 0 buys · 17 sells
Grant
2024-09-26
Bjork Elisabeth
Director
607 @ ——
Grant
2024-09-26
Makker Gotham
Director
204 @ ——
Grant
2024-09-26
Makker Gotham
Director
303 @ ——
Grant
2024-09-09
Dolsten Mikael
Director
22,988 @ ——
Grant
2024-09-09
Dolsten Mikael
Director
27,545 @ ——
Sell
2024-08-16
Schwartz Jonathan David
See Remarks
2,710 @ $18.50$50K
Sell
2024-08-16
Shah Gaurav
CEO
9,650 @ $18.50$179K
Sell
2024-08-16
Wilson Martin
General Counsel
1,027 @ $18.50$19K
Sell
2024-08-16
Patel Kinnari
See Remarks
3,989 @ $18.50$74K
Sell
2024-08-16
Militello John
See Remarks
1,064 @ $18.50$20K
Sell
2024-07-22
Militello John
See Remarks
812 @ $23.02$19K
Sell
2024-07-08
White Mark Andrew
See Remarks
3,026 @ $20.39$62K
Grant
2024-06-13
Bjork Elisabeth
Director
3,325 @ $15.04$50K
Grant
2024-06-13
Yalamanchi Naveen
Director
23,944 @ ——
Grant
2024-06-13
Woods Keith
Director
23,944 @ ——
Grant
2024-06-13
GRANADILLO PEDRO P
Director
23,944 @ ——
Grant
2024-06-13
GRANADILLO PEDRO P
Director
4,655 @ $15.04$70K
Grant
2024-06-13
Bjork Elisabeth
Director
23,944 @ ——
Grant
2024-06-13
Malik Fady Ibraham
Director
23,944 @ ——
Grant
2024-06-13
BOESS CARSTEN
Director
23,944 @ ——
Grant
2024-06-13
WONG RODERICK
Director
23,944 @ ——
Grant
2024-06-13
WONG RODERICK
Director
3,325 @ $15.04$50K
Grant
2024-06-13
Makker Gotham
Director
23,944 @ ——
Grant
2024-06-13
Makker Gotham
Director
2,660 @ $15.04$40K
Grant
2024-06-13
SOUTHWELL DAVID P
Director
23,944 @ ——
Sell
2024-05-17
Schwartz Jonathan David
See Remarks
2,754 @ $23.35$64K
Sell
2024-05-16
Militello John
See Remarks
1,079 @ $23.35$25K
Sell
2024-05-16
Shah Gaurav
CEO
9,790 @ $23.35$229K
Sell
2024-05-16
Wilson Martin
General Counsel
1,048 @ $23.35$24K
Sell
2024-05-16
Patel Kinnari
See Remarks
4,046 @ $23.35$94K
Exercise
2024-05-14
Patel Kinnari
See Remarks
5,533 @ ——
Exercise
2024-05-14
Patel Kinnari
See Remarks
3,990 @ ——
Exercise
2024-05-14
Wilson Martin
General Counsel
2,420 @ ——
Exercise
2024-05-14
Shah Gaurav
CEO
7,979 @ ——
Exercise
2024-05-14
Shah Gaurav
CEO
9,683 @ ——
Exercise
2024-05-14
Patel Kinnari
See Remarks
5,553 @ ——
Gift
2024-05-02
SOUTHWELL DAVID P
Director
59,716 @ ——
Gift
2024-05-02
SOUTHWELL DAVID P
Director
113,124 @ ——
Sell
2024-04-22
Militello John
See Remarks
833 @ $22.87$19K
Sell
2024-04-15
SOUTHWELL DAVID P
Director
10,000 @ $24.05$241K
Exercise
2024-04-15
SOUTHWELL DAVID P
Director
29,624 @ $4.34$129K
Sell
2024-04-12
SOUTHWELL DAVID P
Director
59,716 @ $24.22$1.45M
Exercise
2024-04-12
SOUTHWELL DAVID P
Director
70,000 @ $4.34$304K
Sell
2024-04-12
SOUTHWELL DAVID P
Director
10,284 @ $25.16$259K
Sell
2024-04-08
White Mark Andrew
See Remarks
12,532 @ $24.64$309K
Grant
2024-04-01
Ondrey Aaron
Chief Financial Officer
46,781 @ ——
Grant
2024-04-01
Ondrey Aaron
Chief Financial Officer
69,337 @ ——
← All catalysts for $RCKT