Yeji
FDA approvaloutcome: successconf 1.00

ibtrozi — FDA approval

$NUVB · Nuvation Bio Inc.
Event date
June 11, 2025
360 days ago
Sponsor runway
cash-flow +
$533.7M liquid

Evidence

openFDA ORIG (TYPE 1) approval of IBTROZI — application NDA219713

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

100% hit rate (10/10)
TickerDrugDateOutcome
$INCYzynyz2026-05-18success
$INCYjakafi xr2026-05-01success
$AXSMauvelity2026-04-30success
$INCYzynyz2026-03-30success
$BIIBspinraza2026-03-27success
$CORTlifyorli2026-03-25success
$RYTMimcivree2026-03-19success
$ASNDyuviwel2026-02-27success
$BMRNpalynziq2026-02-27success
$ETONdesmoda2026-02-25success

Recent insider activity· ±90 days

11 insiders · 11 buys · 1 sells
Gift
2025-08-11
Mashal Robert
Director
350,001 @
Buy
2025-06-18
Markel Stacy
CHIEF PEOPLE OFFICER
10,000 @ $1.71$17K
Buy
2025-06-17
Sauvage Philippe
Chief Financial Officer
4,000 @ $1.79$7K
Buy
2025-06-16
Sauvage Philippe
Chief Financial Officer
3,300 @ $1.83$6K
Buy
2025-06-16
Wentworth Kerry
CHIEF REGULATORY OFFICER
26,000 @ $1.79$47K
Buy
2025-06-16
Wentworth Kerry
CHIEF REGULATORY OFFICER
24,000 @ $1.80$43K
Buy
2025-06-16
Hung David
PRESIDENT AND CEO
500,000 @ $1.79$894K
Buy
2025-06-16
Sjogren Colleen
Chief Commercial Officer
50,000 @ $1.81$90K
Grant
2025-05-21
Bazemore Robert B
Director
292,983 @
Grant
2025-05-21
VERNON W ANTHONY
Director
292,983 @
Grant
2025-05-21
BLICKENSTAFF KIM D
Director
292,983 @
Grant
2025-05-21
FALBERG KATHRYN E
Director
292,983 @
Grant
2025-05-21
Mashal Robert
Director
292,983 @
Sell10b5-1
2025-05-02
Liu Dongfang
CHIEF MEDICAL OFFICER
20,000 @ $2.50$50K
Exercise10b5-1
2025-05-02
Liu Dongfang
CHIEF MEDICAL OFFICER
20,000 @ $1.94$39K
Buy
2025-04-07
Hung David
PRESIDENT AND CEO
300,000 @ $1.63$488K
Buy
2025-04-04
Hung David
PRESIDENT AND CEO
200,000 @ $1.66$333K
Buy
2025-04-01
Mashal Robert
Director
98,900 @ $1.67$165K
Buy
2025-04-01
Mashal Robert
Director
1,100 @ $1.67$2K