Yeji
FDA approvaloutcome: successconf 1.00

nitisinone — FDA approval

$ETON · Eton Pharmaceuticals, Inc.
Event date
May 25, 2023
1108 days ago
Sponsor runway
cash-flow +
$19.7M liquid

Evidence

openFDA ORIG (UNKNOWN) approval of NITISINONE — application ANDA216201

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

6 insiders · 0 buys · 0 sells
Grant
2023-03-03
Gruber James R.
Chief Financial Officer
100,086 @
Grant
2023-03-03
CASAMENTO CHARLES J
Director
25,000 @
Grant
2023-03-03
Adams Jennifer McKie
Director
25,000 @
Grant
2023-03-03
MAIER PAUL V
Director
25,000 @
Grant
2023-03-03
BRYNJELSEN SEAN
President & CEO
350,381 @
Grant
2023-03-03
RIEDEL NORBERT G
Director
25,000 @