Yeji
FDA approvaloutcome: successconf 1.00

khindivi — FDA approval

$ETON · Eton Pharmaceuticals, Inc.
Event date
May 28, 2025
374 days ago
Sponsor runway
cash-flow +
$19.7M liquid

Evidence

openFDA ORIG (TYPE 3) approval of KHINDIVI — application NDA218980

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

4 insiders · 2 buys · 10 sells
Sell
2025-08-20
Gruber James R.
Chief Financial Officer
2,631 @ $16.02$42K
Sell
2025-08-19
Gruber James R.
Chief Financial Officer
39,082 @ $16.16$632K
Sell
2025-06-16
Krempa David
Chief Business Officer
10,223 @ $14.73$151K
Sell
2025-06-13
Krempa David
Chief Business Officer
6,800 @ $14.77$100K
Sell
2025-06-12
Krempa David
Chief Business Officer
16,977 @ $14.92$253K
Buy
2025-06-10
Opaleye Management Inc.
10%+ Owner
2,930 @ $15.82$46K
Buy
2025-06-10
Opaleye Management Inc.
10%+ Owner
5,000 @ $15.82$79K
Sell
2025-06-05
BRYNJELSEN SEAN
President & CEO
70,000 @ $16.81$1.18M
Sell
2025-06-04
BRYNJELSEN SEAN
President & CEO
70,000 @ $17.00$1.19M
Sell
2025-06-03
BRYNJELSEN SEAN
President & CEO
8,655 @ $18.38$159K
Sell
2025-06-03
BRYNJELSEN SEAN
President & CEO
60,945 @ $17.38$1.06M
Sell
2025-06-03
BRYNJELSEN SEAN
President & CEO
400 @ $19.02$8K