Yeji
PDUFAoutcome: unknownconf 0.99

et-400 — PDUFA

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

Evidence

“the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date for the New Drug Application (NDA) for ET-400. The new PDUFA goal date is May 28, 2025.”
Source: 8-K filed 2025-02-06View on EDGAR ↗0001437749-25-002935

Comparable historical pdufas· last 5 years · same event type

60% hit rate (3/5)
TickerDrugDateOutcome
$RCKTkresladi2026-03-28success
$RYTMimcivree2026-03-20success
$CYTKaficamten2025-12-26unknown
$ALDXreproxalap2025-12-16unknown
$BCRXorladeyo2025-12-12success
$OMERnarsoplimab2025-09-25unknown
$BCRXorladeyo (berotralstat)2025-09-12unknown
$ALDXreproxalap2025-04-02failure
$IONSolezarsen2024-12-19unknown
$RCKTkresladi2024-06-30failure

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
← All catalysts for $ETON