Yeji
NDA/BLA filedoutcome: unknownconf 0.95

et-600 — NDA/BLA filed

$ETON · Eton Pharmaceuticals, Inc.
Event date
July 8, 2025
333 days ago
Sponsor runway
cash-flow +
$19.7M liquid

Evidence

the Company's New Drug Application for ET-600, a proprietary patented formulation of desmopressin oral solution, was accepted for review by the Food and Drug Administration (FDA) and assigned a Prescription Drug User Fee Administration target action date of February 25, 2026.
Source: 8-K filed 2025-07-08View on EDGAR ↗0001437749-25-022298

Comparable historical nda/bla fileds· last 5 years · same event type

TickerDrugDateOutcome
$AXSM2025-12-31unknown
$RCKTkresladi2025-10-14unknown
$ALDXreproxalap2025-07-17unknown
$BCRXorladeyo (berotralstat)2025-05-14unknown
$CORTrelacorilant2025-03-03unknown
$ALDXreproxalap2024-11-01unknown
$AXSMaxs-072024-09-04unknown
$RCKTkresladi2023-10-02unknown
$GERNimetelstat2023-08-21unknown
$CRMDdefencath2023-06-21unknown

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