Yeji
PDUFAoutcome: unknownconf 0.90

topiramate — PDUFA

$ETON · Eton Pharmaceuticals, Inc.
Event date
November 6, 2021
1673 days ago
Sponsor runway
cash-flow +
$19.7M liquid

Evidence

The new PDUFA user fee goal date is November 6, 2021. Eton expects the FDA to announce a decision on or before this new PDUFA date.
Source: 8-K filed 2021-08-06View on EDGAR ↗0001493152-21-018932

Comparable historical pdufas· last 5 years · same event type

75% hit rate (3/4)
TickerDrugDateOutcome
$RCKTkresladi2026-03-28success
$RYTMimcivree2026-03-20success
$CYTKaficamten2025-12-26unknown
$ALDXreproxalap2025-12-16unknown
$BCRXorladeyo2025-12-12success
$OMERnarsoplimab2025-09-25unknown
$BCRXorladeyo (berotralstat)2025-09-12unknown
$ETONet-4002025-05-28unknown
$ALDXreproxalap2025-04-02failure
$IONSolezarsen2024-12-19unknown

Recent insider activity· ±90 days

3 insiders · 2 buys · 19 sells
Sell
2021-11-17
Opaleye Management Inc.
10%+ Owner
25,000 @ $4.67$117K
Sell
2021-11-16
Opaleye Management Inc.
10%+ Owner
11,500 @ $4.86$56K
Sell
2021-11-16
Opaleye Management Inc.
10%+ Owner
938 @ $4.86$5K
Sell
2021-11-15
Opaleye Management Inc.
10%+ Owner
2,500 @ $4.80$12K
Sell
2021-11-15
Opaleye Management Inc.
10%+ Owner
500 @ $4.80$2K
Sell
2021-11-08
Opaleye Management Inc.
10%+ Owner
2,661 @ $6.10$16K
Sell
2021-11-08
Opaleye Management Inc.
10%+ Owner
50,000 @ $6.10$305K
Sell
2021-11-05
Opaleye Management Inc.
10%+ Owner
159,300 @ $6.30$1.00M
Sell
2021-11-05
Opaleye Management Inc.
10%+ Owner
8,401 @ $6.30$53K
Sell
2021-11-04
Opaleye Management Inc.
10%+ Owner
81,700 @ $6.44$526K
Sell
2021-11-04
Opaleye Management Inc.
10%+ Owner
4,000 @ $6.44$26K
Sell
2021-11-03
Opaleye Management Inc.
10%+ Owner
110,000 @ $6.53$718K
Sell
2021-11-03
Opaleye Management Inc.
10%+ Owner
6,500 @ $6.53$42K
Sell
2021-10-12
Opaleye Management Inc.
10%+ Owner
82,500 @ $5.06$417K
Sell
2021-10-12
Opaleye Management Inc.
10%+ Owner
4,807 @ $5.06$24K
Sell
2021-10-11
Opaleye Management Inc.
10%+ Owner
32,500 @ $5.01$163K
Sell
2021-10-11
Opaleye Management Inc.
10%+ Owner
1,601 @ $5.01$8K
Sell
2021-10-08
Opaleye Management Inc.
10%+ Owner
41,000 @ $5.00$205K
Sell
2021-10-08
Opaleye Management Inc.
10%+ Owner
2,692 @ $5.00$13K
Buy
2021-08-20
Troutman William Wilson
CFO and Secretary
5,000 @ $4.43$22K
Buy
2021-08-20
BRYNJELSEN SEAN
President & CEO
10,000 @ $4.32$43K