Yeji
NDA/BLA filedoutcome: unknownconf 0.95

defencath — NDA/BLA filed

$CRMD · CorMedix Inc.
Event date
June 21, 2023
1081 days ago
Sponsor runway
cash-flow +
$178.1M liquid

Evidence

“the resubmission of the New Drug Application ("NDA") for DefenCath has been accepted for filing by the U.S. Food and Drug Administration (the "FDA")”
Source: 8-K filed 2023-06-21View on EDGAR ↗0001213900-23-050240

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

TickerDrugDateOutcome
$AXSM—2025-12-31unknown
$RCKTkresladi2025-10-14unknown
$ALDXreproxalap2025-07-17unknown
$ETONet-6002025-07-08unknown
$BCRXorladeyo (berotralstat)2025-05-14unknown
$CORTrelacorilant2025-03-03unknown
$ALDXreproxalap2024-11-01unknown
$AXSMaxs-072024-09-04unknown
$RCKTkresladi2023-10-02unknown
$GERNimetelstat2023-08-21unknown

Recent insider activity· ±90 days

5 insiders · 2 buys · 0 sells
Buy
2023-09-08
Todisco Joseph
Chief Executive Officer
10,000 @ $3.71$37K
Buy
2023-05-18
Kaplan Myron
Director
6,000 @ $4.54$27K
Grant
2023-05-17
Stewart Robert A
Director
10,000 @ $4.37$44K
Grant
2023-05-17
Costa Paulo F
Director
10,000 @ $4.65$47K
Grant
2023-05-17
DUNTON ALAN W
Director
3,000 @ $4.33$13K
Grant
2023-05-17
Todisco Joseph
Chief Executive Officer
5,000 @ $4.58$23K
Tax10b5-1
2023-05-10
Todisco Joseph
Chief Executive Officer
37,443 @ $5.30$198K
Grant
2023-04-13
Stewart Robert A
Director
25,000 @ ——
Grant
2023-04-13
Stewart Robert A
Director
14,200 @ ——
← All catalysts for $CRMD