Yeji

$CRMD

CorMedix Inc.

Runway:cash-flow +
NasdaqMarket cap: —CIK 0001410098

Upcoming catalysts

3 surfaced
NDA/BLA filedDate TBD~ low confidence
$CRMDCorMedix Inc.
defencath
“the New Drug Application for DefenCath was resubmitted to the U.S. Food and Drug Administration, and the submission has been acknowledged as received for processing.”
CRLDate TBD~ low confidence
$CRMDCorMedix Inc.
defencath
“resubmitted the New Drug Application for DefenCath to address the Complete Response Letter issued by the U.S. Food and Drug Administration a year ago”
FDA approvalDate TBD~ low confidence
$CRMDCorMedix Inc.
“Upon the issuance of the U.S. Food and Drug Administration ("FDA") marketing approval of (a) the product known as REZZAYO™ (rezafungin) as of the date hereof or as may be modified thereafter, or (b) any product that contains the active ingredient rezafungin, for the prevention or prophylaxis of invasive fungal infections in adult patients undergoing allogeneic stem cell blood and marrow transplant or the regulatory equivalent on or prior to June 30, 2029”

Drug pipeline

defencath
Taurolidine and Heparin
Catheter-related Bloodstream Infection
Neutrolin
Kidney Failure, Chronic
CRMD-001-Deferiprone
Contrast-Induced Acute Kidney Injury
(taurolidine and heparin) catheter lock solution
Catheter-Related Infections
deferiprone
Acute Kidney Injury

Recent & active trials

NCTDrugPhaseStatusPrimary completion
NCT06714864(taurolidine and heparin) catheter lock solutionPhase 4Recruiting2028-07-01
NCT06822426(taurolidine and heparin) catheter lock solutionPhase 3Recruiting2028-01-01
NCT02651428NeutrolinPhase 3Completed2018-10-01
NCT01391520deferipronePhase 3Withdrawn2013-03-01
NCT01146925CRMD-001-DeferipronePhase 2Completed2011-06-01
NCT06707480Taurolidine and Heparin—Available—

Recent catalysts

FDA approvalNov 15, 2023· 934d ago· success
$CRMDCorMedix Inc.
defencath
“openFDA ORIG (TYPE 1/4) approval of DEFENCATH — application NDA214520”
PDUFANov 15, 2023· 934d ago· success
$CRMDCorMedix Inc.
defencath
“the FDA considers the resubmission as a complete Class 2 response with a six-month review and has assigned a Prescription Drug User Fee Act target action date of November 15, 2023”
NDA/BLA filedJun 21, 2023· 1081d ago· unknown
$CRMDCorMedix Inc.
defencath
“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")”
CRLAug 8, 2022· 1398d ago
$CRMDCorMedix Inc.
defencath
“On August 8, 2022, CorMedix Inc. (the "Company") issued a press release announcing that a second Complete Response Letter was received from the U.S. Food and Drug Administration ("FDA"), stating that the New Drug Application ("NDA") for DefenCath cannot be approved until the deficiencies conveyed to the contract manufacturing organization and the supplier of the active pharmaceutical ingredient heparin during inspections are resolved to the satisfaction of FDA.”
NDA/BLA filedMar 28, 2022· 1531d ago· unknown
$CRMDCorMedix Inc.
defencath
“the resubmission of the New Drug Application for DefenCath has been accepted for filing by the U.S. Food and Drug Administration.”