Yeji

$ARDX

ARDELYX, INC.

Runway:3 mo
NasdaqMarket cap: —CIK 0001437402

Upcoming catalysts

1 surfaced
AdComDate TBD~ low confidence
$ARDXARDELYX, INC.
xphozah
“the OND intends to direct the Division of Cardiology and Nephrology to bring the XPHOZAH New Drug Application (NDA) to the Cardiovascular and Renal Drugs Advisory Committee, and to provide a response to the Company's appeal within thirty (30) days after the conclusion of the Advisory Committee meeting.”

Drug pipeline

xphozah
tenapanor
control of serum phosphorus in chronic kidney disease patients on dialysis
AZD1722
Constipation Predominant Irritable Bowel Syndrome
Tenapanor 5 mg BID
Chronic Idiopathic Constipation (CIC)
RDX227675
Hyperkalemia
AZD1722 salt tablet
Healthy Volunteers Food Interaction Study
Midazolam
Healthy Volunteers
RDX013
Hyperkalemia
Treatment A (cefadroxil alone)
Healthy Volunteers
Tenapanor 50 MG
Irritable Bowel Syndrome With Constipation (IBS-C)
RDX5791
Constipation Predominant Irritable Bowel Syndrome
AZD1722 (in-patient)
End Stage Renal Disease

Recent & active trials

NCTDrugPhaseStatusPrimary completion
NCT05905926tenapanorPhase 3Enrolling By Invitation2031-07-01
NCT07382167Tenapanor 5 mg BIDPhase 3Recruiting2027-02-26
NCT05643534Tenapanor 50 MGPhase 3Active Not Recruiting2026-09-01
NCT06553547tenapanorPhase 2Active Not Recruiting2026-07-01
NCT06203444tenapanorPhase 1Completed2024-05-30
NCT04780841RDX013Phase 2Completed2021-12-28
NCT04549597tenapanorPhase 4Completed2021-10-13
NCT03988920tenapanorPhase 4Completed2021-06-26
NCT03427125tenapanorPhase 3Completed2019-11-15
NCT03824587tenapanorPhase 3Completed2019-07-17
NCT02727751tenapanorPhase 3Completed2017-10-01
NCT02686138tenapanorPhase 3Completed2017-08-01
NCT03018067RDX227675Phase 2Terminated2017-05-01
NCT02621892tenapanorPhase 3Completed2017-03-01
NCT02675998tenapanorPhase 3Completed2016-12-01
NCT01847092AZD1722Phase 2Completed2015-03-01
NCT02081534AZD1722Phase 2Completed2014-11-01
NCT01923428AZD1722Phase 3Completed2014-10-01
NCT02140281Treatment A (cefadroxil alone)Phase 1Completed2014-08-01
NCT02140268MidazolamPhase 1Completed2014-08-01

Recent catalysts

FDA approvalOct 17, 2023· 963d ago· success
$ARDXARDELYX, INC.
xphozah
“openFDA ORIG (TYPE 10) approval of XPHOZAH 10 MG — application NDA213931”
PDUFAOct 17, 2023· 963d ago· success
$ARDXARDELYX, INC.
xphozah
“The FDA has set a user fee goal date of October 17, 2023.”
NDA/BLA filedMay 17, 2023· 1116d ago· unknown
$ARDXARDELYX, INC.
xphozah
“the U.S. Food and Drug Administration (the "FDA") has accepted its resubmission of a New Drug Application ("NDA") for XPHOZAH® (tenapanor) for the control of serum phosphate in adult patients with chronic kidney disease on dialysis who have had an inadequate response or intolerance to a phosphate binder therapy.”
PDUFAJul 29, 2021· 1773d ago· unknown
$ARDXARDELYX, INC.
“In April 2021, the FDA extended the PDUFA date for the NDA to July 29, 2021 as a result of the Company's submission of additional data analyses requested by the FDA.”
CRLJul 28, 2021· 1774d ago
$ARDXARDELYX, INC.
xphozah
“received an Appeal Granted Letter ("AGL") from the Office of New Drugs ("OND") ... granting the Company's appeal of the July 28, 2021 issuance of a Complete Response Letter ("CRL") for the Company's New Drug Application for XPHOZAH (tenapanor).”