Ardelyx Inc.
34175 Ardenwood Boulevard
Suite 100
Fremont
California
94555
United States
Tel: 510-745-1700
Website: http://www.ardelyx.com/
263 articles about Ardelyx Inc.
-
Ardelyx Launching IBSRELA® Second Quarter of 2022
11/30/2021
Ardelyx, Inc. today announced plans to launch IBSRELA, the company's approved treatment for irritable bowel syndrome with constipation (IBS-C) in adults, in the second quarter of 2022.
-
Ardelyx Reports Third Quarter 2021 Financial Results
11/12/2021
Ardelyx, Inc., a biopharmaceutical company focused on the discovery, development, and commercialization of innovative first-in-class medicines to improve treatment for people with kidney and cardiorenal diseases, reported business events and financial results for the third quarter ended September 30, 2021.
-
Ardelyx to Present at the 2021 Jefferies London Healthcare Conference
11/11/2021
Ardelyx, Inc., a biopharmaceutical company focused on the discovery, development, and commercialization of innovative first-in-class medicines to improve treatment for people with kidney and cardiorenal diseases, announced that Mike Raab, president and chief executive officer of Ardelyx, will participate in a fireside chat at the Jefferies London Healthcare Conference, which is taking place virtually and in-person on November 16 – 19, 2021.
-
Ardelyx Reports Additional Positive Data Supporting Clinical Utility of Tenapanor at ASN's Kidney Week 2021
11/5/2021
Ardelyx, Inc. today announced multiple presentations covering additional positive clinical observations with tenapanor at the American Society of Nephrology Kidney Week 2021 (ASN Kidney Week), which is taking place virtually November 4 - November 7, 2021.
-
Ardelyx, Inc. is lacing up the gloves and preparing to wade into the ring with the U.S. Food and Drug Administration to dispute the July rejection of its chronic kidney disease drug, tenapanor.
-
Ardelyx Announces Four Tenapanor Presentations at ASN's Kidney Week 2021
10/29/2021
Ardelyx, Inc.today announced that four tenapanor abstracts have been accepted for presentation at the American Society of Nephrology Kidney Week 2021 (ASN Kidney Week), which is taking place virtually November 4 - November 7, 2021.
-
The FDA gave Ardelyx a CRL on the NDA but did not mention anything about clinical pharmacology or biopharmaceutics, safety, or any related non-clinical concerns.
-
Ardelyx Provides Corporate Update Following Type A Meeting with FDA
10/13/2021
Ardelyx, Inc. today announced that the company has met with the U.S. Food and Drug Administration (FDA) in a Type A meeting
-
Ardelyx Announces Publication of 52-Week Phase 3 PHREEDOM Trial
9/3/2021
Ardelyx, Inc. (Nasdaq: ARDX), today announced the publication of the company's long term 52-week Phase 3 PHREEDOM trial in the American Society of Nephrology journal, Kidney360.
-
Ardelyx Reports Second Quarter 2021 Financial Results
8/13/2021
Ardelyx, Inc. today reported business events and financial results for the second quarter ended June 30, 2021.
-
Ardelyx indicates the restructuring plan will save $17 million in annual cash compensation although there will be a restructuring charge of about $3.4 million.
-
Shares of Ardelyx, Inc. have fallen nearly 13% in premarket trading after the U.S. FDA rejected the company's chronic kidney disease drug, tenapanor.
-
Ardelyx Receives Complete Response Letter from U.S. FDA for New Drug Application for Tenapanor for the Control of Serum Phosphorus in Adult Patients with CKD on Dialysis
7/29/2021
Ardelyx, Inc. (Nasdaq: ARDX), today announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the company's New Drug Application (NDA) for tenapanor for the control of serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis.
-
The U.S. Food and Drug Administration (FDA) had several PDUFA dates on their calendar for the last week of July, but in two cases, there were problems with the submissions ahead of time. Here’s a look.
-
The FDA said it found an issue with the "size of the treatment effect and clinical relevance" of Ardelyx's new drug tenapanor without providing additional details.
-
Ardelyx Provides Regulatory Update on New Drug Application for Tenapanor for the Control of Serum Phosphorus in Adult Patients with CKD on Dialysis
7/19/2021
Ardelyx, Inc. today announced that it received a letter from the U.S. Food and Drug Administration on July 13, 2021, stating that, as part of its ongoing review of the company's New Drug Application ("NDA") for the control of serum phosphorus in adult patients with chronic kidney disease ("CKD") on dialysis, the FDA has identified deficiencies that preclude discussion of labeling and post-marketing requirements/commitments at this time.
-
Ardelyx Announces Presentations at ERA-EDTA Virtual Congress 2021
6/7/2021
Ardelyx, Inc. (Nasdaq: ARDX), today announced two presentations highlighting new tenapanor data at the European Renal Association – European Dialysis and Transplant Association (ERA-EDTA) Virtual Congress 2021
-
Ardelyx to Present at the Jefferies 2021 Virtual Healthcare Conference
5/25/2021
Ardelyx, Inc., a biopharmaceutical company focused on developing innovative first-in-class medicines to improve treatment for people with kidney and cardiorenal diseases, announced that Mike Raab, president and chief executive officer of Ardelyx, will participate in a fireside chat at the Jefferies Virtual Healthcare Conference on Tuesday, June 1, 2021 at 3:30 p.m. ET.
-
Ardelyx Reports First Quarter 2021 Financial Results and Recent Business Highlights
5/6/2021
Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company focused on developing innovative first-in-class medicines to improve treatment for people with kidney and cardiorenal diseases, today reported business highlights and financial results for the first quarter ended March 31, 2021 .
-
Ardelyx Announces Extension of the PDUFA Review Period for Tenapanor for the Control of Serum Phosphorus in Adult Patients with CKD on Dialysis
4/29/2021
Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company focused on the discovery, development, and commercialization of innovative first-in-class medicines to improve treatment for people with kidney and cardiorenal diseases, today announced that the Prescription Drug User Fee Act (PDUFA)