Ardelyx Inc.

224 articles about Ardelyx Inc.

• 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)

• Ardelyx Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) - Apr 16, 2021

  4/16/2021

  Ardelyx, Inc. announced that on April 12, 2021, the compensation committee of the Company's Board of Directors granted a non-qualified stock option award to purchase 125,622 shares of its common stock and a restricted stock unit award for 26,315 shares in connection with the commencement of employment of its new Chief People Officer, Sarah O'Brien, under the Company's 2016 Employment Commencement Incentive Plan.

• Ardelyx Collaboration Partner, Kyowa Kirin, Announces Initiation of Phase 3 Clinical Studies of Tenapanor for Hyperphosphatemia in Japan

  4/14/2021

   Ardelyx, Inc. today announced that its collaboration partner in Japan, Kyowa Kirin Co., Ltd. (TSE: 4151, Kyowa Kirin), has initiated four Phase 3 clinical studies in Japan evaluating tenapanor for hyperphosphatemia.

• Ardelyx Announces Upcoming Data Presentation at ISN World Congress of Nephrology 2021

  4/12/2021

   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 announced that it will present a poster highlighting data from NORMALIZE, an ongoing Phase 4 trial

• 

  FDA Action Alert: Avenue, Merck, Sol-Gel, Protalix and Chiesi, and Ardelyx

  4/12/2021

  The U.S. Food and Drug Administration’s schedule for April has several PDUFA dates scattered across the rest of the month. Here’s a look.

• Ardelyx Announces Poster Presentations, Educational Symposium, and Exhibitor Showcase at National Kidney Foundation 2021 Virtual Spring Clinical Meetings

  3/30/2021

   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 announced that it will present two posters at the National Kidney Foundation 2021 Spring Clinical Meeting (NKF SCM2021), which will take place virtually April 6-10, 2021.

• Ardelyx Appoints Muna Bhanji, R.Ph, to its Board of Directors

  3/15/2021

  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 announced the appointment of Muna Bhanji, R.Ph, to the company's board of directors, effective March 11, 2021.

• Ardelyx to Present at the 10th Annual SVB Leerink Global Healthcare Conference

  2/17/2021

   Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company focused on developing innovative first-in-class medicines to improve treatment for people with kidney and cardiovascular diseases, today announced that Mike Raab , president and chief executive officer of Ardelyx, will participate in a fireside chat at the 10 th Annual SVB Leenik Global Healthcare Conference

• Ardelyx to Present at the Piper Sandler 32nd Annual Virtual Healthcare Conference

  11/23/2020

  Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company focused on developing innovative first-in-class medicines to improve treatment for people with kidney and cardiovascular diseases, today announced that a webcast of Mike Raab , president and chief executive officer of Ardelyx, and Susan Rodriguez , chief commercial offic

• Ardelyx to Present at the Jefferies Virtual London Healthcare Conference

  11/10/2020

  Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company focused on developing innovative first-in-class medicines to improve treatment for people with kidney and cardiovascular diseases, today announced that Mike Raab , president and chief executive officer of Ardelyx, will participate in a fireside chat at the Jefferies Virtu

• Ardelyx to Webcast Virtual Analyst Day

  11/6/2020

  Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company focused on developing first-in-class medicines to improve treatment for people with kidney and cardiovascular diseases, today announced that it will hold a virtual Analyst Day on Thursday, November 12, 2020, from 9:30 a.m. to 12:00 p.m. ET.

• Ardelyx Reports Third Quarter 2020 Financial Results and Business Highlights

  11/5/2020

  Ardelyx Inc.  (Nasdaq: ARDX), a specialized biopharmaceutical company focused on developing innovative first-in-class medicines to improve treatment for people with kidney and cardiovascular diseases, today reported business highlights and financial results for the third quarter ended September 30, 2020.

• Ardelyx Launches 'Can We Do Better?' Campaign at ASN's Kidney Week 2020

  10/22/2020

  --Campaign highlights Ardelyx commitment to advance the science of phosphate absorption to address significant unmet needs in the current treatment of hyperphosphatemia--

• Ardelyx Announces Data Supporting Efficacy and Safety of Tenapanor, a First-in-Class Phosphate Absorption Inhibitor, to be Presented at ASN's Kidney Week 2020

  10/12/2020

  Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company focused on developing first-in-class medicines to improve treatment for people with kidney and cardiovascular diseases

• Ardelyx Announces FDA Acceptance for Filing of its New Drug Application of Tenapanor for the Control of Serum Phosphorus in Adult Patients with CKD on Dialysis

  9/15/2020

  NDA Supported by Data from Expansive Clinical Development Program Demonstrating Tenapanor's use as Foundational Therapy PDUFA Goal Date - April 29, 2021   [15-September-2020]   FREMONT, Calif. , Sept. 15, 2020 /PRNewswire/ -- Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company focused on developing first-in-class medicines to improve treatment for people w

• Ardelyx to Participate in Three Upcoming Investor Conferences in September

  9/8/2020

  Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company focused on developing first-in-class medicines to improve treatment for people with kidney and cardiovascular diseases, today announced that Ardelyx management will participate in three upcoming investor conferences in September including:

• Ardelyx Reports Second Quarter 2020 Financial Results and Recent Business Highlights

  8/6/2020

  Submitted a New Drug Application to the U.S. Food and Drug Administration for the review of tenapanor as a first-in-class therapy to control serum phosphorus in adult patients with chronic kidney disease on dialysis Maintains strong balance sheet with $204.8 million in cash, cash equivalents and short-term investments

• Ardelyx Selected as a Finalist in the Fierce Innovation Awards for the Development of its First-in-Class Product Candidate Tenapanor

  8/3/2020

  A New Drug Application for the Review of Tenapanor to Control Serum Phosphorus in Adult Patients with Chronic Kidney Disease on Dialysis has Been Submitted to the FDA

• Ardelyx Announces Submission of New Drug Application to the U.S. FDA for Tenapanor for the Control of Serum Phosphorus in Adult Patients with CKD on Dialysis

  6/30/2020

  Application is Supported by Three Positive Phase 3 Clinical Trials for Tenapanor for Hyperphosphatemia, a Condition which affects Approximately 85% of CKD Patients on Dialysis

• Ardelyx Announces Positive Second Data Analysis from Ongoing NORMALIZE Phase 4 Study Evaluating Tenapanor in CKD Patients on Dialysis

  6/15/2020

  Foundational use of tenapanor as monotherapy or with sevelamer enabled up to 47.4% of patients to achieve normal serum phosphorus levels (<4.6 mg/dL), a 58% improvement over current standard of care NDA submission for tenapanor for the control of serum phosphorus on-track for mid-2020 Separately, Ardelyx's tenapanor partner in Japan, Kyowa Kirin, presented Phase 2 data at ERA-EDTA demonstrating tenapanor enabled a significant reduction in overall pill burden (mean reductio