Ardelyx Inc.

262 articles about Ardelyx Inc.

• Ardelyx Announces FDA Acceptance and Six-Month Review for Resubmission of its New Drug Application of XPHOZAH® (tenapanor)User Fee Goal Date: October 17, 2023

  5/17/2023

  Ardelyx, Inc. today announced that the U.S. Food and Drug Administration (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.

• Ardelyx, Inc. Reports Employment Inducement Grants - May 15, 2023

  5/15/2023

  Ardelyx, Inc. announced that on May 8, 2023, the compensation committee of the company’s board of directors granted two new non-executive employees options to purchase an aggregate of 46,178 shares of the company’s common stock, and granted five new non-executive employees an aggregate of 52,600 Restricted Stock Units.

• Ardelyx Presents Positive Data at DDW 2023 on IBSRELA® (tenapanor), a First-In-Class Treatment for IBS-C in Adults

  5/9/2023

  Ardelyx, Inc. (Nasdaq: ARDX) today announced that a new analysis from IBSRELA Phase 3 trial, T3MPO-2, was presented in a poster presentation at the 2023 Digestive Disease Week Conference (DDW 2023) that is now underway in Chicago, Illinois.

• Ardelyx Reports First Quarter 2023 Financial Results and Provides Business Update

  5/3/2023

  Ardelyx, Inc., a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs, reported financial results for the first quarter ended March 31, 2023 and provided a business update.

• Ardelyx Announces Additional Data Supporting First-In-Class IBSRELA® (tenapanor) for Adults with IBS-C, to be Presented at the 2023 Digestive Disease Week Conference

  5/1/2023

  Ardelyx, Inc. announced that additional data supporting the efficacy and safety of IBSRELA will be presented in a poster at the 2023 Digestive Disease Week Conference to be held May 6-9, 2023, in Chicago, Illinois.

• Ardelyx to Report First Quarter 2023 Financial Results and Provide Business Update on May 3, 2023

  4/26/2023

  Ardelyx, Inc. announced it will hold a conference call on Wednesday, May 3, 2023, at 4:30 p.m. Eastern Time to discuss first quarter financial results and provide a business update.

• Ardelyx Resubmits New Drug Application to U.S. Food and Drug Administration for XPHOZAH® (tenapanor)Company expects to receive goal review date in mid-May

  4/18/2023

  Ardelyx, Inc. (Nasdaq: ARDX) today announced the resubmission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the approval of 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.

• Ardelyx, Inc. Reports Employment Inducement Grants - April 13, 2023

  4/13/2023

  Ardelyx, Inc. announced that on April 10, 2023, the compensation committee of the company’s board of directors granted three new non-executive employees options to purchase an aggregate of 238,426 shares of the company’s common stock, and granted four new non-executive employees an aggregate of 89,250 Restricted Stock Units.

• Ardelyx Presents Positive Data Further Supporting Efficacy and Safety of XPHOZAH® (tenapanor) at National Kidney Foundation 2023 Spring Clinical Meetings

  4/12/2023

  Ardelyx, Inc. (Nasdaq: ARDX) today announced multiple presentations covering additional positive clinical observations of XPHOZAH at the National Kidney Foundation (NKF) 2023 Spring Clinical Meetings, which is taking place in Austin, TX from April 11-15, 2023.

• Ardelyx Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Business Update

  3/2/2023

  Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs, today reported financial results for the fourth quarter and full year ended December 31, 2022 and provided a business update.

• Ardelyx to Participate at the Cowen 43rd Annual Health Care Conference

  2/27/2023

  Ardelyx, Inc. today announced that Mike Raab, president and chief executive officer of Ardelyx, will participate in a GI/Microbiome panel discussion at the Cowen 43rd Annual Health Care Conference on Monday March 6, 2023 at 9:10 A.M. Eastern Time in Boston, MA.

• Ardelyx to Report Fourth Quarter and Full Year 2022 Financial Results and Provide Business Update on March 2, 2023Conference call scheduled for 4:30 p.m. Eastern Time

  2/23/2023

  Ardelyx, Inc. today announced it will hold a conference call on Thursday, March 2, 2023, at 4:30 p.m. Eastern Time to discuss fourth quarter and full year 2022 financial results and provide a business update.

• Ardelyx, Inc. Reports Employment Inducement Grants - February 02, 2023

  2/2/2023

  Ardelyx, Inc. announced that on January 27, 2023, the compensation committee of the company's board of directors granted 23 new non-executive employees options to purchase an aggregate of 614,064 shares of the company's common stock, and an aggregate of 236,333 Restricted Stock Units.

• FDA Grants Appeal for Ardelyx's XPHOZAH® (tenapanor)

  12/29/2022

  Ardelyx, Inc. announced that the Office of New Drugs, Center for Drug Evaluation and Research of the U.S. Food and Drug Administration granted the appeal to the Complete Response Letter for the New Drug Application for XPHOZAH.

• Ardelyx, Inc. Reports Employment Inducement Grants - December 23, 2022

  12/23/2022

  Ardelyx, Inc. announced that on December 16, 2022, the compensation committee of the company's board of directors granted 17 new non-executive employees options to purchase an aggregate of 271,735 shares of the company's common stock, and an aggregate of 123,375 Restricted Stock Units.

• Ardelyx Provides Update on FDA Appeal for XPHOZAH® (tenapanor) for the Control of Serum Phosphorus in Adult Patients with Chronic Kidney Disease on Dialysis

  12/17/2022

  Ardelyx, Inc., a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative first-in-class medicines that meet significant unmet medical needs, provided an update regarding the appeal to the Complete Response Letter for the New Drug Application for XPHOZAH.

• Ardelyx to Present at the 34th Annual Piper Sandler Healthcare Conference

  11/22/2022

  Ardelyx, Inc. today announced that management will participate in a fireside discussion at the 34th Annual Piper Sandler Healthcare Conference.

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  Ardelyx’s CKD Drug Clears FDA Adcomm Hurdle with 9-4 Vote

  11/17/2022

  Ardelyx has moved one step closer to the possible approval of its experimental chronic kidney disease drug tenapanor following a favorable 9-4 vote from an FDA advisory committee.

• Ardelyx Announces FDA Advisory Committee Votes that the Benefits of XPHOZAH® (tenapanor) Outweigh its Risks for the Control of Serum Phosphorus in Adult Patients with Chronic Kidney Disease on Dialysis

  11/16/2022

  Ardelyx, Inc. (Nasdaq: ARDX) today announced the vote of the U.S. Food and Drug Administration's (FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC) meeting for XPHOZAH for the control of serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis.

• Ardelyx Stock Trading Halted Today; FDA Advisory Committee to Discuss XPHOZAH® (tenapanor) for the Control of Serum Phosphorus in Adult Patients with Chronic Kidney Disease on Dialysis

  11/16/2022

  Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative first-in-class medicines that meet significant unmet medical needs, today announced that Nasdaq has halted trading of the Company's common stock.