Ardelyx, Inc., a specialized biopharmaceutical company, develops and sells disruptive medicines for the treatment of cardio renal and gastrointestinal diseases in the United States and Asia Pacific. The company’s lead product candidate is tenapanor, which has completed Phase III clinical trial for the treatment of patients with irritable bowel syndrome with constipation, as well as in Phase III clinical trial for the treatment of hyperphosphatemia in end-stage renal disease patients on dialysis. It also develops RDX013, a small molecule potassium secretagogue program for the treatment of patients with hyperkalemia; RDX8940, an oral TGR5 agonist; RDX011, a NHE3 inhibitor; and RDX023 program f...
34175 Ardenwood Boulevard
Fremont, CA 94555
Founded in 2007
Ardelyx, Inc. Announces License Agreement with Knight Therapeutics, Inc. to Provides Knight with Exclusive Rights to Commercialize Tenapanor in Canada
Mar 19 18
Ardelyx, Inc. announced a license agreement with Knight Therapeutics, Inc. that provides Knight with exclusive rights to commercialize tenapanor in Canada. Tenapanor is Ardelyx's oral, first-in-class small molecule treatment that has completed Phase 3 development for irritable bowel syndrome with constipation (IBS-C) and is being evaluated in a second Phase 3 study for hyperphosphatemia. Under the terms of the agreement, Ardelyx is eligible to receive up to CAD 25 million in total payments including an upfront payment and development and sales milestones, as well as double-digit tiered royalties on net sales. Knight will have the exclusive rights to market and sell tenapanor in Canada.
Ardelyx, Inc. Presents at DCAT Week 2018, Mar-19-2018
Mar 16 18
Ardelyx, Inc. Presents at DCAT Week 2018, Mar-19-2018 . Venue: New York, New York, United States. Speakers: James Kanter.
Ardelyx, Inc. Announces Unaudited Consolidated Earnings Results for the Fourth Quarter and Full Year Ended Dec. 31, 2017; Provides Pipeline Updates
Mar 14 18
Ardelyx, Inc. announced unaudited consolidated earnings results for the fourth quarter and full year ended Dec. 31, 2017. For the quarter, the company reported licensing revenue of $42,000,000. Income from operations $10,962,000 compared to loss of $31,476,000 a year ago. Net income of $10,114,000 or $0.21 per basic and diluted share compared to loss of $31,276,000 or $0.66 per basic and diluted share a year ago.
For the year, the company reported licensing revenue of $42,000,000. Loss from operations $65,115,000 compared to $112,895,000 a year ago. Net loss of $64,339,000 or $1.36 per basic and diluted share compared to $112,387,000 or $2.80 per basic and diluted share a year ago.
Ardelyx, Inc. provided pipeline updates. Second Phase 3 Clinical Trial of Tenapanor for Hyperphosphatemia Underway: In February 2018, Ardelyx began treating patients in the Phreedom Trial, the company's second Phase 3 clinical trial of tenapanor for the treatment of hyperphosphatemia in patients with end-stage renal disease who are on dialysis. This clinical trial includes a 26-week open-label treatment period, with a 12-week placebo-controlled randomized withdrawal period followed by an additional 14-week safety extension period for a total of up to 52 weeks. An active control group, for safety analysis only and consistent with other Phase 3 registration studies for hyperphosphatemia, will receive sevelamer carbonate, open-label, for the entire 52-week study period. Topline data from this clinical trial are currently anticipated in 2019. Expanding Renal Pipeline with RDX013 Program: Ardelyx is leveraging its expertise in renal drug development to advance its early-stage RDX013 program for the potential treatment of hyperkalemia. RDX013 is a novel, small molecule program that Ardelyx believes may work by tapping into the gastrointestinal tract's natural ability to secrete potassium into the lumen of the gut to reduce serum potassium levels. This mechanism differs significantly from the potassium binders currently on or approaching the market, and, like tenapanor for hyperphosphatemia, has the potential to provide the first non-binder approach to treat hyperkalemia with the aim of improving adherence and compliance with potentially better efficacy and safety. Preparing NDA Submission for Tenapanor for IBS-C: Ardelyx has completed its T3MPO program designed to support the registration of tenapanor for the treatment of irritable bowel syndrome with constipation (IBS-C). Both the T3MPO-1 and T3MPO-2 Phase 3 clinical trials achieved their primary endpoints and demonstrated that tenapanor had a durable effect on reducing constipation and abdominal pain caused by IBS-C, in many patients treated. The favorable safety profile of tenapanor was supported by the completed T3MPO-3 long-term, safety extension study. With the completion of clinical development for this program, Ardelyx is preparing a New Drug Application for tenapanor for IBS-C, which the company currently intends to submit to the U.S. Food and Drug Administration in the second half of 2018.