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Last $10.95 USD
Change Today -0.01 / -0.09%
Volume 78.5K
ARDX On Other Exchanges
As of 4:30 PM 05/29/15 All times are local (Market data is delayed by at least 15 minutes).

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ardelyx inc (ARDX) Details

Ardelyx, Inc. discovers, develops, and commercializes minimally-systemic small molecule therapeutics for the gastrointestinal (GI) tract to treat cardio-renal, GI, and metabolic diseases. Its lead product candidate is tenapanor, a small molecule NHE3 inhibitor, which has completed Phase 2b clinical trial for the treatment of patients with constipation-predominant irritable bowel syndrome and hyperphosphatemic patients with chronic kidney disease on dialysis, as well as Phase 2a clinical trial in patients with late-stage chronic kidney disease. The company’s discovery and lead development programs that are in research phase include RDX002 NaP2b inhibitor for hyperphosphatemia; RDX009 TGR5 agonists for inflammatory bowel disease, short bowel syndrome, and non-alcoholic steatohepatitis; and RDX013 for hyperkalemia. It has a collaboration partnership agreement with AstraZeneca AB for the development and commercialization of tenapanor. The company was formerly known as Nteryx, Inc. and changed its name to Ardelyx, Inc. in June 2008. Ardelyx, Inc. was founded in 2007 and is headquartered in Fremont, California.

34 Employees
Last Reported Date: 03/5/15
Founded in 2007

ardelyx inc (ARDX) Top Compensated Officers

Chief Executive Officer, President and Direct...
Total Annual Compensation: $466.0K
Chief Financial Officer
Total Annual Compensation: $318.9K
Senior Vice President of Drug Development
Total Annual Compensation: $277.5K
Chief Scientific Officer and Executive Vice P...
Total Annual Compensation: $132.1K
Compensation as of Fiscal Year 2014.

ardelyx inc (ARDX) Key Developments

Ardelyx, Inc. Presents Positive Results from Its Phase 2b Clinical Trial

Ardelyx, Inc. presented Phase 2b clinical trial results that demonstrated statistically significant and clinically meaningful improvement in IBS-C symptoms for tenapanor-treated patients compared to patients receiving placebo. As previously reported, at the 50 mg dose of tenapanor, the study met its primary efficacy endpoint of an increase in the complete spontaneous bowel movement (CSBM) responder rate. Most secondary endpoints, including abdominal pain and other abdominal and IBS-C symptoms, demonstrated clinically meaningful improvements. Tenapanor was well-tolerated, and the safety results were consistent with those observed in previous tenapanor trials. The Phase 2b clinical trial was a randomized, double blind, placebo-controlled, multi-center study to evaluate the safety and efficacy of three dose levels of tenapanor in 356 subjects with IBS-C as defined by the Rome III criteria and who had active disease as determined during a two-week screening period. Subjects who qualified and who were randomized into the study received 5, 20, or 50 mg of tenapanor or placebo twice daily for 12 consecutive weeks. At the end of this treatment period, subjects were followed for an additional 4 weeks. The primary endpoint, overall CSBM responder rate, was achieved in 60.7% of patients receiving tenapanor 50 mg twice daily versus 33.7% receiving placebo (p < 0.001). A responder was defined as a patient who had an increase of greater than or equal to one CSBM from baseline during 6 out of 12 weeks. The results are reported on an intent-to-treat basis. The overall abdominal pain responder rate was achieved in 65.5% of patients receiving tenapanor 50 mg twice daily versus 48.3% receiving placebo (p = 0.026). An overall abdominal pain responder was defined as a patient who experienced at least a 30% decrease in abdominal pain from baseline for 6 of 12 weeks. The overall responder rate, or dual composite endpoint percent was achieved in 50.0% of patients receiving tenapanor 50 mg twice daily versus 23.6% receiving placebo (p < 0.001). An overall responder was defined as a patient who was both an overall CSBM responder and an overall abdominal pain responder in the same week for 6 of 12 weeks. A dose response relationship among all doses was observed in the primary endpoint, as well as in most secondary endpoints, although statistical significance was not achieved at the 5 mg or 20 mg doses. Additionally, the activity of tenapanor was maintained throughout the entire 12-week treatment period. Tenapanor was well-tolerated in these patients, and the safety results were consistent with those observed in previous tenapanor trials. The most common adverse events at 50 mg twice daily (greater than or equal to 5%) that occurred more frequently in tenapanor-treated patients compared to placebo-treated patients were diarrhea at 11.2% vs. 0%, and urinary tract infections at 5.6% vs. 4.4%. Overall rates of discontinuation due to adverse events were 4.5% (3.3% due to diarrhea) for the tenapanor-treated patients (50 mg twice daily) and 3.3% for the placebo-treated patients. Based on the analysis of plasma samples tested as part of the study, the minimally systemic nature of tenapanor was confirmed.

Ardelyx, Inc. Announces Unaudited Financial Results for the First Quarter Ended March 31, 2015

Ardelyx, Inc. announced unaudited financial results for the first quarter ended March 31, 2015. For the quarter, the company reported total revenues of $5,883,000 against $8,550,000 a year ago. Total revenue is comprised of licensing revenue and collaborative development revenue. Licensing revenue for the first quarter of 2015 increased to $3.9 million from $3.2 million for the first quarter of 2014. The increase was primarily due to the amortization of deferred revenue from a milestone payment of $25.0 million that the Company received in May 2014. Loss from operations was $3,490,000 against $464,000 a year ago. Net loss was $3,502,000 against $3,071,000 a year ago. Basic and diluted net loss per share was $0.19 against $2.44 a year ago.

Ardelyx Announces Tenapanor Fails to Meet Primary Endpoint in Study

Ardelyx (ARDX) announced 154-patient Phase 2a clinical trial evaluating tenapanor in Stage 3 chronic kidney disease patients with type 2 diabetes mellitus and albuminuria did not meet the primary endpoint of decreasing the urinary albumin-creatinine ratio in tenapanor-treated patients compared to patients receiving placebo. Under the terms of an agreement with AstraZeneca (AZN), AstraZeneca is obligated to communicate to Ardelyx, on or before June 29, whether it will continue the development of tenapanor. Should AstraZeneca decide to pursue the development of only the IBS-C indication, Ardelyx will be entitled to a milestone payment of $10 million. Should AstraZeneca decide to pursue the development of any other indication or multiple indications, Ardelyx will be entitled to receive a $20 million milestone payment.


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