ARDELYX WKN: A116X0 ISIN: US0396971071 Kürzel: ARDX Forum: Aktien Thema: Hauptdiskussion

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FREMONT, Calif. and WALTHAM, Mass., July 19, 2021 /PRNewswire/ -- 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 it received a letter from the U.S. Food and Drug Administration (the "FDA") 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. The letter stated that the notification does not reflect a final decision on the information under review. The company immediately requested a meeting to discuss the deficiencies and was notified by the FDA today that the request for a meeting was denied.

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rdelyx Receives FDA Approval for IBSRELA® (Tenapanor), an NHE3 Sodium Transport Inhibitor, for the Treatment of Irritable Bowel Syndrome with Constipation https://www.benzinga.com/pressreleases/19/09/n14424331/ardelyx-receives-fda-approval-for-ibsrela-tenapanor-an-nhe3-sodium-transport-inhibitor-for-the-tre https://seekingalpha.com/article/4291196-ardelyx-advances-drug-chronic-kidney-disease-soc-treatment-lacks

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Back YahooFINANCE Ardelyx Announces Positive Results from the Pivotal Phase 3 AMPLIFY Study Evaluating Tenapanor in Dialysis Patients Who Have Uncontrolled Hyperphosphatemia Despite Phosphate Binder Treatment  PR NewswireSeptember 3, 2019, 2:00 PM GMT+2 The primary and all key secondary endpoints were met. Tenapanor in combination with binders met the primary endpoint demonstrating a statistically significant (p=0.0004) reduction of serum phosphorus compared to binders alone. Approximately two times more patients achieved the established serum phosphorus treatment goal of less than 5.5mg/dL in the tenapanor arm compared to binders alone (p -values≤0.0097) for each week of treatment. https://finance.yahoo.com/news/ardelyx-announces-positive-results-pivotal-120000881.html

Ardelyx to Host Conference Call on September 3 to Review Results from the Pivotal Phase 3 AMPLIFY Study https://finance.yahoo.com/news/ardelyx-host-conference-call-september-200000222.html?guccounter=1&guce_referrer=aHR0cHM6Ly93d3cuZ29vZ2xlLmNvbS8&guce_referrer_sig=AQAAANkKburamt2MoGzIWIKz0iY0LmQIcEbydIrL79nnuKr9peohRpAnysLaqxVCFgFmmEDtffSlmaWxHeitbJ-NSQADMjoknpsuk-vMslm7b16hO4rtMI2cVOC4xAoNYS4ByaGNG75RWZCCjCbgkdZdhBd5ybJz73x6GNB0ROLx91HP

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