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

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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Ardelyx: Attractive Valuation, Upcoming Major Catalysts STRENDING PORTFOLIO PEOPLE MARKET NEWS STOCK IDEAS DIVIDENDS INVESTING STRATEGY REITS WALL STREET BREAKFAST ON THE MOVE DIVIDEND NEWS MARKET OUTLOOK  Leonard Yaffe Follow Long Ideas Healthcare  Ardelyx: Attractive Valuation, Upcoming Major Catalysts Aug. 26, 2019 6:56 PM ETArdelyx, Inc. (ARDX)5 Comments1 Like Summary Ardelyx drug, tenapanor, has been studied in two underserved markets that both exceed $1 billion in US revenues, namely IBS-C and hyperphosphatemia in dialysis patients. The FDA PDUFA date for the IBS-C indication is September 12. The company does not yet have a US marketing partner, but a favorable decision should remedy that need. Tenapanor will have data readouts on two Phase 3 studies, PHREEDOM and AMPLIFY, for the hyperphosphatemia indication this year. The drug could be on the US market in 2021. Ardelyx has $124 million in cash, $50 million in long-term debt, and 63 million shares outstanding. The quarterly cash burn rate is in the $20-25 million range. The market capitalization is $240 million. https://seekingalpha.com/article/4288036-ardelyx-attractive-valuation-upcoming-major-catalysts?source=quotemedia_readmore

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Doch, bin noch da und warte auf Anfang September. Tenapanor Small biotech Ardelyx should be only a few weeks away from some big news. The FDA is scheduled to announce an approval decision for tenapanor in treating irritable bowel syndrome with constipation (IBS-C) by Sept. 12, 2019.  EvaluatePharma expects that the drug could pull in nearly $700 million annually by 2024 if it's approved. Ardelyx hopes that the IBS-C is only the first of two approved indications for tenapanor. The company is also evaluating the drug in a phase 3 clinical study for treating hyperphosphatemia in patients with end-stage renal disease (ESRD) who are on dialysis. https://finance.yahoo.com/news/5-biggest-drug-approvals-potentially-100000979.html?.tsrc=rss&guccounter=1&guce_referrer=aHR0cHM6Ly93d3cuYmlvcGhhcm1jYXRhbHlzdC5jb20vY29tcGFueS9BUkRY&guce_referrer_sig=AQAAAB4jymk2JhW9FFWL6Ho1usfoeRVHHapqj8tXJyKDUKJ6Q6wMjbkBuk1E-iWP0dSQIU0VftwxhJPLpNTQxY0xY5xOVs-1fOLYSHDTcPfRahbQNNVYYFIe0Owu4E1GFhGi2k0aMPQbkNz9hbVMnWbOx1LCb3kV3WstS8W8ITUfTkPF

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Expected 2019 Milestones The PHREEDOM clinical trial, the company's second Phase 3 clinical trial of tenapanor for hyperphosphatemia in patients with end-stage renal disease (ESRD) who are on dialysis, is currently expected to read out in the fourth quarter of 2019. The AMPLIFY clinical trial, the company's additional Phase 3 clinical trial of tenapanor as adjunctive therapy with phosphate binders for hyperphosphatemia in patients with ESRD who are on dialysis, is currently expected to read out in the second half of 2019. The company's New Drug Application for U.S. marketing authorization of tenapanor for patients with IBS-C has a target action date under the Prescription Drug User Fee Act (PDUFA) of September 12, 2019. http://ir.ardelyx.com/news-releases/news-release-details/ardelyx-reports-first-quarter-2019-financial-results-and-recent

grüße Dich mein Freund nu... Der.... hat mich in letzter Zeit dermaßen geärgert u.beleidigt ... Wollte einen einzigen Forum haben,wo man seine Ruhe hat grins... Wenn wir zu viel posten,werden wir sofort gefunden ..

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