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

Kauforder bei 1.50

Aua

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.

Wer ist am Start?

29.7 PDUFA

Kommt jetzt der Durchbruch?

Moin!

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

Tendenz hoffentlich weiter nach oben

Wow hier geht es ab

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

wieder +7%

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

bin auch investiert

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