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Update","url":"https://stock-news.laohu8.com/highlight/detail?id=2483009314","media":"Dow Jones","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2483009314?lang=en_us&edition=fundamental","pubTime":"2024-11-13 20:15","pubTimestamp":1731500100,"startTime":"0","endTime":"0","summary":"-- OLC New Drug Application  Accepted by the FDA with a PDUFA Target Action Date of June 28, 2025--. -- Commercial Planning in Progress for 2025 Launch --. \"We are pleased with the tremendous progress we have made over the last several months highlighted by the acceptance of our New Drug Application for oxylanthanum carbonate  which may result in the potential approval of our first drug in 2025,\" said Shalabh Gupta, M.D., Chief Executive Officer of Unicycive. \"If approved, we believe OLC's high potency and low pill burden would provide a best-in-class option for patients with chronic kidney disease  on dialysis who have hyperphosphatemia and face adherence challenges with current treatment regimens. With the NDA acceptance now behind us, we are actively preparing to commercialize OLC with the goal of bringing this innovative new treatment to market in the second half of 2025.\"","market":"hk","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://dowjonesnews.com/newdjn/logon.aspx?AL=N","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["BK4232","UNCY","BK4022","R","UNI.USD.CC","UNI.USD.HKCC"],"gpt_icon":0},{"id":"2482785481","title":"Unicycive Therapeutics Says FDA Accepts New Drug Application for Oxylanthanum Carbonate","url":"https://stock-news.laohu8.com/highlight/detail?id=2482785481","media":"MT Newswires 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approval of its lead drug candidate as a treatment for an electrolyte disorder related to kidney disease.Unicycive, which is seeking an FDA green light for oxylanthanum carbonate to treat hyperphosphatemia in patients with chronic kidney disease who are on dialysis, Monday said the agency set a target action date of June 28, 2025 for the application.The Los Altos, Calif., clinical-stage biotechnology company said oxylanthanum carbonate, if approved, would lower the pill burden in terms of the number and size per dose for patients with hyperphosphatemia, a condition involving too much phosphate in the blood that occurs in nearly all patients with end-stage renal disease.Unicycive said it was preparing to commercialize and launch the drug in the second half of 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