Lexicon Receives Complete Response Letter from FDA for Diabetes, Kidney Disease Treatment

Dow Jones

2024-12-21

By Connor Hart

Lexicon Pharmaceuticals received a complete response letter from the Food and Drug Administration for its treatment of type 1 diabetes and chronic kidney disease.

The FDA's response -- which according to the agency indicates that its review of an application is complete and the application is not ready for approval -- was expected and aligns with Lexicon's previously disclosed decision to discontinue the treatment and focus solely on its clinical development pipeline, the company said Friday.

Lexicon had been investigating the treatment, sotagliflozin, as an adjunct to insulin therapy for glycemic control in adults with type 1 diabetes and chronic kidney disease.

"Although this was not our desired outcome for sotagliflozin in this indication, we remain steadfast in our commitment to advancing our clinical pipeline," Chief Executive Mike Exton said.

Shares tumbled 13%, to 62 cents, in after-hours trading.

Write to Connor Hart at connor.hart@wsj.com

(END) Dow Jones Newswires

December 20, 2024 17:03 ET (22:03 GMT)

Copyright (c) 2024 Dow Jones & Company, Inc.

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Company, Inc.\n</p>\n</font>\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"LXRX","symbol_name":"萊斯康製藥","start_time":0,"source_url":"https://dowjonesnews.com/newdjn/logon.aspx?AL=N","article_id":"2493528477","we_media_id":"106","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2493528477","pubTimestamp":1734732180,"columns":[],"sourceInfo":null,"weMediaInfo":{"media_name":"Dow Jones","introduction":"Dow Jones publishes the world’s most trusted business news and financial information in a variety of media.","home_visible":0,"id":"106","head_image":"https://static.tigerbbs.com/150f88aa4d182df19190059f4a365e99"},"summary":"Lexicon Pharmaceuticals received a complete response letter from the Food and Drug Administration for its treatment of type 1 diabetes and chronic kidney disease.The FDA's response -- which according to the agency indicates that its review of an application is complete and the application is not ready for approval -- was expected and aligns with Lexicon's previously disclosed decision to discontinue the treatment and focus solely on its clinical development pipeline, the company said Friday.Lexicon had been investigating the treatment, sotagliflozin, as an adjunct to insulin therapy for glycemic control in adults with type 1 diabetes and chronic kidney disease.\"Although this was not our desired outcome for sotagliflozin in this indication, we remain steadfast in our commitment to advancing our clinical pipeline,\" Chief Executive Mike Exton said.Shares tumbled 13%, to 62 cents, in after-hours trading.","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{"LXRX":"莱斯康制药","BK4139":"生物科技"},"translate_title":"Lexicon收到FDA关于糖尿病、肾病治疗的完整回复信","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"LXRX":0.9},"content_text":"By Connor Hart \n\n\n  Lexicon Pharmaceuticals received a complete response letter from the Food and Drug Administration for its treatment of type 1 diabetes and chronic kidney disease. \n\n\n  The FDA's response -- which according to the agency indicates that its review of an application is complete and the application is not ready for approval -- was expected and aligns with Lexicon's previously disclosed decision to discontinue the treatment and focus solely on its clinical development pipeline, the company said Friday. \n\n\n  Lexicon had been investigating the treatment, sotagliflozin, as an adjunct to insulin therapy for glycemic control in adults with type 1 diabetes and chronic kidney disease. \n\n\n  \"Although this was not our desired outcome for sotagliflozin in this indication, we remain steadfast in our commitment to advancing our clinical pipeline,\" Chief Executive Mike Exton said. \n\n\n  Shares tumbled 13%, to 62 cents, in after-hours trading. \n\n\n  Write to Connor Hart at connor.hart@wsj.com \n\n\n \n\n\n  (END) Dow Jones Newswires\n\n\n  December 20, 2024 17:03 ET (22:03 GMT)\n\n\n  Copyright (c) 2024 Dow Jones & Company, Inc.","kind":"highlight","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"0","news_tag":"","news_rank":0,"symbols":[],"gpt_button":1,"code":"91000000","status":"200"}}}