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)
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