Lexicon Announces Outcome of FDA Advisory Committee for Zynquista™ (sotagliflozin) as an Adjunct to Insulin Therapy for Glycemic Control in Adults with Type 1 Diabetes and Chronic Kidney D...
Lexicon Pharmaceuticals, Inc. (LXRX)
Last lexicon pharmaceuticals, inc. earnings: 4/27 07:00 am
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Source: GlobeNewswire
THE WOODLANDS, Texas, Oct. 31, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced the outcome of the U.S. Food and Drug Administration (FDA) Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) Meeting to review the company’s New Drug Application (NDA) for Zynquista (sotagliflozin), an oral SGLT1/SGLT2 inhibitor, as an adjunct to insulin therapy for glycemic control in adults with type 1 diabetes (T1D) and chronic kidney disease (CKD). The Advisory Committee voted 11 to 3 that the benefits of Zynquista do not outweigh the risks in adults with T1D and CKD, as defined in the voting question as having estimated glomerular filtration rate (eGFR) 45 to 2 or eGFR 60 mL/min/1.73 m2 and urine albumin-to-creatinine ratio (uACR) 30mg/g. As part of the discussion, certain committee members expressed support for sotagliflozin in alternative sub-populations of people with T1D and CKD, where they believed the benefits potentially outweigh the risks.
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LXRX
News
- Lexicon Pharmaceuticals, Inc. (NASDAQ: LXRX) had its "hold" rating re-affirmed by analysts at Needham & Company LLC.MarketBeat
- Lexicon to Reposition as Clinical Development-Focused Company Following Regulatory Update From FDA [Yahoo! Finance]Yahoo! Finance
- Lexicon to Reposition as Clinical Development-Focused Company Following Regulatory Update From FDAGlobeNewswire
- Lexicon Appoints Ivan H. Cheung to Board of Directors [Yahoo! Finance]Yahoo! Finance
- Lexicon Appoints Ivan H. Cheung to Board of DirectorsGlobeNewswire
LXRX
Earnings
- 11/12/24 - Miss
LXRX
Sec Filings
- 11/22/24 - Form 8-K
- 11/20/24 - Form 8-K
- 11/14/24 - Form SC
- LXRX's page on the SEC website