Lexicon Pharmaceuticals Receives Formal Dispute Resolution Request Decision From FDA’s Office of New Drugs for Sotagliflozin in Type 1 Diabetes
Lexicon Pharmaceuticals, Inc. (LXRX)
Last lexicon pharmaceuticals, inc. earnings: 4/27 07:00 am
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Source: GlobeNewswire
THE WOODLANDS, Texas, Dec. 02, 2019 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today announced that the Office of New Drugs of the U.S. Food and Drug Administration (FDA) has reiterated the FDA's prior position and denied Lexicon's appeal of the Complete Response Letter in relation to the New Drug Application for sotagliflozin (ZynquistaTM) in type 1 diabetes. Lexicon intends to appeal the decision to the Center for Drug Evaluation and Research, or CDER. Conference Call Information Lexicon management will hold a live conference call today, December 2, 2019, at 8:00 am EST / 7:00 am CST to discuss today’s announcement. The dial-in number for the conference call is 888-645-5785 (U.S./Canada) or 970-300-1531 (international). The conference ID for all callers is 1857906. The replay may be accessed by visiting Lexicon’s website at www.lexpharma.com/investors and will be available on the website for 14 days. About Zynquista (sotagliflozin)
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