Lexicon Preparing to Resubmit Sotagliflozin NDA for Type 1 Diabetes Following Feedback From FDA
Lexicon Pharmaceuticals, Inc. (LXRX)
Last lexicon pharmaceuticals, inc. earnings: 4/27 07:00 am
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Source: GlobeNewswire
Preparations Underway for Resubmission of New Drug Application for Sotagliflozin as an Adjunct to Insulin Therapy for Glycemic Control in Patients with Type 1 Diabetes and Chronic Kidney Disease Resubmission is Anticipated Mid-2024 THE WOODLANDS, Texas, March 11, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today announced that, following the receipt of recent feedback from FDA, it is preparing to resubmit its New Drug Application (NDA) for sotagliflozin as an adjunct to insulin therapy for glycemic control in patients with type 1 diabetes and chronic kidney disease (CKD). The resubmission is planned for mid-year, with an anticipated six-month regulatory review period. “We have remained steadfast in our support of sotagliflozin in type 1 diabetes and have worked diligently to identify a regulatory path forward for what we believe will be an important new therapy,” said Lonnel Coats, Director and Chief Executive Officer. “We will now focus those efforts o
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News
- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX) Q1 2024 Earnings Call Transcript [Yahoo! Finance]Yahoo! Finance
- Lexicon Pharmaceuticals, Inc. (NASDAQ: LXRX) had its "hold" rating re-affirmed by analysts at Needham & Company LLC.MarketBeat
- Lexicon Pharmaceuticals (LXRX) Reports Q1 Loss, Misses Revenue Estimates [Yahoo! Finance]Yahoo! Finance
- Lexicon Pharmaceuticals Reports First Quarter 2024 Financial Results and Provides Business Update [Yahoo! Finance]Yahoo! Finance
- Lexicon Pharmaceuticals Reports First Quarter 2024 Financial Results and Provides Business UpdateGlobeNewswire
LXRX
Earnings
- 5/2/24 - Miss
LXRX
Sec Filings
- 5/2/24 - Form 10-Q
- 5/2/24 - Form 8-K
- 4/29/24 - Form 4
- LXRX's page on the SEC website