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THE WOODLANDS, Texas - Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX), a $432 million market cap biotech company with a ’GOOD’ InvestingPro Financial Health score, announced Monday that the U.S. Food and Drug Administration needs additional time to review clinical data supporting the potential resubmission of Zynquista (sotagliflozin) for type 1 diabetes.
The FDA now expects to provide feedback from the September Type D meeting in the fourth quarter, rather than by the end of September as previously anticipated. The news comes as Lexicon’s stock has shown remarkable strength, posting a 228% gain over the past six months. The company is seeking approval for Zynquista as an adjunct to insulin for glycemic control in adults with type 1 diabetes.
Lexicon submitted additional clinical data from ongoing third-party funded, investigator-sponsored trials following a complete response letter issued by the FDA in December 2024, which cited concerns about increased risk of diabetic ketoacidosis. While the company maintains strong liquidity with a current ratio of 4.16, InvestingPro analysis indicates the company is quickly burning through cash, a common challenge in biotech development.
The submitted data comes from three ongoing studies conducted by the Steno Diabetes Center, the Joslin Diabetes Center, and the University of Dundee, which the company believes support the benefit-risk profile of Zynquista in type 1 diabetes patients.
Sotagliflozin is an oral inhibitor of sodium-glucose cotransporter types 2 and 1 (SGLT2 and SGLT1), proteins responsible for glucose regulation. The drug has been studied in multiple patient populations including those with heart failure, diabetes, and chronic kidney disease in clinical studies involving approximately 20,000 patients.
Lexicon is seeking alignment with the FDA on a reasonable path forward for the Zynquista New Drug Application resubmission, according to the company’s press release statement. InvestingPro subscribers can access 8 additional key insights and a comprehensive analysis of Lexicon’s financial health and market position through the Pro Research Report, available exclusively on the platform.
In other recent news, Lexicon Pharmaceuticals has made notable advancements in its drug development efforts. The company has submitted additional clinical data to the U.S. Food and Drug Administration for Zynquista, a potential treatment for type 1 diabetes. This submission includes data from three ongoing studies evaluating the drug’s efficacy as an adjunct to insulin therapy. Meanwhile, H.C. Wainwright has reiterated its Buy rating with a $4.00 price target for Lexicon Pharmaceuticals, following presentations of new data at the International Congress on Neuropathic Pain and the European Society of Cardiology Congress. The presentations highlighted the potential of pilavapadin in reducing neuropathic pain and the efficacy of sotagliflozin in older heart failure patients. Jefferies, on the other hand, raised its price target for Lexicon to $0.85, maintaining a Hold rating, and noted an upcoming meeting with the FDA regarding pilavapadin for diabetic peripheral neuropathy pain. These developments reflect ongoing efforts by Lexicon to advance its therapeutic candidates and engage with regulatory authorities.
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