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THE WOODLANDS, Texas - Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX), a pharmaceutical company with a current market capitalization of $396 million, has submitted additional clinical data to the U.S. Food and Drug Administration in support of its potential resubmission of a New Drug Application for Zynquista, according to a company press release issued Monday. According to InvestingPro data, while the company maintains strong liquidity with a current ratio of 4.16, it faces challenges with rapid cash burn and negative profit margins.
The submission includes data from three ongoing third-party funded, investigator-initiated studies of sotagliflozin, an oral SGLT1/SGLT2 inhibitor being evaluated as an adjunct to insulin for glycemic control in adults with type 1 diabetes. The company’s development efforts come amid significant market interest, with the stock showing remarkable momentum - up 178% over the past six months, as revealed by InvestingPro analysis.
The FDA issued a complete response letter for Zynquista in December 2024, citing concerns about increased risk of diabetic ketoacidosis. Following discussions with the agency about potential regulatory paths forward, Lexicon has been granted a Type D meeting and expects feedback by the end of September.
The additional data comes from studies conducted by the Steno Diabetes Center, the Joslin Diabetes Center, and the University of Dundee, which the company says support the benefit-risk profile of Zynquista in type 1 diabetes.
"While we are no longer investing in clinical programs for Zynquista, we remain committed to exploring all opportunities to bring this medicine to patients, whose support for approval is unwavering," said Dr. Mike Exton, chief executive officer of Lexicon Pharmaceuticals, in the press release.
Sotagliflozin inhibits two proteins responsible for glucose regulation known as sodium-glucose cotransporter types 2 and 1. 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 awaiting the FDA’s response from the Type D meeting, which is expected before the end of September 2025. As investors monitor these developments, InvestingPro analysis indicates the stock is currently trading near its Fair Value, with analysts setting price targets ranging from $0.85 to $6.00 per share. For deeper insights into Lexicon’s financial health and growth prospects, investors can access the comprehensive Pro Research Report, available exclusively to InvestingPro subscribers.
In other recent news, Lexicon Pharmaceuticals reported a surprising earnings beat for Q2 2025, with earnings per share of $0.01, surpassing the expected loss of $0.09 per share. The company’s revenue reached $28.9 million, significantly higher than the anticipated $6.49 million, largely due to substantial licensing revenue from Novo Nordisk. Additionally, Lexicon Pharmaceuticals is set to meet with the FDA by early Q4 to discuss oral pilavapadin for diabetic peripheral neuropathy pain, a market with potential exceeding $1 billion. Jefferies has raised its price target for Lexicon Pharmaceuticals to $0.85 from $0.70 while maintaining a Hold rating. Meanwhile, H.C. Wainwright has reiterated its Buy rating with a $4.00 price target following the company’s presentation at the European Society of Cardiology Congress 2025. This presentation highlighted the efficacy of sotagliflozin in older heart failure patients. These developments reflect recent activities surrounding Lexicon Pharmaceuticals.
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