THE WOODLANDS, Texas - Lexicon Pharmaceuticals , Inc. (NASDAQ:LXRX) today announced an upcoming meeting with the U.S. Food and Drug Administration's (FDA) Endocrinologic and Metabolic Drugs Advisory Committee to review Zynquista™ (sotagliflozin). The meeting, scheduled for October 31, 2024, will focus on the drug's use as an adjunct to insulin therapy for glycemic control in adults with type 1 diabetes and chronic kidney disease (CKD).
The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA remains set for December 20, 2024. Lexicon's CEO, Dr. Mike Exton, expressed the company's anticipation for the opportunity to present the evidence supporting sotagliflozin's favorable benefit/risk profile for the indicated patient population.
Zynquista is part of Lexicon's portfolio of medicines aimed at treating various diseases, with a focus on diabetes and metabolism. The company's approach to drug discovery is rooted in its Genome5000™ program, which has identified over 100 protein targets with therapeutic potential.
The FDA intends to make background materials for the advisory committee meeting publicly available two business days before the meeting takes place. This step is part of the FDA's process in evaluating new drug applications, providing transparency and allowing public scrutiny of the data and considerations that may influence the advisory committee's recommendations.
This announcement comes as Lexicon continues its efforts to commercialize INPEFA® (sotagliflozin) for heart failure, and advance its pipeline of drug candidates for neuropathic pain, diabetes, and other indications through clinical and preclinical development.
The information in this news article is based on a press release statement from Lexicon Pharmaceuticals, Inc. It is important to note that forward-looking statements within the press release are based on current assumptions and expectations and are subject to risks and uncertainties that could cause actual results to differ materially from those projected.
In other recent news, Lexicon Pharmaceuticals has announced a strategic shift to focus on its heart failure drug, INPEFA, and the anticipated launch of ZYNQUISTA, a treatment for type 1 diabetes and chronic kidney disease. The company expects this move to save around $40 million in operating costs for 2025. This change comes along with a reduction of its field force by approximately 50%, while maintaining funding for its research and development programs.
In their second quarter 2024 earnings call, Lexicon reported a net loss of $53.4 million, despite growth in their INPEFA business. The earnings report revealed revenues of $1.6 million for the quarter, primarily from INPEFA sales, and the company closed with $310 million in cash and investments. The report also highlighted advancements in their drug pipeline, including the resubmission of their New Drug Application for Zynquista and progress in their LX9211 and LX9851 drug candidates.
Lexicon has initiated patient enrollment for the Phase 3 SONATA trial of sotagliflozin in hypertrophic cardiomyopathy (HCM). Furthermore, the company anticipates top-line data for the LX9211 study in diabetic peripheral neuropathic pain by Q2 2025 and is advancing LX9851 into preclinical development for obesity and weight management. In terms of future expectations, Lexicon is preparing for the potential launch of Zynquista in early 2025 and expects final data for the HCM program by the end of 2026 or early 2027.
InvestingPro Insights
As Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX) prepares for its crucial meeting with the FDA, investors and industry observers are closely monitoring the company's financial health and market performance. According to InvestingPro data, Lexicon boasts a market capitalization of approximately $607.31 million, underscoring its significant presence in the biotech sector.
Despite the challenges faced by many companies in this space, Lexicon holds more cash than debt on its balance sheet, which is an InvestingPro Tip that could signal financial stability and resilience. This is particularly noteworthy as the company navigates the costly process of drug development and regulatory approval. Additionally, analysts have revised their earnings upwards for the upcoming period, suggesting a positive outlook on the company's financial prospects.
InvestingPro data also reveals that Lexicon experienced a staggering revenue growth of 794.59% over the last twelve months as of Q2 2024, indicating a strong trajectory in sales. However, it's important to note that the company has been grappling with weak gross profit margins, as evidenced by a gross profit margin of -1674.48% over the same period.
As Lexicon advances its pipeline, including Zynquista for the treatment of type 1 diabetes and CKD, investors may find these financial insights valuable. For those interested in a deeper analysis, there are additional InvestingPro Tips available at https://www.investing.com/pro/LXRX, which can provide further guidance on the company's performance and outlook.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.