Lexicon Pharmaceuticals Announces FDA Advisory Committee Meeting for Zynquista

Rhea-AI Summary

Lexicon Pharmaceuticals (Nasdaq: LXRX) announced that the FDA will hold an advisory committee meeting on October 31, 2024, to review Zynquista™ (sotagliflozin) as an adjunct to insulin therapy for glycemic control in adults with type 1 diabetes and chronic kidney disease (CKD). The PDUFA goal date remains December 20, 2024. The FDA plans to make background materials public two business days before the meeting. Lexicon's CEO, Dr. Mike Exton, expressed enthusiasm about sharing evidence supporting Zynquista's favorable benefit/risk profile for the target patient group.

Positive

• FDA advisory committee meeting scheduled, indicating progress in the approval process
• PDUFA goal date maintained, suggesting no delays in the review timeline
• Potential approval for a new treatment option in a specific patient population (type 1 diabetes with CKD)

Negative

• Advisory committee review adds uncertainty to the approval process
• Approval is not guaranteed, posing a risk to the company's product pipeline

Insights

Medical Research Analyst

The FDA's decision to convene an advisory committee meeting for Zynquista (sotagliflozin) is a significant milestone in the drug's approval process. This meeting will critically evaluate the drug's safety and efficacy profile for its proposed use in type 1 diabetes patients with chronic kidney disease.

Key points to consider:

• The advisory committee's recommendation, while not binding, often heavily influences the FDA's final decision.
• The focus on patients with both type 1 diabetes and CKD suggests a potentially niche but high-need market.
• If approved, Zynquista could become the first dual SGLT1/2 inhibitor for this specific patient population, potentially offering a unique treatment option.

Investors should closely monitor the outcome of this meeting, as it will likely have a substantial impact on Lexicon's near-term prospects and the potential market reception of Zynquista.

Financial Analyst

The announcement of the FDA advisory committee meeting for Zynquista is a pivotal event for Lexicon Pharmaceuticals. Here's why it matters:

• Regulatory Progress: This meeting indicates that the FDA review is progressing, maintaining the December 20, 2024 PDUFA date.
• Market Opportunity: Approval could open a new revenue stream in the lucrative diabetes market, specifically targeting a subset with chronic kidney disease.
• Investor Sentiment: The outcome of this meeting will likely cause significant volatility in Lexicon's stock price.

However, investors should be cautious. While positive committee feedback could boost the stock, a negative outcome could lead to a sharp decline. It's important to consider Lexicon's pipeline diversity and financial health when assessing the company's overall investment potential in light of this upcoming regulatory milestone.

Advisory Committee Meeting Scheduled for October 31, 2024; PDUFA Goal Date Remains December 20, 2024

Lexicon Seeks Approval for ZYNQUISTA™ (sotagliflozin) as an Adjunct to Insulin Therapy for Glycemic Control in Adults with Type 1 Diabetes and Chronic Kidney Disease

THE WOODLANDS, Texas, Aug. 21, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today announced that the U.S. Food and Drug Administration (FDA) expects to convene a meeting of the Endocrinologic and Metabolic Drugs Advisory Committee for Zynquista™ (sotagliflozin) as an adjunct to insulin therapy for glycemic control in adults with type 1 diabetes and chronic kidney disease (CKD) on October 31, 2024, with no change to the PDUFA goal date of December 20, 2024. According to the notice provided, the FDA intends to make the background materials available to the public no later than two business days before the meeting.

“Lexicon looks forward to the opportunity to share the breadth of evidence that has been generated to support the favorable benefit/risk profile of sotagliflozin for glycemic control in people with type 1 diabetes and CKD,” said Dr. Mike Exton, chief executive officer and director.

About Lexicon Pharmaceuticals   

Lexicon is a biopharmaceutical company with a mission of pioneering medicines that transform patients’ lives. Through the Genome5000™ program, Lexicon’s unique genomics target discovery platform, Lexicon scientists studied the role and function of nearly 5,000 genes and identified more than 100 protein targets with significant therapeutic potential in a range of diseases. Through the precise targeting of these proteins, Lexicon is pioneering the discovery and development of innovative medicines to treat disease safely and effectively. Lexicon has commercially launched one of these medicines, INPEFA^® (sotagliflozin) in the United States, and has a pipeline of other promising drug candidates in discovery and clinical and preclinical development in neuropathic pain, diabetes and metabolism and other indications. For additional information, please visit www.lexpharma.com.  

Safe Harbor Statement

This press release contains “forward-looking statements,” including statements relating to the therapeutic and commercial potential, research and clinical development and regulatory status of sotagliflozin in type 1 diabetes. In addition, this press release may also contain forward looking statements relating to Lexicon’s financial position and long-term outlook on its business, growth and future operating results, discovery and development of products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. All forward-looking statements are based on management’s current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including Lexicon’s ability to meet its capital requirements, successfully commercialize INPEFA^® (sotagliflozin) in heart failure, conduct preclinical and clinical development and obtain necessary regulatory approvals of sotagliflozin in type 1 diabetes and other indications, LX9211, LX9851 and its other drug candidates on its anticipated timelines, achieve its operational objectives, obtain patent protection for its discoveries and establish strategic alliances, as well as additional factors relating to manufacturing, intellectual property rights, and the therapeutic or commercial value of its drug candidates. Any of these risks, uncertainties and other factors may cause Lexicon’s actual results to be materially different from any future results expressed or implied by such forward-looking statements. Information identifying such important factors is contained under “Risk Factors” in Lexicon’s annual report on Form 10-K for the year ended December 31, 2023, and other subsequent disclosure documents filed with the Securities and Exchange Commission. Lexicon undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.

For Media and Investor Inquiries:
Lisa DeFrancesco
Lexicon Pharmaceuticals, Inc.
lexinvest@lexpharma.com

FAQ

What is the PDUFA date for Lexicon's Zynquista (LXRX)?

The PDUFA goal date for Lexicon Pharmaceuticals' Zynquista (sotagliflozin) remains December 20, 2024.

When is the FDA advisory committee meeting for Zynquista (LXRX)?

The FDA advisory committee meeting for Zynquista (sotagliflozin) is scheduled for October 31, 2024.

What is Zynquista (LXRX) being reviewed for?

Zynquista (sotagliflozin) is being reviewed as an adjunct to insulin therapy for glycemic control in adults with type 1 diabetes and chronic kidney disease.

How soon before the advisory committee meeting will the FDA release background materials for Zynquista (LXRX)?

The FDA intends to make background materials for Zynquista available to the public no later than two business days before the meeting on October 31, 2024.