THE WOODLANDS, Texas - Lexicon Pharmaceuticals , Inc. (NASDAQ: NASDAQ:LXRX) announced today that the U.S. Food and Drug Administration (FDA) has accepted the resubmission of its New Drug Application (NDA) for Zynquista™ (sotagliflozin).
The drug is being considered as an adjunct to insulin therapy to improve glycemic control in adults with type 1 diabetes and chronic kidney disease (CKD). The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date for a decision on December 20, 2024.
The resubmission is in response to the FDA’s 2019 action letter regarding the sotagliflozin NDA for type 1 diabetes. Lexicon believes in the favorable benefit/risk profile of sotagliflozin for this patient population. Dr. Mike Exton, Lexicon’s CEO, expressed the company's readiness to enter the next phase of launch preparation, anticipating the drug's potential market entry.
Zynquista would mark Lexicon's second NDA approval and commercial launch in two years, following the commercialization of INPEFA® (sotagliflozin) in the United States. Lexicon’s innovation stems from its Genome5000™ program, which has identified over 100 protein targets with therapeutic potential in various diseases. The company aims to safely and effectively treat diseases by precisely targeting these proteins.
The press release also includes forward-looking statements about the potential therapeutic and commercial prospects of sotagliflozin in type 1 diabetes, as well as Lexicon's overall financial health and future business growth. These statements involve risks and uncertainties, including the company's ability to secure necessary capital, successfully commercialize its products, and obtain regulatory approvals on anticipated timelines.
Lexicon has a pipeline of drug candidates in discovery, clinical, and preclinical development for conditions such as neuropathic pain, diabetes, metabolism, and other indications. The company's progress and strategies are detailed in its annual report on Form 10-K for the year ended December 31, 2023, and other filings with the Securities and Exchange Commission.
This article is based on a press release statement from Lexicon Pharmaceuticals, Inc.
In other recent news, Lexicon Pharmaceuticals reported a net loss of $48.4 million in Q1 2024, with a revenue of $1.1 million. Despite this, the company successfully raised $250 million in an oversubscribed offering to support their programs. In terms of leadership changes, Lexicon Pharmaceuticals announced the appointment of Michael Exton, Ph.D., as the new CEO and Jeffrey L. Wade's promotion to President and Chief Operating Officer.
These are recent developments and come with significant analyst attention. H.C. Wainwright initiated coverage on Lexicon Pharmaceuticals with a 'Buy' rating, emphasizing the company's commitment to innovative approaches and the potential of its diverse pipeline. Similarly, Piper Sandler reaffirmed its 'Overweight' rating on Lexicon's stock, pointing to the upcoming launch of INPEFA and the expansion of sotagliflozin as key catalysts.
Finally, the company provided full-year expense guidance, projecting R&D expenses between $70 million to $80 million and total operating expenses ranging from $210 million to $235 million. These updates reflect Lexicon Pharmaceuticals' ongoing progress and future plans.
InvestingPro Insights
As Lexicon Pharmaceuticals, Inc. (NASDAQ: LXRX) gears up for the anticipated FDA decision on Zynquista™, a closer look at the company's financial health through InvestingPro metrics reveals a mixed landscape. The company's market cap stands at a modest $766.36 million, reflecting investor sentiment and the scale of the business in the biopharmaceutical industry.
From a valuation standpoint, Lexicon's P/E ratio is negative at -2.48, indicating that the company is not currently profitable. This aligns with the InvestingPro Tips, which caution that analysts do not expect the company to be profitable this year.
Moreover, the company's significant revenue growth of 1733.33% over the last twelve months as of Q1 2024 suggests that Lexicon is expanding its revenue base, although this growth comes from a relatively small base given the total revenue of $2.31 million.
InvestingPro Tips highlight that Lexicon holds more cash than debt on its balance sheet, which is a positive sign for its financial stability and ability to fund ongoing operations. Additionally, despite the challenges, analysts anticipate sales growth in the current year, which could be bolstered by the potential approval and launch of Zynquista™.
For investors looking for more in-depth analysis, there are 13 additional InvestingPro Tips available for Lexicon, which can be accessed at: https://www.investing.com/pro/LXRX. These tips provide a broader view of the company's performance metrics and future prospects. To explore these insights, use coupon code PRONEWS24 to get up to 10% off a yearly Pro and a yearly or biyearly Pro+ subscription, enhancing your investment research with comprehensive data and expert analysis.
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