Lexicon Pharmaceuticals, Inc. (LXRX) announced that the FDA plans to hold an advisory panel meeting to give a recommendation on whether to approve Zynquista (sotagliflozin), which has been developed as an adjunct to insulin therapy for glycemic control in adults with type 1 diabetes and chronic kidney disease (CKD). The meeting of the Endocrinologic and Metabolic Drugs Advisory Committee is scheduled to be held on Oct 31, 2024. However, despite scheduling an advisory committee meeting, the FDA did not chang ...

Lexicon Pharmaceuticals, Inc. (LXRX) announced a strategic review, including the reprioritization of its current portfolio of marketed products and pipeline candidates and reducing operational expenses, to drive future business growth. As part of the portfolio reprioritization, LXRX is looking to reduce its current headcount by almost 50%, which is likely to be completed later in the ongoing quarter. Owing to this, the company expects to reduce its operating costs by $40 million in 2025. The company also re ...

Company to Focus on Targeted Promotion of INPEFA® in Heart Failure While Prioritizing Investment in the Potential Launch of ZYNQUISTA™ Efforts Expected to Reduce 2025 Operating Costs by $40 Million THE WOODLANDS, Texas, Aug. 13, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today announced that, following a strategic review of its commercial and pipeline programs, it will refocus resources across the portfolio in support of opportunities where the company believes it can have the gr ...

THE WOODLANDS, Texas, Aug. 07, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that three poster presentations will be delivered during the 2024 Annual Conference of the Association of Diabetes Care & Education Specialists being held August 9 - 12, 2024 at the Ernest N. Morial Convention Center in New Orleans, Louisiana. Posters will be displayed in the poster area of Exhibition Hall B from Friday, August 9 through Sunday, August 12. All three presentations will occur o ...

THE WOODLANDS, Texas, Aug. 07, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX) today announced that three poster presentations will be delivered during the 2024 Annual Conference of the Association of Diabetes Care & Education Specialists being held August 9 - 12, 2024 at the Ernest N. Morial Convention Center in New Orleans, Louisiana. Posters will be displayed in the poster area of Exhibition Hall B from Friday, August 9 through Sunday, August 12. All three presentations will occur on ...

2Q24 Earnings Presentation ‹#› Forward-Looking Statements • This presentation, including any oral presentation accompanying it, contains "forward-looking statements," including statements about Lexicon's strategy and operating performance and events or developments that we expect or anticipate will occur in the future, such as projections of our future results of operations or of our financial condition, the potential therapeutic and commercial potential of INPEFA® (sotagliflozin), ZYNQUISTA™ (sotagliflozin ...

Financial Data and Key Metrics Changes - Net sales for Q2 2024 were $1.6 million, with $2.7 million for the first half of 2024, showing significant growth compared to minimal revenues in the same period of 2023 [25][26] - R&D expenses increased to $17.6 million from $14.5 million in Q2 2023, primarily due to higher external R&D expenses [25] - SG&A expenses rose to $39.2 million from $30 million in Q2 2023, reflecting investments in the commercial launch of INPEFA [26] - Net loss for Q2 2024 was $53.4 million, or $0.17 per share, compared to a net loss of $44.9 million, or $0.22 per share, in Q2 2023 [26] Business Line Data and Key Metrics Changes - INPEFA's net sales showed modest growth, with improvements in filled TRx and the number of new prescribers, achieving a payer coverage of 48% [12][13] - Zynquista's NDA was resubmitted, with a PDUFA goal date set for December 20, 2024, indicating potential for commercial launch in early 2025 [7][15] - The Phase 3 study for Sotagliflozin in hypertrophic cardiomyopathy (HCM) is underway, with patient enrollment already initiated [7][18] Market Data and Key Metrics Changes - The market for SGLT therapies in heart failure remains underpenetrated, with significant growth potential despite strong recommendations in treatment guidelines [14] - The expected market access environment for Zynquista in Type 1 diabetes is anticipated to be more favorable than in heart failure, with over 400,000 adults in the U.S. potentially eligible for treatment [16][17] Company Strategy and Development Direction - The company aims to transform treatment landscapes across multiple therapeutic areas, focusing on innovative therapies and addressing unmet medical needs [6][11] - The strategic focus includes leveraging existing commercial infrastructure for Zynquista, targeting a concentrated group of endocrinologists [35] - The company is evaluating its strategy and resources to optimize success across its programs, with a focus on large markets and unmet needs [28][51] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming opportunities, including the potential launch of Zynquista and the initiation of the SONATA Phase 3 study for HCM [27][29] - The company is optimistic about the unique advantages of its drug candidates, particularly in addressing unmet needs in various therapeutic areas [10][11] Other Important Information - The company has a strong cash position, ending the quarter with $310 million in cash and investments [25] - LX9211 is on track for top-line data in Q2 2025, with significant potential in neuropathic pain treatment [21][22] - LX9851 is progressing into preclinical development, targeting obesity and weight management with a unique mechanism [23][24] Q&A Session Summary Question: Updates on Zynquista and its launch trajectory - Management discussed the preparation for an advisory committee meeting and the focus on the risk-benefit profile for Zynquista, particularly in patients with chronic kidney disease [30][32] - The commercial strategy involves leveraging existing sales teams to target endocrinologists, with expectations of a more concentrated market compared to heart failure [35][36] Question: AdCom preparations and launch strength comparison - Management confirmed preparations for the AdCom will focus on risk-benefit discussions, with expectations for a stronger launch trajectory for Zynquista compared to INPEFA due to unmet needs in the Type 1 diabetes market [37][40] Question: HCM program evolution and timelines - The HCM program is expected to have final data towards the end of 2026 or early 2027, with a treatment duration shorter than typical due to prior successes in related indications [49][50] Question: Feedback from trial sites and execution standards - Positive feedback has been received from trial sites, with a focus on the ease of patient enrollment and execution of the SONATA trial [52][53] Question: Safety profile of LX9851 and its applicability - Management expressed confidence in the safety profile of LX9851, with ongoing studies to assess long-term effects and potential applicability in other metabolic conditions [66][70]

Lexicon Pharmaceuticals (LXRX) came out with a quarterly loss of $0.17 per share versus the Zacks Consensus Estimate of a loss of $0.18. This compares to loss of $0.22 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of 5.56%. A quarter ago, it was expected that this drugmaker would post a loss of $0.18 per share when it actually produced a loss of $0.20, delivering a surprise of -11.11%. Over the last four quarters, the company ...

Company Overview - Lexicon Pharmaceuticals, Inc. is a biopharmaceutical company focused on pioneering medicines that transform patients' lives through innovative drug discovery and development [3]. - The company has studied nearly 5,000 genes through its Genome5000™ program, identifying over 100 protein targets with significant therapeutic potential across various diseases [3]. Product Pipeline - Lexicon is commercially launching INPEFA® (sotagliflozin) in the United States and has a pipeline of promising drug candidates in discovery and clinical and preclinical development targeting neuropathic pain, diabetes, metabolism, and other indications [3]. Financial Information - Lexicon is set to release its second quarter 2024 financial results on August 1, 2024, after market close, followed by a conference call and live webcast to discuss the results and provide a business update [4].

Image Source: Zacks Investment Research An oral SGLT inhibitor, the commercial launch of Inpefa continues to progress across the country, driven by demand across the cardiology community and improving payer access. We remind investors that sotagliflozin was approved by the FDA last year to reduce the risk of death and hospitalization in adults with either heart failure or those with type II diabetes mellitus (T2D), CKD and other cardiovascular risk factors. The drug is being marketed under the name Inpefa. ...