Core Insights - Lexicon Pharmaceuticals is preparing for the launch of Zynquista™ (sotagliflozin) as an adjunct to insulin therapy for glycemic control in adults with type 1 diabetes and chronic kidney disease, with a PDUFA goal date set for December 20, 2024 [1][2] Group 1: Company Overview - Lexicon Pharmaceuticals is a biopharmaceutical company focused on pioneering medicines that transform patients' lives through its Genome5000™ program, which has identified over 100 protein targets with significant therapeutic potential [3] - The company has successfully launched INPEFA® (sotagliflozin) in the United States and has a pipeline of promising drug candidates in various stages of development, including neuropathic pain and diabetes [3] Group 2: Regulatory and Market Position - The FDA has acknowledged the resubmission of Lexicon's New Drug Application (NDA) for sotagliflozin, indicating it is a complete response to the previous action letter from 2019 [1] - If approved, Zynquista will represent Lexicon's second NDA approval and commercial launch within two years, showcasing the company's ability to advance products from discovery to regulatory approval [2]

Core Viewpoint - Lexicon Pharmaceuticals has appointed Mike Exton, Ph.D. as the new CEO, succeeding Lonnel Coats, who retired on July 7, 2024. Dr. Exton brings extensive experience from Novartis, particularly in cardiometabolic therapeutics [1][2][5]. Company Leadership Changes - Mike Exton has been appointed as CEO and director of Lexicon Pharmaceuticals, with a focus on executing near-term objectives to drive future value [1][2]. - Jeff Wade has been named president and chief operating officer, having previously served as president and chief financial officer since October 2021 [2]. Leadership Experience - Dr. Exton has a 14-year tenure at Novartis, where he led the commercialization of a leading heart failure drug and developed a strong cardiometabolic business [5]. - His background includes roles in research, development, commercialization, and strategic partnerships, enhancing Lexicon's management capabilities [5]. Company Overview - Lexicon Pharmaceuticals is dedicated to pioneering medicines that transform patients' lives, utilizing its Genome5000™ program to identify therapeutic protein targets [6]. - The company has launched INPEFA® (sotagliflozin) in the U.S. and has a pipeline of drug candidates in various stages of development for conditions such as neuropathic pain and diabetes [6].

Company Overview - Lexicon Pharmaceuticals has appointed Mike Exton, Ph.D. as the new chief executive officer, succeeding Lonnel Coats who retired on July 7, 2024 [7] - Dr. Exton has extensive experience in the pharmaceutical industry, including 14 years at Novartis, where he led the global cardiometabolic therapeutic area [8] - Lexicon is focused on pioneering medicines that transform patients' lives, with a unique genomics target discovery platform called Genome5000™ [9] Leadership Changes - Concurrent with Dr. Exton's appointment, Jeff Wade has been named president and chief operating officer, having previously served as Lexicon's president and chief financial officer since October 2021 [4] - The board of directors expressed confidence in Dr. Exton's leadership capabilities, highlighting his successful track record in commercialization and strategic partnerships [3] Product Pipeline and Strategy - Lexicon has commercially launched INPEFA® (sotagliflozin) in the United States and has a pipeline of promising drug candidates in various stages of development, including neuropathic pain and diabetes [9] - The company aims to achieve operational objectives and secure necessary regulatory approvals for its drug candidates, which include LX9211 and LX9851 [10]

Core Viewpoint - Lexicon Pharmaceuticals has resubmitted its New Drug Application (NDA) for sotagliflozin as an adjunct to insulin therapy for glycemic control in patients with type 1 diabetes and chronic kidney disease (CKD) following feedback from the U.S. Food and Drug Administration (FDA) [1][3][10] Group 1: Regulatory Developments - The company anticipates a six-month review period from the FDA and a potential product launch in early 2025 [3] - The NDA for sotagliflozin was previously met with a complete response letter (CRL) from the FDA in 2019, and subsequent discussions led to the current resubmission [10] - The application remains in "filed" status at the FDA, with a formal communication expected within 30 days to establish the action date [10] Group 2: Company Insights - Lexicon Pharmaceuticals is focused on pioneering medicines that transform patients' lives, utilizing its Genome5000™ program to identify therapeutic targets [7] - The company has successfully launched INPEFA® (sotagliflozin) in the U.S. and is developing additional drug candidates for various indications [7] - The CEO expressed confidence in the benefit/risk profile of sotagliflozin for patients with type 1 diabetes and CKD, emphasizing the importance of this therapy [6]

Company Anticipates Six Month Review and Potential Launch in Early 2025 "We are confident in the benefit/risk profile of sotagliflozin for people with type 1 diabetes and CKD, and our team has been resolute in identifying and pursuing a regulatory path forward," said Lonnel Coats, director and chief executive officer. "We are now one step closer to bringing this important potential therapy to market for the many people who suffer from type 1 diabetes and CKD, and who could benefit from an adjunct to insulin ...

Core Insights - Lexicon Pharmaceuticals announced the publication of a research paper on its Phase 2 RELIEF-DPN-1 clinical trial for LX9211, aimed at treating diabetic peripheral neuropathic pain (DPNP) [1][3] Summary by Sections Clinical Trial Results - The RELIEF-DPN-1 study demonstrated that LX9211 provides clinically significant benefits for patients with DPNP, with a focus on pain relief over an 11-week evaluation period [7] - The primary efficacy endpoint was the change in average daily pain score (ADPS) from baseline to week 6, which was achieved in the low-dose LX9211 group [7] - Patient-reported outcomes improved significantly in those treated with LX9211, which was generally well tolerated [7] Current Treatment Landscape - Existing therapies for DPNP offer only modest pain relief, with less than 50% of patients achieving a 50% reduction in pain severity [2] - Many patients continue to use opioids as first-line therapy despite the associated high risks and complications, including mortality [2] Future Developments - The positive outcomes from the RELIEF-DPN-1 study support the initiation of Lexicon's larger Phase 2b PROGRESS trial, which is currently enrolling patients across the United States [3][15] - LX9211 has received Fast Track designation from the U.S. FDA for its development in DPNP, indicating its potential significance in addressing this medical need [11] Company Overview - Lexicon Pharmaceuticals is focused on pioneering innovative medicines, having launched INPEFA® (sotagliflozin) and developing a pipeline of drug candidates targeting neuropathic pain, diabetes, and metabolism [10] - The company utilizes its Genome5000™ program to identify therapeutic targets, having discovered over 100 protein targets with significant potential [10]

Investigators conclude that clinical outcomes of RELIEF-DPN 1 support commencement of Lexicon's dose-ranging Phase 2b PROGRESS trial, currently enrolling patients In the proof-of-concept RELIEF-DPN-1 study, the effects of LX9211 were assessed over an 11-week evaluation period, which included a six-week double-blind treatment period and a 5-week single-blind safety follow-up period. The primary efficacy endpoint under evaluation was the change from baseline to week 6 in average daily pain score (ADPS), which ...

Company Overview - Lexicon Pharmaceuticals is a biopharmaceutical company focused on pioneering medicines that transform patients' lives through innovative drug discovery and development [4][12]. - The company has launched INPEFA® (sotagliflozin) in the United States and is developing a pipeline of other drug candidates targeting various diseases, including neuropathic pain and diabetes [4][12]. Product Information - INPEFA® (sotagliflozin) is an oral inhibitor of SGLT2 and SGLT1, which are proteins involved in glucose regulation [5]. - Sotagliflozin has been studied in clinical trials involving approximately 20,000 patients across multiple populations, including those with heart failure and diabetes [5]. Research Findings - A recent study published in the Journal of Comparative Effectiveness Research concluded that INPEFA is cost-effective for patients with diabetes and recent worsening heart failure, demonstrating a net gain in quality-adjusted life years (QALYs) of 0.425 compared to standard care [2][12]. - The analysis indicated that lifetime QALYs were 4.43 for the INPEFA group versus 4.04 for the placebo group, reinforcing the financial value of INPEFA for the U.S. healthcare system [13][14]. Clinical Implications - The findings suggest that INPEFA not only provides clinical benefits to heart failure patients but also offers significant economic value for payors [14]. - The research supports the use of INPEFA as a cost-effective addition to standard care for patients hospitalized with heart failure and comorbid diabetes [2][12].

Company Overview - Lexicon Pharmaceuticals, Inc. is a biopharmaceutical company focused on pioneering medicines that transform patients' lives, with a unique genomics target discovery platform called Genome5000™ [4][5] - The company has commercially launched one medicine, INPEFA® (sotagliflozin), in the United States and has a pipeline of promising drug candidates in various stages of development for neuropathic pain, diabetes, metabolism, and other indications [5][6] Research Presentations - Lexicon will present three poster presentations at the 84th Scientific Sessions of the American Diabetes Association from June 21 - 24, 2024, in Orlando, Florida [4] - The presentations include topics such as the burden of diabetic peripheral neuropathic pain and the impact of sotagliflozin as an add-on treatment for inadequately controlled type 2 diabetes [5] Drug Development - LX9211 is an investigational small molecule inhibitor of adaptor-associated kinase 1 (AAK1), identified as a promising treatment for neuropathic pain, with preclinical studies showing effectiveness without affecting opiate pathways [6] - Sotagliflozin is an oral inhibitor of SGLT2 and SGLT1 proteins, studied in clinical trials involving approximately 20,000 patients across various conditions including heart failure and chronic kidney disease [7]

THE WOODLANDS, Texas, June 14, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that three poster presentations will be delivered during the 84th Scientific Sessions of the American Diabetes Association being held June 21 - 24, 2024 at the Orange County Convention Center in Orlando, Florida. All three poster presentations will occur on Sunday, June 23, 12:30 - 1:30 p.m. ET, in the Poster Hall (West A4-B2). Details are as follows: "Patient-Reported Burden of Disease in Di ...