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– Results support advancement of 10 mg dose into Phase 3 development – – End-of-Phase 2 meeting request accepted by U.S. FDA; partnership discussions progressing – THE WOODLANDS, Texas, Oct. 14, 2025 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced the Company presented additional clinical data and program updates from its Phase 2 pilavapadin program at the 19th Annual Pain Therapeutics Summit. These data follow the topline results from the Phase 2b PROGRESS study of pilavapa ...

Core Insights - The roundtable discussion hosted by Lexicon Pharmaceuticals focused on enhancing legislative efforts to address chronic pain treatment needs in the U.S. [1][3] - Approximately 50 million Americans suffer from chronic pain, with associated costs reaching up to $635 billion annually [2] - The Alternatives to PAIN Act aims to improve access to non-opioid pain treatments under Medicare Part D, currently limited to acute and post-surgical pain [3][4] Legislative Focus - Participants discussed the need to expand the Alternatives to PAIN Act to include chronic pain sufferers [3] - The group emphasized the importance of innovation in pain treatment, highlighting that pain remains an undertreated condition [4] Company Overview - Lexicon Pharmaceuticals is dedicated to pioneering medicines that transform patients' lives, utilizing its Genome5000™ program for drug discovery [5] - The company has a pipeline of drug candidates targeting various conditions, including neuropathic pain and obesity [5]

Group 1: U.S. Stock Market Overview - U.S. stock futures were higher, with Dow futures gaining over 100 points on Monday [1] Group 2: Inventiva ADR Performance - Inventiva reported losses of $(1.84) per share, significantly worse than the analyst consensus estimate of a loss of 41 cents per share [1] - The company reported quarterly sales of $5.050 million, missing the analyst consensus estimate of $5.310 million [1] - Inventiva shares dipped 5.5% to $5.72 in pre-market trading [1] Group 3: Other Stocks in Pre-Market Trading - MoonLake Immunotherapeutics saw a significant decline of 86.3% to $8.50 in pre-market trading [4] - Cellectis SA declined 10.4% to $3.01 in pre-market trading [4] - Quantum-Si Inc fell 10.1% to $1.34 in pre-market trading after filing for a mixed shelf of up to $300 million [4] - Penguin Solutions Inc decreased by 8.4% to $24.00 in pre-market trading [4] - Lithium Americas Corp declined 5.4% to $5.99 in pre-market trading after a 14% drop on Monday [4] - Platinum Analytics Cayman Ltd fell 5.3% to $16.20 in pre-market trading after a 44% increase on Monday [4] - Novo Nordisk A/S decreased by 2.9% to $54.01 in pre-market trading [4] - Lexicon Pharmaceuticals Inc declined 2.9% to $1.36 in pre-market trading, recently announcing an update on submission of additional data to the U.S. FDA regarding Zynquista® in Type 1 Diabetes [4]

Group 1: U.S. Stock Market Overview - U.S. stock futures were higher, with Dow futures gaining over 100 points on Monday [1] Group 2: Inventiva ADR Performance - Inventiva reported a loss of $(1.84) per share, significantly worse than the analyst consensus estimate of a loss of 41 cents per share [1] - The company’s quarterly sales were $5.050 million, missing the analyst consensus estimate of $5.310 million [1] - Inventiva shares fell 5.5% to $5.72 in pre-market trading [1] Group 3: Other Stocks in Pre-Market Trading - MoonLake Immunotherapeutics saw a significant decline of 86.3% to $8.50 in pre-market trading [4] - Cellectis SA declined 10.4% to $3.01 in pre-market trading [4] - Quantum-Si Inc fell 10.1% to $1.34 in pre-market trading after filing for a mixed shelf of up to $300 million [4] - Penguin Solutions Inc dropped 8.4% to $24.00 in pre-market trading [4] - Lithium Americas Corp declined 5.4% to $5.99 in pre-market trading after a 14% dip on Monday [4] - Platinum Analytics Cayman Ltd fell 5.3% to $16.20 in pre-market trading after a 44% jump on Monday [4] - Novo Nordisk A/S decreased by 2.9% to $54.01 in pre-market trading [4] - Lexicon Pharmaceuticals Inc declined 2.9% to $1.36 in pre-market trading, with an update on additional data submission to the U.S. FDA regarding Zynquista® in Type 1 Diabetes [4]

Core Viewpoint - Lexicon Pharmaceuticals is facing a delay in the FDA review process for the marketing application of Zynquista (sotagliflozin) intended for adults with type 1 diabetes due to the request for additional time to review further clinical data [5] Group 1 - The FDA has requested additional time for the review of the marketing application for Zynquista [5] - The request for more time is related to the submission of additional clinical data [5]

Core Insights - Lexicon Pharmaceuticals is working on resubmitting the New Drug Application (NDA) for Zynquista (sotagliflozin) to the FDA, following a complete response letter issued in December 2024 due to concerns about diabetic ketoacidosis risk [1][2] - The company has submitted additional clinical data from ongoing studies to support the benefit-risk profile of Zynquista in adults with type 1 diabetes (T1D) [2] - Feedback from the FDA is now expected in the fourth quarter of 2025, later than the previously anticipated end of September timeline [1] Group 1 - The FDA's complete response letter in December 2024 raised concerns about the increased risk of diabetic ketoacidosis associated with Zynquista [2] - Lexicon has conducted three ongoing studies to support the resubmission: STENO1, SUGARNSALT, and SOPHIST, which involve approximately 20,000 patients [2][3] - Sotagliflozin is an oral SGLT1/SGLT2 inhibitor aimed at improving glycemic control in adults with T1D [1][3] Group 2 - Lexicon Pharmaceuticals utilizes a unique genomics target discovery platform, Genome5000™, to identify therapeutic protein targets [5] - The company has a diverse pipeline of drug candidates in various stages of development, including treatments for neuropathic pain, hypertrophic cardiomyopathy, and obesity [5] - Lexicon's mission is to pioneer innovative medicines that transform patients' lives through precise targeting of proteins [5]

Core Insights - Lexicon Pharmaceuticals presented clinical data from the Phase 2b PROGRESS study for pilavapadin, an AAK1-inhibitor for diabetic peripheral neuropathic pain (DPNP), showing a two-point reduction in average daily pain scores by week 11 [1][3] - Pilavapadin has the potential to be the first non-opioid oral medication approved for DPNP in over two decades, with the company looking forward to Phase 3 trials [2][5] Study Results - The PROGRESS study evaluated once daily doses of pilavapadin (10 mg, 20 mg) in adults with DPNP, identifying 10 mg as the most clinically meaningful dose [2][3] - A post-hoc analysis indicated significant separation from placebo for the 10 mg dose, with a clinically meaningful reduction in pain scores observed [3] - The 10 mg dose was well tolerated, with minimal discontinuations reported [3] Disease Context - DPNP is a common and debilitating complication of diabetes, affecting approximately 30% of type 1 diabetes patients and 50% of type 2 diabetes patients, with around nine million patients in the U.S. suffering from this condition [4] - There is a significant need for new non-opioid treatments for DPNP, as current options are limited [4] About Pilavapadin - Pilavapadin (LX9211) is a selective, investigational small molecule that inhibits AAK1, targeting neuropathic pain without affecting opiate pathways [6] - Preclinical studies have shown its effectiveness in reducing pain behavior while penetrating the central nervous system [6] About the PROGRESS Study - The PROGRESS study began in December 2023, enrolling 496 adult patients with moderate to severe DPNP, and was designed to evaluate the efficacy of pilavapadin against placebo [7][8] Company Overview - Lexicon Pharmaceuticals focuses on pioneering medicines through its Genome5000™ program, identifying therapeutic targets for various diseases, including neuropathic pain [9]

Core Insights - Lexicon Pharmaceuticals is presenting clinical data for pilavapadin, an investigational AAK1-inhibitor aimed at treating diabetic peripheral neuropathic pain (DPNP) at multiple medical meetings [1][5][6] Group 1: Clinical Data and Presentations - The clinical data will be discussed at three upcoming medical meetings: NeuroDiab in Bucharest, EASD in Vienna, and Arrowhead's Annual Pain Therapeutics Summit in San Diego [2][3][4] - A specific presentation titled "New Promise for Painful Diabetic Neuropathy" will take place on September 13, 2025, by Dr. Rodica Pop-Busui [7] - The Phase 2b study results will be presented on September 17, 2025, also by Dr. Rodica Pop-Busui, focusing on pilavapadin's efficacy in DPNP [7] Group 2: Product Information - Pilavapadin (LX9211) is a once-daily, orally delivered, selective small molecule inhibitor of AAK1, which targets neuropathic pain without affecting opiate pathways [5] - Preclinical studies indicate that pilavapadin penetrates the central nervous system and reduces pain behavior in neuropathic pain models [5] Group 3: Company Overview - Lexicon Pharmaceuticals is focused on pioneering medicines that transform patients' lives, utilizing its Genome5000™ program to identify therapeutic protein targets [6] - The company has a pipeline of drug candidates in various stages of discovery and development, addressing multiple indications including neuropathic pain and metabolic disorders [8]

Lexicon Pharmaceuticals FY Conference Summary Company Overview - **Company**: Lexicon Pharmaceuticals (NasdaqGS:LXRX) - **Industry**: Biopharmaceuticals, focusing on cardiovascular medicine and associated disorders [1] Core Points and Arguments 1. **R&D Focus and Progress**: Lexicon has pivoted its efforts to focus on its R&D pipeline, achieving significant progress in the first two-thirds of the year, including completing the phase 2 program for pilibapadin [2][3] 2. **Pilibapadin Development**: - Lead indication is diabetic peripheral neuropathic pain (DPNP) - Positive phase 2 data has been obtained, and an end-of-phase-2 meeting with the FDA is planned [4][9] - The drug shows great biological activity and a favorable safety profile, with a 10 mg dose selected for phase 3 trials [7][8] 3. **Sotagliflozin for Heart Failure**: - Ongoing phase 3 SONATA trial for hypertrophic cardiomyopathy (HCM) with data expected to be fully enrolled by 2026 [4][12] - The drug is positioned as a potential first-line treatment for HCM, addressing a significant unmet need in the market [13][14] - Current first-line treatments, such as beta blockers, have shown limited efficacy and potential harm [14] 4. **Partnerships and Licensing**: - Lexicon has partnered with Novo Nordisk for LX9851, focusing on obesity and related conditions, and has licensed ex-U.S. and ex-EU rights to Vieitrace [5][6] - Discussions for pilibapadin partnering are ongoing, with a flexible approach to deal structures [6][10] 5. **Zynquista in Type 1 Diabetes**: - The FDA has encouraged further studies for Zynquista, recognizing its efficacy and the unmet need in type 1 diabetes [19][23] - Lexicon is not investing further in Zynquista but will continue to pursue investigator-sponsored studies [20] Additional Important Content 1. **Clinical Trial Design**: The design of the phase 3 trials for DPNP will be simplified to two arms (placebo and active), which is expected to reduce variability and improve success likelihood [25][26] 2. **Market Opportunity**: There is a significant opportunity for sotagliflozin in both HCM and heart failure with preserved ejection fraction (HFpEF), as they present similarly in clinical settings [16][17] 3. **Upcoming Data Presentations**: Lexicon plans to present comprehensive data from its phase 2 platform at various conferences in September and October, which will bolster confidence in pilibapadin's phase 3 progression [11][12] 4. **Patient Perspective**: Insights from Pain Week highlighted the demand for new non-opioid oral medications for neuropathic pain, emphasizing the importance of innovation in this area [11] This summary encapsulates the key developments and strategic directions of Lexicon Pharmaceuticals as discussed in the conference, highlighting their focus on advancing their drug pipeline and addressing significant unmet medical needs in cardiovascular and metabolic diseases.