Lexicon Pharmaceuticals

Lexicon Pharmaceuticals, Inc. engages in the discovery, development, and commercialization of pharmaceutical products for the treatment of human disease. Its drug candidates include: LX9211, an orally-delivered small molecule drug candidate, as a treatment for neuropathic pain, and Sotagliflozin, a treatment for heart failure and type 1 diabetes. The company was founded by Brian P. Zambrowicz and Arthur T. Sands on July 7, 1995 and is headquartered in The Woodlands, TX.

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Lexicon Pharmaceuticals reports strong Q4 performance and eyes growth

Lexicon Pharmaceuticals showcased promising drug candidates and financial stability in Q4 2022.
While facing challenges in revenue generation and expense management, the company is strategically positioned for growth.
Opportunities lie in commercial launches, Phase 3 advancements, and potential partnerships to drive future success.
Overall, Lexicon's focus on maximizing asset value and advancing key drugs positions them for long-term success in the pharmaceutical market.

Lexicon Pharmaceuticals reports robust Q1 performance and eyes market expansion

Lexicon Pharmaceuticals showcased strong financials, promising drug candidates, and strategic confidence in market success.
Challenges lie in market penetration strategies, FDA feedback, and successful commercialization amidst competition.
Opportunities abound with upcoming sotagliflozin launch, advancing LX9211, and leveraging unique data for growth.

Lexicon Pharmaceuticals reports strong Q2 earnings and advances key treatments

Lexicon Pharmaceuticals demonstrated financial stability and strategic progress in Q2 2023, supported by strong cash reserves and key regulatory milestones.
The company's focus on patient-centric initiatives and upcoming product launches positions it for sustained growth and market success.
Challenges in market penetration and revenue realization require targeted strategies, while opportunities in market expansion and pipeline development offer avenues for growth.
Overall, Lexicon Pharmaceuticals shows promise with a solid foundation for future success, driven by innovation and market-focused strategies.

Lexicon Pharmaceuticals reports Q3 loss, highlights INPEFA progress and global expansion

Lexicon Pharmaceuticals faces challenges in market access and inventory trends while capitalizing on opportunities through geographic expansion and potential partnerships. The company's financial performance in Q3 2023 showed increased expenses but progress in prescription demand for INPEFA.

Lexicon Pharmaceuticals reports strong Q1 performance and growth opportunities

Lexicon Pharmaceuticals showcased strong performance and progress in Q1 2024, with a focus on product launches and market access.
Despite challenges in achieving full access and addressing specific patient needs, the company remains optimistic about future growth opportunities.
Positive customer feedback, ongoing pipeline advancements, and strategic market considerations position Lexicon well for future success and sales acceleration.

Lexicon Pharmaceuticals reports Q3 progress amidst financial challenges and opportunities

Lexicon Pharmaceuticals showcased progress in key development programs and strategic partnerships in Q3 2024.
Despite financial challenges, the company's operational strengths and focus on growth opportunities are notable.
Navigating uncertainties around ZYNQUISTA and competition in the market are key challenges ahead.
Overall, the company's performance, strengths, challenges, and opportunities shape its strategic outlook for future growth.

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The U.S. Food and Drug Administration declined to approve Lexicon Pharmaceuticals' add-on drug for type 1 diabetes and chronic kidney disease, the company said on Friday.

US FDA declines to approve Lexicon Pharma's add-on diabetes drug

THE WOODLANDS, Texas, Dec. 20, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced it has received a complete response letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for Zynquista™ (sotagliflozin) as an adjunct to insulin therapy for glycemic control in adults with type 1 diabetes and chronic kidney disease (CKD). This expected communication from the FDA aligns with the company's previously disclosed strategic decision to discontinue launch preparations for Zynquista and focus solely on its clinical development pipeline.

Lexicon Announces Receipt of Complete Response Letter for Zynquista™ (sotagliflozin)

Strong Interest in Trial Participation Resulted in Enrollment Exceeding Target by 20 Percent and Completion Ahead of Schedule

Lexicon Announces Completion of Enrollment in Phase 2B PROGRESS Study of LX9211 in Diabetic Peripheral Neuropathic Pain (DPNP)

THE WOODLANDS, Texas, Nov. 25, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that company management, including Mike Exton, Lexicon's chief executive officer and director, will present at two upcoming investor conferences in December.

Lexicon Pharmaceuticals to Participate in December Investor Conferences

Lexicon Pharmaceuticals said on Friday it would reduce its workforce by about 60%, effective Dec. 31, to eliminate commercial activities and focus on drug development.

Lexicon Pharmaceuticals to cut workforce by 60% to focus on drug development

Implementing Strategic Restructuring to Eliminate Commercial Organization and Rationalize Operations Across All Functions

Lexicon to Reposition as Clinical Development-Focused Company Following Regulatory Update From FDA

THE WOODLANDS, Texas, Nov. 20, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that Ivan H. Cheung has been elected to its Board of Directors.

Lexicon Appoints Ivan H. Cheung to Board of Directors

Start Time: 17:00 January 1, 0000 5:55 PM ET Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX ) Q3 2024 Earnings Call November 12, 2024, 17:00 PM ET Company Participants Mike Exton - CEO and Director Tom Garner - SVP and Chief Commercial Officer Craig Granowitz - SVP and Chief Medical Officer Alan Main - EVP, Innovation and Chemical Sciences Lisa DeFrancesco - Head, IR and Corporate Strategy Conference Call Participants Andrew Tsai - Jeffries Joseph Stringer - Needham and Company Joe Pantginis - H.C. Wainwright Yigal Nochomovitz - Citigroup Roanna Ruiz - Leerink Partners Operator Good day, and welcome to the Lexicon Pharmaceuticals Third Quarter 2024 Results Conference Call.

Lexicon Pharmaceuticals, Inc. (LXRX) Q3 2024 Earnings Call Transcript

Lexicon Pharmaceuticals (LXRX) came out with a quarterly loss of $0.18 per share versus the Zacks Consensus Estimate of a loss of $0.17. This compares to loss of $0.21 per share a year ago.

Lexicon Pharmaceuticals (LXRX) Reports Q3 Loss, Lags Revenue Estimates

Announced Exclusive Licensing Agreement with Viatris for Sotagliflozin in all Markets Outside of the U.S. and Europe

Lexicon Pharmaceuticals Reports Third Quarter 2024 Financial Results and Provides Business Update

THE WOODLANDS, Texas, Nov. 06, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced its participation in the Jefferies London Global Healthcare Conference. Lexicon management including Mike Exton, Lexicon's chief executive officer and director will participate in a moderated discussion on Wednesday, November 20, 2024, at 9:00 am GT.

Lexicon Pharmaceuticals to Participate in the Jefferies London Global Healthcare Conference

People with T1D and CKD treated with sotagliflozin and insulin had similar lowering effects on glycated hemoglobin (HbA1c), the primary endpoint, as people with T1D who do not have CKD

Published Data in Journal of American Society of Nephrology Highlights Findings on Efficacy and Safety of Sotagliflozin for People With Type 1 Diabetes and Chronic Kidney Disease

THE WOODLANDS, Texas, Oct. 31, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced the outcome of the U.S. Food and Drug Administration (FDA) Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) Meeting to review the company's New Drug Application (NDA) for Zynquista (sotagliflozin), an oral SGLT1/SGLT2 inhibitor, as an adjunct to insulin therapy for glycemic control in adults with type 1 diabetes (T1D) and chronic kidney disease (CKD). The Advisory Committee voted 11 to 3 that the benefits of Zynquista do not outweigh the risks in adults with T1D and CKD, as defined in the voting question as having estimated glomerular filtration rate (eGFR) > 45 to 60 mL/min/1.73 m2 and urine albumin-to-creatinine ratio (uACR) > 30mg/g.

Lexicon Announces Outcome of FDA Advisory Committee for Zynquista™ (sotagliflozin) as an Adjunct to Insulin Therapy for Glycemic Control in Adults with Type 1 Diabetes and Chronic Kidney Disease

Independent advisers to the U.S. Food and Drug Administration on Thursday voted against recommending Lexicon Pharmaceuticals' add-on treatment to insulin therapy for managing blood glucose levels in adults with type 1 diabetes and chronic kidney disease.

FDA advisers vote against Lexicon Pharma's add-on drug for type 1 diabetes

-Lexicon to receive an upfront payment of $25 million and the potential for contingent regulatory and commercial milestone payments -Lexicon to receive an upfront payment of $25 million and the potential for contingent regulatory and commercial milestone payments

Lexicon Announces Exclusive Licensing Agreement With Viatris for Sotagliflozin in All Markets Outside of the U.S. and Europe

Viatris

Continues to Expand Viatris' Innovative Portfolio in Cardiovascular Diseases Leverages Viatris' Unique Global Infrastructure and Expertise Includes Opportunities to Leverage the Potential of Sotagliflozin to Additional Indications PITTSBURGH , Oct. 16, 2024 /PRNewswire/ -- Viatris Inc. (Nasdaq: VTRS), a global healthcare company, today announced it has entered into an exclusive licensing agreement with Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) for sotagliflozin in all markets outside of the United States and Europe. Sotagliflozin was approved by the U.S. Food and Drug Administration in May 2023 to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with heart failure or type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors.

Viatris Announces Exclusive Licensing Agreement with Lexicon Pharmaceuticals for Sotagliflozin in all Markets Outside of the U.S. and Europe

Patient randomization is underway in SONATA-HCM clinical trial evaluating Lexicon's novel dual SGLT1 and SGLT2 inhibitor in this underserved and growing patient population

Lexicon to Present Phase 3 Trial Design for Sotagliflozin in Hypertrophic Cardiomyopathy (HCM) at Upcoming Medical Congress

THE WOODLANDS, Texas, Sept. 16, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that Jeff Wade, president and chief operating officer, has decided to step down to pursue new opportunities outside of Lexicon, effective September 30, 2024. A search for a new chief financial officer is ongoing.

Lexicon Pharmaceuticals Announces Departure of President and Chief Operating Officer

Study results aligned with positive clinical trial outcomes for type 1 diabetes treatment with sotagliflozin

New Secondary Analysis of Phase 3 Data Demonstrates Sotagliflozin Improves Time-In-Range (TIR) and Several Parameters of Glucose Control and Variability in Basal Insulin-Treated Type 2 Diabetes

THE WOODLANDS, Texas, Sept. 03, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that Lexicon management will participate in the following investor conferences taking place in September:

Lexicon Pharmaceuticals to Participate in Upcoming September Investor Conferences

The FDA plans to hold an Advisory Committee meeting to give a recommendation for Lexicon's (LXRX) Zynquista (sotagliflozin) on Oct 31, 2024. Stock up.

Lexicon (LXRX) Up as FDA Maintains Action Date for Zynquista

Lexicon (LXRX) announces a portfolio reprioritization plan to focus on reducing operational expenses and driving the growth of the commercial portfolio. Shares rise.

Lexicon (LXRX) to Reprioritize Portfolio, Slash Jobs, Stock Up

Company to Focus on Targeted Promotion of INPEFA® in Heart Failure While Prioritizing Investment in the Potential Launch of ZYNQUISTA™

Lexicon Pharmaceuticals Announces Strategic Repositioning to Drive Value and Growth of Commercial Portfolio

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.

Efficacy and Safety Data of Sotagliflozin in Patients with Type 1 Diabetes and Chronic Kidney Disease Among Three Lexicon-Sponsored Presentations at the 2024 Annual Conference of the Association of Diabetes Care & Education Specialists

Lexicon Pharmaceuticals' launch of Inpefa continues to progress very slowly; prescriptions grew nearly 50% QoQ, but revenue is still below $2M and missing sell-side expectations. New leadership and cash reserves provide opportunities for Lexicon to improve commercial execution and drive revenue growth, and improved patient access and payer coverage are 2H'24 priorities. The company has resubmitted its application for Zynquista in Type 1 diabetes, a commercially significant opportunity, but one where regulatory and execution risk are still very present.

News for Lexicon Pharmaceuticals Stock (LXRX)