Welcome to our dedicated page for Lexicon Pharmaceuticals news (Ticker: LXRX), a resource for investors and traders seeking the latest updates and insights on Lexicon Pharmaceuticals stock.
Lexicon Pharmaceuticals, Inc. (symbol: LXRX) is a biopharmaceutical company dedicated to the discovery, development, and commercialization of innovative drugs to treat serious human diseases. Utilizing advanced genetics, Lexicon has developed a robust pipeline of novel drug candidates aimed at addressing a wide range of medical needs.
Research and Development: Lexicon's research team employs gene knockout technology to investigate thousands of potential drug targets in the human genome. This approach has enabled the company to gain a deep understanding of target biology, leading to the identification of new therapeutic interventions. Lexicon's systematic drug discovery process integrates recombinant DNA and chemistry technologies, allowing for the effective evaluation and advancement of promising drug candidates.
Key Products and Pipeline: Among Lexicon's notable drug candidates are LX9211, an orally delivered small molecule for neuropathic pain, and sotagliflozin (marketed as INPEFA®), another orally delivered small molecule for heart failure and type 1 diabetes. Sotagliflozin is a dual inhibitor of SGLT2 and SGLT1, proteins responsible for glucose regulation. The drug has demonstrated efficacy in clinical trials involving around 20,000 patients across multiple conditions, including diabetes and chronic kidney disease.
Recent Achievements: Lexicon has successfully launched INPEFA® in the United States, marking a significant milestone in its commercialization efforts. The company continues to advance its other drug candidates through clinical and preclinical development, with a focus on neuropathic pain, diabetes, metabolism, and other therapeutic areas.
Financial Condition: As of the latest reports, Lexicon's research and development expenses have increased, reflecting its commitment to advancing its pipeline. The company is actively engaged in investor and media relations, providing regular updates on its financial position, strategic alliances, and regulatory progress.
Partnerships and Strategic Alliances: Lexicon's unique expertise in genomics has attracted several strategic partnerships aimed at enhancing its drug discovery and development capabilities. These alliances support the company's mission to pioneer medicines that transform patients' lives.
For more detailed information about Lexicon Pharmaceuticals and its latest developments, visit their official website.
Lexicon Pharmaceuticals (Nasdaq: LXRX) has announced the completion of screening for its Phase 2B PROGRESS study of LX9211 in Diabetic Peripheral Neuropathic Pain (DPNP). The company expects to complete enrollment ahead of schedule, with top-line data now anticipated in Q1 2025, earlier than the previously expected Q2 2025.
LX9211, an orally-delivered, potent, selective, investigational small molecule inhibitor of adaptor-associated kinase 1 (AAK1), has previously received Fast Track designation from the U.S. Food and Drug Administration (FDA) for DPNP. The PROGRESS study, which began in December 2023, aims to enroll adult patients with moderate to severe DPNP, allowing them to continue their current pain therapy. The primary endpoint is a reduction of Average Daily Pain Score (ADPS) at 8 weeks.
Viatris Inc. (Nasdaq: VTRS) has entered an exclusive licensing agreement with Lexicon Pharmaceuticals for sotagliflozin in all markets outside the U.S. and Europe. Sotagliflozin, approved by the FDA in May 2023, reduces cardiovascular risks in adults with heart failure or type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors.
This agreement leverages Viatris' expertise in cardiovascular diseases and its Global Healthcare Gateway®. Viatris will pay Lexicon an upfront payment of $25 million, with additional potential contingent payments including regulatory milestones, sales milestones, and tiered royalties ranging from low-double-digit to upper-teens on annual net sales. Viatris will handle regulatory and commercialization activities in licensed territories, while Lexicon will provide clinical and commercial supply of sotagliflozin.
Lexicon Pharmaceuticals (Nasdaq: LXRX) has announced the presentation of study design details for SONATA-HCM, a Phase 3 clinical trial evaluating sotagliflozin as a potential treatment for adults with hypertrophic cardiomyopathy (HCM). The presentation will take place at the virtual Hypertrophic Cardiomyopathy Medical Society (HCMS) 2024 Scientific Sessions.
The multinational study aims to enroll adults with symptomatic obstructive or non-obstructive HCM at 130 sites across 20 countries. Patient randomization has already begun. The trial design is intended to support a supplemental new drug application (sNDA) with a broad label for both HCM types. Experts highlight the significant unmet needs in HCM treatment and express optimism about sotagliflozin's potential efficacy in this patient population.
Lexicon Pharmaceuticals (Nasdaq: LXRX) announced that Jeff Wade, president and chief operating officer, will step down on September 30, 2024, to pursue new opportunities. Wade has served in various leadership roles at Lexicon for 25 years. The company is currently searching for a new chief financial officer. Lexicon's chairman and CEO expressed gratitude for Wade's contributions, highlighting his role in the potential approval of sotagliflozin for type 1 diabetes and CKD, and the development of LX9211 for diabetic peripheral neuropathic pain. The company remains confident in its current leadership team and future prospects, with several near-term and long-term catalysts expected to drive value.
Lexicon Pharmaceuticals (Nasdaq: LXRX) announced positive results from the SOTA-INS CGM Phase 3 trial for sotagliflozin in type 2 diabetes (T2D) patients treated with basal insulin. The study showed that once-daily dosing of sotagliflozin 400 mg improved time-in-range (TIR) and several continuous glucose monitoring (CGM) parameters, including glucose variability. The 200 mg dose also showed positive trends.
Key findings include:
- Sotagliflozin 200 mg and 400 mg once daily TIR (15.3 and 15.9 hours, respectively) approached the American Diabetes Association's target of 17 hours
- Modest reductions in time-above-range (TAR) and mild increases in time-below-range (TBR) were observed
The results will be presented at the 60th Annual Meeting of the European Association for the Study of Diabetes (EASD) on September 12th, 2024.
Lexicon Pharmaceuticals (Nasdaq: LXRX) has announced its participation in two upcoming investor conferences in September 2024. The company will be presenting at the H.C. Wainwright 26th Annual Global Investment Conference on Tuesday, September 10, at 12:30pm ET, and the 2024 Cantor Fitzgerald Global Healthcare Conference on Tuesday, September 17, at 8:35am ET.
Investors and interested parties can access live webcasts of these presentations through the 'Events' section of Lexicon's website at www.lexpharma.com/events. Recordings of the webcasts will remain available for two weeks following the original on-demand date, providing an opportunity for those unable to attend the live events to catch up on Lexicon's latest updates and strategic insights.
Lexicon Pharmaceuticals (Nasdaq: LXRX) announced new secondary analysis results from the Phase 3 SCORED trial for INPEFA® (sotagliflozin). The study showed that INPEFA reduced the risk of major adverse cardiovascular events (MACE) and heart failure (HF) events across all diabetes durations, with greater benefits for HF patients with longer diabetes duration.
Key findings include:
- INPEFA reduced primary endpoint events (5.6 vs 7.5 per 100 patient-years; HR: 0.74)
- MACE reduction: 4.8 vs 6.3 events per 100 patient-years (HR: 0.77)
- Increasing HF event reduction benefit with longer diabetes duration
- Results presented at the European Society of Cardiology Congress 2024
This analysis further differentiates INPEFA among SGLT inhibitors, highlighting its efficacy in reducing cardiovascular risks for heart failure patients, particularly those with longer diabetes duration.
Lexicon Pharmaceuticals (Nasdaq: LXRX) announced that the FDA will hold an advisory committee meeting on October 31, 2024, to review Zynquista™ (sotagliflozin) as an adjunct to insulin therapy for glycemic control in adults with type 1 diabetes and chronic kidney disease (CKD). The PDUFA goal date remains December 20, 2024. The FDA plans to make background materials public two business days before the meeting. Lexicon's CEO, Dr. Mike Exton, expressed enthusiasm about sharing evidence supporting Zynquista's favorable benefit/risk profile for the target patient group.
Lexicon Pharmaceuticals announces strategic repositioning to optimize its commercial portfolio and drive growth. The company will focus on targeted promotion of INPEFA® for heart failure while preparing for the potential launch of ZYNQUISTA™ for type 1 diabetes with chronic kidney disease. This restructuring is expected to reduce 2025 operating costs by $40 million.
Key actions include:
- Reducing headcount by over 75 (50% of field force) by Q3 2024
- Targeted promotion of INPEFA® in heart failure
- Investment in ZYNQUISTA™ launch preparation
- Continued funding for R&D programs, including Phase 3 study of sotagliflozin in hypertrophic cardiomyopathy and Phase 2b study of LX9211 in diabetic neuropathic pain
The company aims to create efficiencies while maintaining focus on high-impact opportunities for patients and shareholders.
Lexicon Pharmaceuticals (Nasdaq: LXRX) announced three poster presentations at the 2024 Annual Conference of the Association of Diabetes Care & Education Specialists. The presentations focus on:
1. Efficacy and safety of sotagliflozin in patients with Type 1 Diabetes and Chronic Kidney Disease
2. Impact of sotagliflozin as an add-on to basal insulin-treated Type 2 Diabetes
3. Patient-reported burden of disease in Diabetic Peripheral Neuropathic Pain
Dr. Craig Granowitz, Lexicon's CMO, highlighted the importance of the data on sotagliflozin's clinical effect in people with T1D and CKD, noting their high risk of kidney failure and cardiovascular events due to poor glycemic control.
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