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) 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.
Lexicon Pharmaceuticals reported Q2 2024 financial results and provided a business update. Key highlights include:
- INPEFA (sotagliflozin) net sales of $1.6 million in Q2 2024
- Resubmitted NDA for ZYNQUISTA (sotagliflozin) in Type 1 Diabetes with PDUFA date of December 20, 2024
- Commenced SONATA Phase 3 study of sotagliflozin in Hypertrophic Cardiomyopathy (HCM)
- Expect topline data in Q2 2025 from PROGRESS Phase 2b study of LX9211 in Diabetic Peripheral Neuropathic Pain
Financial results: Revenues increased to $1.6 million, R&D expenses rose to $17.6 million, and SG&A expenses increased to $39.2 million. Net loss was $53.4 million or $0.17 per share. Cash and investments stood at $310.0 million as of June 30, 2024.
Lexicon Pharmaceuticals (Nasdaq: LXRX) has announced its upcoming second quarter 2024 financial results conference call and webcast, scheduled for August 1, 2024, after market close. The company will host a conference call and live webcast at 5:00 p.m. ET (4:00 p.m. CT) to discuss financial results and provide a business update.
Investors can access the call using the following details:
- U.S. Dial-in: (888) 317-6003
- International Dial-in: (412) 317-6061
- Conference ID: 7023126
Lexicon Pharmaceuticals (Nasdaq: LXRX) announced that the FDA has set a PDUFA goal date of December 20, 2024 for its resubmitted New Drug Application (NDA) for Zynquista™ (sotagliflozin). The drug is being evaluated as an adjunct to insulin therapy for glycemic control in adults with type 1 diabetes and chronic kidney disease (CKD). This resubmission is considered a complete response to the FDA's 2019 action letter.
Lexicon is actively preparing for a potential launch in early 2025. If approved, Zynquista would mark Lexicon's second NDA approval and commercial launch in two years of products originating from their novel discovery platform. The company expressed confidence in sotagliflozin's favorable benefit/risk profile for the target patient population.
Lexicon Pharmaceuticals (Nasdaq: LXRX) announced new data highlighting potential cost-savings of INPEFA® (sotagliflozin) for heart failure treatment. A study published in the Journal of Managed Care + Specialty Pharmacy showed significant financial benefits for hospitals using INPEFA in alternative payment models (APMs). The analysis, based on the SOLOIST-WHF trial, demonstrated that INPEFA reduced hospital readmissions and emergency visits, leading to larger bonus payments under APMs.
Key findings include:
- $4,720 margin increase per admission for the Hospital Readmissions Reduction Program
- $1,200 margin increase for Bundled Payments for Care Improvement-Advanced program
- $1,078 margin increase for Medicare Shared Savings Program
These results align with two other peer-reviewed studies from June 2024, further supporting INPEFA's clinical and financial advantages in heart failure treatment.
Lexicon Pharmaceuticals announced the appointment of Mike Exton, Ph.D., as its new CEO, effective July 8, 2024. Dr. Exton succeeds Lonnel Coats, who retired on July 7, 2024. Exton brings extensive experience from his 14-year tenure at Novartis, where he led the global cardiometabolic therapeutic area and played a key role in commercializing the world’s leading heart failure drug. He also has a strong background in research, development, and strategic acquisitions. Concurrently, Jeff Wade has been promoted to president and COO, having served as Lexicon's president and CFO since October 2021.
Lexicon Pharmaceuticals has resubmitted its New Drug Application (NDA) for sotagliflozin, aimed at improving glycemic control in people with type 1 diabetes and chronic kidney disease (CKD). This follows extensive interactions and recent feedback from the FDA. The company seeks approval for sotagliflozin as an adjunct to insulin therapy. Previously, the FDA issued a complete response letter (CRL) in 2019 regarding the NDA, and a Notice of Opportunity for Hearing (NOOH) was issued in 2021. Lexicon and the FDA agreed to hold NOOH proceedings in abeyance and explored a path for resubmission. The application holds a 'filed' status, with an anticipated six-month review and potential launch by early 2025.
Lexicon Pharmaceuticals announced that their Phase 2 RELIEF-DPN-1 clinical trial results for LX9211, an investigational non-opioid therapy for diabetic peripheral neuropathic pain (DPNP), were published in Diabetes Care. The study, conducted over 11 weeks, showed that LX9211 significantly reduced average daily pain scores in the low-dose group and was well tolerated by patients. The successful outcomes support the commencement of the Phase 2b PROGRESS trial, which is currently enrolling patients in the U.S.
Existing DPNP treatments often provide only modest pain relief and come with significant side effects. LX9211's promising results indicate it may offer a more effective and safer alternative for DPNP sufferers.
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