Lexicon Pharmaceuticals, Inc. - LXRX STOCK NEWS

Lexicon Pharmaceuticals (LXRX) has resubmitted a New Drug Application (NDA) to the FDA for sotagliflozin, targeting heart failure treatment. The NDA, based on the SOLOIST-WHF and SCORED Phase 3 trials, aims to address significant medical needs. The FDA will review the submission within a 60-day period to decide on its completeness. The trials demonstrated the efficacy of sotagliflozin, achieving their primary endpoints, which involved reductions in cardiovascular events among patients with diabetes and heart failure.

Lexicon Pharmaceuticals (Nasdaq: LXRX) reported Q1 2022 financial results, showing a net loss of $23.5 million, or $0.16 per share, compared to a loss of $21.0 million, or $0.15 per share in Q1 2021. The company plans to resubmit its New Drug Application for sotagliflozin for heart failure treatment, supported by a $150 million loan facility. Significant reductions in major adverse cardiovascular events were noted in sotagliflozin trials. Top-line results for LX9211 studies are expected this year.

Lexicon Pharmaceuticals (Nasdaq: LXRX) will announce its Q1 2022 financial results on May 5, 2022, prior to market opening. A conference call will follow at 8:00 a.m. ET for discussing the results and offering a business update. Lexicon focuses on innovative medicines targeting over 100 therapeutic proteins identified through its Genome5000™ program. The company has progressed one drug to market and has a pipeline in various stages of development for conditions including heart failure and diabetes.

Lexicon Pharmaceuticals announced that Jeffrey L. Wade, President and CFO, will present at the 21st Annual Needham Virtual Healthcare Conference on April 12, 2022, at 8:45 a.m. ET. The event will be available via webcast on Lexicon's website, with an archived version accessible for two weeks post-event.

Lexicon focuses on pioneering medicines through its Genome5000™ program, identifying therapeutic targets across various diseases. The company has one medicine on the market and a pipeline in clinical and preclinical stages, including treatments for heart failure, neuropathic pain, and diabetes.

Lexicon Pharmaceuticals (LXRX) welcomes new heart failure management guidelines from the AHA, ACC, and HFSA. The guidelines recommend SGLT2 inhibitors as a first-line treatment for heart failure (HF) across various categories, strengthening the therapeutic landscape for this condition. Notably, they highlight the need for improved medical therapy optimization during hospitalizations. Lexicon's sotagliflozin is recognized for its unique mechanism, with clinical trials validating its efficacy. The guidelines replace earlier standards and are expected to boost SGLT2 inhibitor adoption.

Lexicon Pharmaceuticals announced significant findings from the SCORED Phase 3 clinical trial for sotagliflozin, presented at the American College of Cardiology’s 71st Annual Scientific Session. The analysis, involving 10,584 patients with type 2 diabetes and chronic kidney disease, revealed a 21% reduction in major adverse cardiovascular events (MACE) in patients with cardiovascular disease and a 26% reduction in those without. The results underscore sotagliflozin's potential in reducing cardiovascular death, myocardial infarction, and stroke, reinforcing its therapeutic significance.

Lexicon Pharmaceuticals (Nasdaq: LXRX) announced a late-breaking presentation at the American College of Cardiology’s 71st Annual Scientific Session. Dr. Deepak L. Bhatt will present a secondary analysis of sotagliflozin data from the SCORED Phase 3 trial on April 2, 2022. The analysis will focus on the reduction of cardiovascular death, myocardial infarction, and stroke. Sotagliflozin is approved in the EU for type 1 diabetes. Despite its approval, commercial launch in the U.S. is pending. For more details, visit Lexicon's website.

Lexicon Pharmaceuticals (Nasdaq: LXRX) has secured a loan facility with Oxford Finance LLC, offering up to $150 million to fund commercial preparations and the potential launch of sotagliflozin for heart failure. The agreement includes four tranches, with an initial $25 million funded at closing. Additional funds are contingent upon regulatory approval from the FDA. The loan carries a floating interest rate starting at 8.01%. Lexicon also granted warrants for 420,673 shares to Oxford, exercisable through 2027, providing a financial flexibility as the company approaches important regulatory milestones.

Lexicon Pharmaceuticals (Nasdaq: LXRX) announced its financial results for Q4 and full-year 2021, reporting negligible revenues due to the sale of its XERMELO product in 2020. R&D expenses surged to $16.5 million in Q4 2021, reflecting increased costs for LX9211 studies, while SG&A expenses rose to $8.8 million. The company's net loss for Q4 was $25.6 million, compared to $5.5 million in Q4 2020, totaling a net loss of $87.8 million for 2021. Lexicon also voluntarily withdrew its NDA for sotagliflozin to correct a technical issue, with plans to resubmit in Q2 2022.