Lexicon Pharmaceuticals, Inc. - LXRX STOCK NEWS

Lexicon Pharmaceuticals (LXRX) received an unfavorable vote from the FDA Advisory Committee regarding Zynquista, its oral SGLT1/SGLT2 inhibitor for type 1 diabetes (T1D) and chronic kidney disease (CKD) patients. The committee voted 11-3 against the drug's benefits outweighing its risks. Despite the negative outcome, some committee members expressed support for the drug in certain T1D and CKD sub-populations. The FDA's final decision is expected by December 20, 2024. Currently, only 20% of T1D patients achieve adequate glycemic control with insulin alone, highlighting the potential market need for Zynquista as the first oral medication for T1D patients.

Lexicon Pharmaceuticals announced a new analysis of its Phase 3 SCORED clinical trial demonstrating sotagliflozin's protective effects in patients with diabetic kidney disease (DKD). The post hoc analysis evaluated sotagliflozin's effect on Estimated Glomerular Filtration Rate (eGFR) slope versus placebo. Results showed a placebo-adjusted acute decline in eGFR of -2.59 ml/min/1.73m2/year across 10,574 participants. Notably, sotagliflozin demonstrated greater benefit on chronic slope with increasing baseline albuminuria. The findings will be presented at Kidney Week 2024 in San Diego.

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.