Lexicon Pharmaceuticals Inc Stock Price, News & Analysis

Lexicon Pharmaceuticals (Nasdaq: LXRX) has scheduled the release of its fourth quarter and full year 2024 financial results for Thursday, March 6, 2025, after market close. The company will host a conference call and live webcast at 5:00 p.m. ET (4:00 p.m. CT) on the same day to discuss the financial performance and provide a business update.

Investors can access the conference call through the Events page on Lexicon's investor website. Those interested in asking questions during the call can register to receive dial-in information and a unique PIN. An archived version of the webcast will be available for later viewing on the company's website.

Lexicon Pharmaceuticals (LXRX) has announced topline results from its Phase 2b PROGRESS study evaluating pilavapadin (LX9211), an oral non-opioid treatment for diabetic peripheral neuropathic pain (DPNP). The study achieved its objectives with the 10 mg dose, showing meaningful pain reduction versus placebo and improved tolerability.

The 10 mg dose demonstrated a reduction of 1.74 in mean average daily pain score (ADPS) compared to 1.31 in placebo. While the study's primary endpoint did not reach statistical significance (p=0.11), the 10 mg dose showed early and sustained clinically meaningful separation from placebo. Adverse events, primarily dizziness and nausea, were mild to moderate and significantly improved compared to the previous RELIEF-DPN-1 study.

Based on these results, Lexicon plans to advance the 10 mg dose into Phase 3 development, positioning pilavapadin to potentially become the first oral non-opioid treatment approved for neuropathic pain in 20 years.

Lexicon Pharmaceuticals (LXRX) has scheduled a conference call and webcast for March 3, 2025, at 8:00 a.m. ET to present topline results from their Phase 2b PROGRESS study. The study evaluates pilavapadin (LX9211), an oral, non-opioid investigational drug that inhibits adaptor-associated kinase 1 (AAK1), for treating moderate to severe diabetic peripheral neuropathic pain (DPNP) in adults.

The PROGRESS trial is designed as a dose-ranging, randomized, double-blind, placebo-controlled, parallel-group, multicenter study with an open-label extension. Interested participants can access the live conference call and webcast through the company's investor relations website, with an archived version to be made available afterward.

Lexicon Pharmaceuticals (Nasdaq: LXRX) announced that The Lancet Diabetes & Endocrinology published a study highlighting the unique efficacy of sotagliflozin in reducing major adverse cardiovascular events (MACE). The study, a secondary analysis of the SCORED randomized trial, demonstrated that sotagliflozin, a dual SGLT1 and SGLT2 inhibitor, significantly reduced the risk of heart attack (MI) and stroke in patients with type 2 diabetes (T2D), chronic kidney disease (CKD), and high cardiovascular (CV) risk.

Patients on sotagliflozin had a lower rate of MACE outcomes (4.8 events per 100 person-years [p-y]) compared to placebo (6.3 events per 100 p-y) with a hazard ratio (HR) of 0.77, 95% confidence interval (CI) of 0.65-0.91, and P=0.002. The drug also reduced the rate of MI (1.8 events per 100 p-y vs. 2.7 events per 100 p-y, HR: 0.68, 95% CI: 0.52-0.89, P=0.004) and stroke (1.2 events per 100 p-y vs. 1.8 events per 100 p-y, HR: 0.66, 95% CI: 0.48-0.91, P=0.012).

Dr. Deepak L. Bhatt, Director at Mount Sinai Fuster Heart Hospital, emphasized that sotagliflozin is the only SGLT inhibitor to show significant reductions in both heart attack and stroke.

Lexicon Pharmaceuticals (LXRX) announced a virtual webcast titled 'LX9211 - Changing the Paradigm for Treatment of Neuropathic Pain' scheduled for January 28, 2025, from 9:00 a.m. to 11:00 a.m. ET. The event precedes the anticipated topline data release from the Phase 2b PROGRESS trial later this quarter.

The webcast will feature presentations from Lexicon's leadership team, including CEO Mike Exton, VP of Clinical Development Suma Gopinathan, and Chief Medical Officer Craig Granowitz. The event will also include an expert panel discussion on diabetic peripheral neuropathic pain (DPNP) with renowned specialists Dr. Rodica Pop-Busui and Dr. Steve Edelman.

LX9211 is Lexicon's novel, investigational, non-opioid treatment for DPNP. The event will be available in the 'Events' section of Lexicon's website, with a recording accessible after the live broadcast.

Lexicon Pharmaceuticals (LXRX) has appointed Scott Coiante as senior vice president and chief financial officer, effective January 2, 2025. Coiante brings over 35 years of experience in life science and pharmaceutical industries. He previously served as SVP, CFO, and treasurer at Agile Therapeutics from August 2023 to August 2024 and from 2011-2019, where he managed all financial activities including business development and fundraising.

Prior to joining Lexicon, Coiante held positions as SVP, CFO, treasurer, and secretary at Aprea Therapeutics and various senior financial roles at Medarex Inc, supporting its transition after acquisition by Bristol-Myers Squibb. The appointment aligns with Lexicon's strategic shift towards high-impact therapeutic areas and their Lead to Succeed strategy.

Lexicon Pharmaceuticals (LXRX) has received a Complete Response Letter (CRL) from the FDA regarding its New Drug Application for Zynquista™ (sotagliflozin). The drug was intended as an adjunct to insulin therapy for glycemic control in adults with type 1 diabetes and chronic kidney disease (CKD). This decision was anticipated, aligning with Lexicon's previous strategic decision to discontinue Zynquista launch preparations and focus on its clinical development pipeline. The company is now prioritizing LX9211 for diabetic neuropathic pain, with top-line data from the PROGRESS Phase 2b study expected in Q1 2025.

Lexicon Pharmaceuticals announced the completion of patient enrollment in the PROGRESS Phase 2B study evaluating LX9211 for diabetic peripheral neuropathic pain (DPNP). The study exceeded its enrollment target by 20%, successfully recruiting 494 patients, and finished eight weeks ahead of schedule. LX9211 is a novel, oral selective investigational small molecule inhibitor of adaptor-associated kinase 1 (AAK1). The strong interest in trial participation demonstrates significant demand for new non-opioid DPNP treatments. Top-line data is expected in Q1 2025.

Lexicon Pharmaceuticals (Nasdaq: LXRX) has announced its participation in two major investor conferences this December. CEO Mike Exton will present at the Piper Sandler 36th Annual Healthcare Conference on Tuesday, December 3, 2024, at 8:00 am ET, and the 7th Annual Evercore HealthCONx Conference on Thursday, December 5, 2024, at 12:30 pm ET.

Live webcasts of both presentations will be accessible through the Events section of Lexicon's website, with recordings available for two weeks after the original broadcasts.