Lexicon Pharmaceuticals Inc Stock Price, News & Analysis

Lexicon Pharmaceuticals (Nasdaq: LXRX) presented additional Phase 2 pilavapadin data for diabetic peripheral neuropathic pain (DPNP) on Oct 14, 2025. Analyses support advancing a 10 mg once-daily dose into Phase 3 and a U.S. FDA end-of-Phase 2 meeting request has been accepted.

The pooled post-hoc analysis covered >600 patients from RELIEF-DPN 1 and PROGRESS, reported a 2-point average daily pain score (ADPS) reduction at 12 weeks for 10 mg, showed a linear exposure-response relationship, found an acceptable safety and tolerability profile, and noted lower adherence and increased tolerability symptoms in the PROGRESS 20 mg arm. A slide deck is available on the company events page.

Lexicon Pharmaceuticals (NASDAQ: LXRX) convened a stakeholder roundtable on Oct 8, 2025 at BIO headquarters to discuss public policy gaps for people with chronic pain and options to expand the Alternatives to PAIN Act to include chronic pain.

Participants included clinicians, patient advocates, and individuals affected by pain. The meeting cited U.S. Pain Foundation estimates of ~50 million Americans with chronic pain and costs of up to $635 million annually. Lexicon said it will publish a White Paper summarizing the roundtable outcomes and advocated for broader Medicare Part D access to non-opioid therapies beyond acute and post‑surgical pain.

Lexicon Pharmaceuticals (NASDAQ:LXRX) has provided an update regarding its New Drug Application (NDA) for Zynquista® (sotagliflozin), an oral SGLT1/SGLT2 inhibitor for type 1 diabetes treatment. The company has submitted additional clinical data to the FDA from three ongoing third-party funded studies conducted at Steno Diabetes Center, Joslin Diabetes Center, and University of Dundee to address concerns about diabetic ketoacidosis risk raised in a December 2024 complete response letter.

The FDA has indicated it needs more time to review the new data and will now provide feedback from the September Type D meeting in Q4 2025, later than the previously expected end-of-September timeline. The studies aim to support Zynquista's benefit-risk profile as an adjunct to insulin for glycemic control in adults with type 1 diabetes.

Lexicon Pharmaceuticals (NASDAQ:LXRX) presented promising clinical data for pilavapadin, its investigational AAK1-inhibitor for diabetic peripheral neuropathic pain (DPNP), at two major medical conferences. The Phase 2b PROGRESS study demonstrated that pilavapadin 10 mg achieved a significant two-point reduction in average daily pain scores by week 11.

The study evaluated various dosing regimens, with the 10 mg daily dose emerging as the most clinically meaningful option, showing nominally significant separation from placebo (p < 0.05). The treatment was well-tolerated with minimal discontinuations. Pilavapadin could become the first non-opioid, oral medication approved for DPNP in over 20 years, addressing a significant market of approximately 9 million U.S. patients.

Lexicon Pharmaceuticals (NASDAQ:LXRX) announced upcoming presentations of clinical data for pilavapadin, their investigational AAK1-inhibitor for treating diabetic peripheral neuropathic pain (DPNP), at three major medical meetings.

The presentations will take place at NeuroDiab (September 11-14, Romania), the European Association for the Study of Diabetes (EASD) (September 16-19, Austria), and Arrowhead's 19th Annual Pain Therapeutics Summit (October 13-14, California). Key data from the Phase 2b PROGRESS trial and pilavapadin's potential as a non-opioid treatment option will be discussed by prominent medical experts.

Lexicon Pharmaceuticals (NASDAQ:LXRX) has submitted additional clinical data to the FDA supporting the potential resubmission of Zynquista's New Drug Application (NDA). The submission aims to address concerns raised in a December 2024 complete response letter regarding increased diabetic ketoacidosis risk in type 1 diabetes patients.

The new data comes from three ongoing third-party funded, investigator-initiated studies conducted by Steno Diabetes Center, Joslin Diabetes Center, and the University of Dundee. The company has been granted a Type D meeting with the FDA, with feedback expected by the end of September 2025.

Lexicon Pharmaceuticals (NASDAQ:LXRX) announced it will present new preclinical data for pilavapadin at the NeuPSIG 2025 conference in Berlin. The research demonstrates the drug's effectiveness in reducing neuropathic pain in preclinical models of chemotherapy-induced peripheral neuropathy (CIPN) and multiple sclerosis (MS).

The findings emphasize the importance of inhibiting pilavapadin's novel target, AAK1, for pain signaling modulation. The company will also present a poster on the study design of PROGRESS, a Phase 2b dose-ranging study of pilavapadin in diabetic peripheral neuropathic pain (DPNP). The presentations suggest potential expansion of pilavapadin's applications beyond its current focus on DPNP.

Lexicon Pharmaceuticals (Nasdaq: LXRX) will present data at PAINWeek 2025 regarding the impact of diabetic peripheral neuropathic pain (DPNP) on patients. The presentation, scheduled for September 4, 2025, will showcase insights from a patient survey related to the development of Pilavapadin.

The study focuses on patients' experiences with DPNP despite using current pain relief options. The presentation highlights that diabetic neuropathy affects nearly 50% of diabetes patients during their lifetime, with 25-30% suffering from DPNP specifically, characterized by burning, tingling, and numbness that significantly impacts quality of life.

Lexicon Pharmaceuticals (NASDAQ:LXRX) presented compelling post-hoc analysis results for sotagliflozin at the ESC 2025 Congress in Madrid. The analysis, pooling data from SCORED and SOLOIST-WHF trials with nearly 12,000 participants, demonstrated consistent cardiovascular benefits across all age groups.

The study showed sotagliflozin, a dual SGLT-1 and SGLT-2 inhibitor, reduced heart failure endpoints and major cardiovascular events regardless of age. Key findings include reduction in cardiovascular death and heart failure hospitalization (8.5 vs 11.8 events/100 person-years) and decreased MACE events (5.7 vs 7.1 events/100 person-years). The drug showed particular efficacy in patients over 65, who represented 70% of the study population.