Lexicon Pharmaceuticals Inc Stock Price, News & Analysis

Lexicon Pharmaceuticals (Nasdaq: LXRX) reported new clinical data presented at AHA 2025 showing sotagliflozin produced statistically significant improvements in cardiac structure, diastolic function, six-minute walk distance and KCCQ scores in patients with preserved ejection fraction heart failure (HFpEF) without diabetes.

The prospective, randomized, double-blind, placebo-controlled SOTA P CARDIA trial enrolled 88 racially diverse participants (70% female) treated for six months. Peak VO2 improved but did not reach statistical significance. The company highlighted these results as the first demonstration of clinical benefit for HFpEF patients without diabetes.

Lexicon Pharmaceuticals (Nasdaq: LXRX) reported Q3 2025 results and R&D updates on Nov 6, 2025. Key financials: Q3 revenue $14.2M (vs $1.8M YoY) driven by a $45M upfront from Novo Nordisk and $1.0M INPEFA sales; net loss $12.8M or $0.04/share (vs $64.8M). Cash and investments were $145.0M at Sept 30, 2025.

Pipeline highlights: pilavapadin (LX9211) Phase 2b data support 10 mg dose and an FDA end-of-Phase 2 meeting in Q4 2025; LX9851 IND-enabling studies completed and licensed to Novo Nordisk (upfront $45M; up to $1B total; potential near-term $30M milestone); SONATA-HCM Phase 3 site initiation complete with 130 sites and enrollment target 500; Zynquista resubmission data submitted to FDA.

Lexicon Pharmaceuticals (Nasdaq: LXRX) announced that data from three sotagliflozin studies will be presented at the Hypertrophic Cardiomyopathy Society sessions and the American Heart Association Scientific Sessions 2025 in New Orleans on November 7–10, 2025.

Presentations include an oral talk on sotagliflozin reversing adverse cardiac remodeling in HCM mice (Nov 7, 3:00–3:10 PM CT), a Late‑breaking oral trial in HFpEF patients without diabetes (Nov 8, 2:20–2:28 PM CT), and a poster of prespecified pooled analyses from the Phase 3 T2D program (Nov 8, 2:30–3:30 PM CT).

The company said these data differentiate sotagliflozin from other SGLT inhibitors and myosin inhibitors and will be followed by additional presentations at CVCT 2025 in December.

Lexicon Pharmaceuticals (Nasdaq: LXRX) will report third quarter 2025 financial results on Thursday, November 6, 2025, before market open. Management will host a conference call and live webcast on that day at 8:30 a.m. ET (7:30 a.m. CT) to discuss results and provide a business update.

Investors can access the live webcast via the company Events page at https://investors.lexpharma.com/. Participants who wish to ask questions must register to receive dial-in numbers and a unique PIN. An archived webcast will be posted on the Lexicon website after the call.

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.