Clinical Data on Effect of Sotagliflozin on Adipose Distribution in Non-Diabetic Patients will be Presented at the 2025 Cardio Vascular Clinical Trialists Forum

Rhea-AI Summary

Lexicon Pharmaceuticals (Nasdaq: LXRX) will present clinical data on sotagliflozin's effect on adipose tissue distribution in non-diabetic patients with HFpEF at CVCT 2025.

The data derive from SOTA-P-CARDIA, a prospective, randomized, double-blind, placebo-controlled trial conducted by Mount Sinai Medical Center. The presentation is scheduled for Monday, December 8, 2025 at 10:30 a.m. ET and will be delivered by Juan Jose Badimon, Ph.D., at the 22nd Global Cardio Vascular Clinical Trialists Forum (December 8-10, 2025) at the Mayflower Hotel, Washington, D.C.

Lexicon highlighted this dataset alongside recent cardiac remodeling and MACE data as additional evidence of sotagliflozin's differentiated effects versus SGLT2 inhibitors.

Key Figures

Q3 2025 revenue $14.2M Total revenue in Q3 2025 10-Q filing

Q3 2025 net loss $12.8M Net loss in Q3 2025 10-Q filing

Cash & investments $145.0M Balance as of Sept 30, 2025 per 10-Q

Novo Nordisk upfront $45.0M Upfront payment under Novo Nordisk license

ATM program size $75,000,000 At-the-market common stock program detailed in 424B5

Long-term debt $56.5M Oxford term loans carrying value as of Sept 30, 2025

Shares outstanding 363,398,860 Common shares outstanding as of Nov 5, 2025

CVCT 2025 dates Dec 8–10, 2025 Conference window for HFpEF adipose data presentation

Market Reality Check

$1.42 Last Close

Volume Volume 1,284,283 is at 0.62x the 20-day average, indicating subdued pre-news activity. low

Technical Shares at $1.42 were trading above the 200-day MA of $0.96 ahead of this clinical update.

Peers on Argus

Peers showed mixed moves (e.g., AURA +3.03%, FULC -0.84%, SLDB +10.13%), with no momentum scanner signal, suggesting this HFpEF data is more stock-specific than sector-driven.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Nov 25	Investor conferences	Neutral	-0.7%	Participation in two December healthcare investor conferences announced.
Nov 11	Investor conference	Neutral	+9.9%	Jefferies London healthcare conference fireside chat participation disclosed.
Nov 06	Earnings and R&D	Positive	+3.6%	Q3 2025 financials and multiple pipeline milestones, including Novo Nordisk deal.
Nov 04	Clinical data previews	Positive	-2.2%	Upcoming sotagliflozin data presentations at HCMS and AHA detailed.
Oct 30	Earnings date notice	Neutral	+0.8%	Announcement of Q3 2025 earnings release date and conference call.

Pattern Detected

Recent news has produced modest, mixed reactions, while earlier clinical-trial-tagged events saw much larger moves, indicating that trial data can be a key volatility driver.

Recent Company History

Over the last few months, Lexicon has alternated between corporate updates and data-driven catalysts. Q3 2025 results on Nov 06 highlighted stronger revenues and pipeline progress and were followed by modest gains. Multiple conference participation announcements on Nov 11 and Nov 25 brought mixed price responses. A prior sotagliflozin data preview on Nov 04 saw a small decline. Against this backdrop, the new HFpEF adipose distribution data at CVCT 2025 extends the ongoing narrative around sotagliflozin’s differentiated profile.

Market Pulse Summary

This announcement highlights new clinical data on sotagliflozin’s effect on adipose distribution in non-diabetic HFpEF patients from the SOTA-P-CARDIA randomized, double-blind, placebo-controlled study. It builds on prior remodeling and MACE findings presented at other meetings in 2025, broadening the mechanistic picture around sotagliflozin. Investors may watch for the full CVCT 2025 presentation on Dec 8–10, including detailed efficacy and safety metrics and how these data might intersect with Lexicon’s broader cardiovascular strategy.

Key Terms

hfpEF medical

"patients with HFpEF and was conducted by Mount Sinai Medical Center"

Heart failure with preserved ejection fraction (HFpEF) is a type of heart failure where the heart pumps out a normal percentage of blood but has trouble relaxing and filling, so overall blood flow to the body is reduced. For investors, HFpEF matters because it represents a large, growing patient population with substantial hospital costs and unmet treatment needs, making it a focus for drug development, clinical trials, and medical device opportunities.

double-blind medical

"a prospective, randomized, double-blind, placebo-controlled trial"

A double-blind process means that neither the people conducting an activity nor the people involved know certain key details, such as who is receiving a treatment or a placebo. This approach helps prevent bias from influencing the results, making the outcome more trustworthy. For investors, it ensures that decisions or judgments are based on unbiased information rather than preconceived opinions or expectations.

placebo-controlled medical

"randomized, double-blind, placebo-controlled trial that exclusively enrolled"

"Placebo-controlled" describes a testing method where one group receives the actual treatment or intervention, while another group receives a harmless, inactive version called a placebo. This approach helps determine whether the real treatment has genuine effects beyond psychological expectations. For investors, understanding this ensures confidence that reported benefits are real and not influenced by bias or false perceptions.

randomized medical

"SOTA-P-CARDIA, a prospective, randomized, double-blind, placebo-controlled trial"

Randomized means participants or units in a study are assigned to different groups by chance rather than by choice, like flipping a coin to decide who gets a new treatment and who gets a comparison. For investors, randomized designs matter because they reduce bias and make results more trustworthy, so outcomes from randomized studies carry more weight when assessing regulatory approval, commercial prospects, and the risk that trial results will change a company’s valuation.

AI-generated analysis. Not financial advice.

THE WOODLANDS, Texas, Dec. 05, 2025 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) announced clinical data on adipose tissue distribution in non-diabetic patients treated with sotagliflozin will be presented at the 22^nd Global Cardio Vascular Clinical Trialists Forum (CVCT 2025). The conference is being held December 8-10, 2025, at the Mayflower Hotel in Washington, D.C.

This data is from SOTA-P-CARDIA, a prospective, randomized, double-blind, placebo-controlled trial that exclusively enrolled patients with heart failure with preserved ejection fraction (HFpEF) and was conducted by Mount Sinai Medical Center in New York City. 

“This data, in addition to data recently presented at HCMS and AHA on sotagliflozin’s impact on cardiac remodeling and effects on MACE, provide additional evidence of sotagliflozin’s differentiated benefits compared to SGLT2 inhibitors,” said Craig Granowitz, M.D., Ph.D., Lexicon’s senior vice president and chief medical officer. 

Presentation details:

• “Effect of sotagliflozin on adipose distribution in non-diabetic patients with HFpEF” - Monday, December 8th, 10:30 a.m. ET, presented by Juan Jose Badimon, Ph.D., Professor of Medicine and Director of the Atherothrombosis Research Unit at the Cardiovascular Institute, The Mount Sinai School of Medicine, New York, NY. 
  
  

About Sotagliflozin 
Discovered using Lexicon’s unique approach to gene science, sotagliflozin is an oral inhibitor of two proteins responsible for glucose regulation known as sodium-glucose cotransporter types 2 and 1 (SGLT2 and SGLT1). SGLT2 is responsible for glucose and sodium reabsorption by the kidney and SGLT1 is responsible for glucose and sodium absorption in the gastrointestinal tract. Sotagliflozin has been studied in multiple patient populations encompassing heart failure, diabetes, and chronic kidney disease in clinical studies involving approximately 20,000 patients. Sotagliflozin is also currently under investigation for another cardiac condition, hypertrophic cardiomyopathy (HCM). 

About Lexicon Pharmaceuticals    
Lexicon is a biopharmaceutical company with a mission of pioneering medicines that transform patients’ lives. Through the Genome5000™ program, Lexicon’s unique genomics target discovery platform, Lexicon scientists studied the role and function of nearly 5,000 genes and identified more than 100 protein targets with significant therapeutic potential in a range of diseases. Through the precise targeting of these proteins, Lexicon is pioneering the discovery and development of innovative medicines to treat disease safely and effectively. Lexicon has a pipeline of promising drug candidates in discovery and clinical and preclinical development in neuropathic pain, hypertrophic cardiomyopathy (HCM), metabolism and other indications. For additional information, please visit www.lexpharma.com.

Safe Harbor Statement    
This press release contains “forward-looking statements,” including statements relating to Lexicon’s financial position and long-term outlook on its business, including the commercialization of its approved products and the clinical development of, regulatory filings for, and potential therapeutic and commercial potential of sotagliflozin and its other drug candidates. In addition, this press release also contains forward looking statements relating to Lexicon’s growth and future operating results, discovery, development and commercialization of products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. All forward-looking statements are based on management’s current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including Lexicon’s ability to meet its capital requirements, successfully commercialize its approved products, successfully conduct preclinical and clinical development and obtain necessary regulatory approvals of its other drug candidates on its anticipated timelines, achieve its operational objectives, obtain patent protection for its discoveries and establish strategic alliances, as well as additional factors relating to manufacturing, intellectual property rights, and the therapeutic or commercial value of its approved products and other drug candidates. Any of these risks, uncertainties and other factors may cause Lexicon’s actual results to be materially different from any future results expressed or implied by such forward-looking statements. Information identifying such important factors is contained under “Risk Factors” in Lexicon’s annual report on Form 10-K for the year ended December 31, 2024, as filed with the Securities and Exchange Commission. Lexicon undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.    

For Investor and Media Inquiries:  
Lisa DeFrancesco    
Lexicon Pharmaceuticals, Inc.   
lexinvest@lexpharma.com  

FAQ

When and where will Lexicon (LXRX) present sotagliflozin adipose distribution data at CVCT 2025?

Presentation is Monday, December 8, 2025 at 10:30 a.m. ET at CVCT 2025, Mayflower Hotel, Washington, D.C.

What study provided the sotagliflozin adipose distribution data being shown by Lexicon (LXRX)?

The data come from SOTA-P-CARDIA, a prospective, randomized, double-blind, placebo-controlled trial.

Which patient population was enrolled in SOTA-P-CARDIA for the LXRX sotagliflozin presentation?

SOTA-P-CARDIA exclusively enrolled non-diabetic patients with heart failure with preserved ejection fraction (HFpEF).

Who will present the sotagliflozin adipose distribution findings for Lexicon (LXRX) at CVCT 2025?

The presenter is Juan Jose Badimon, Ph.D., Professor of Medicine and Director of the Atherothrombosis Research Unit, Mount Sinai.

How did Lexicon (LXRX) position the new sotagliflozin adipose data relative to prior presentations?

Lexicon said the adipose data, together with recent HCMS and AHA cardiac remodeling and MACE data, provide additional evidence of sotagliflozin's differentiated benefits versus SGLT2 inhibitors.