Lexicon Announces New Post Hoc SOLOIST-WHF Analysis Demonstrating Consistent Sotagliflozin Results Across Baseline Blood Pressure Levels in Patients with Recent Worsening Heart Failure

Rhea-AI Summary

Lexicon (Nasdaq: LXRX) reported a new post hoc analysis from the Phase 3 SOLOIST‑WHF trial, presented at ESC Congress 2026 and published in JACC: Heart Failure, evaluating sotagliflozin across baseline systolic blood pressure (SBP) in 1,222 patients with type 2 diabetes recently hospitalized for worsening heart failure.

According to Lexicon, sotagliflozin’s treatment effect on total cardiovascular deaths and heart failure-related events was consistent across SBP ranges, including patients with SBP as low as 100 mmHg, without increased hypotension or acute kidney injury. In SBP <110 mmHg (n=201), the hazard ratio was 0.56 (95% CI 0.33–0.95; p=0.03); in SBP ≥110 mmHg (n=1175), the hazard ratio was 0.69 (95% CI 0.53–0.91; p=0.01).

Positive

• SOLOIST‑WHF post hoc: consistent sotagliflozin effect on CV death/HF events across baseline SBP, including patients with SBP as low as 100 mmHg
• Low SBP subgroup <110 mmHg (n=201): sotagliflozin HR 0.56 (95% CI 0.33–0.95), p=0.03, for total cardiovascular deaths and HF-related events
• Higher SBP subgroup ≥110 mmHg (n=1175): sotagliflozin HR 0.69 (95% CI 0.53–0.91), p=0.01, for total cardiovascular deaths and HF-related events
• No significant difference in adverse events of hypotension (p=0.34) or acute kidney injury (p=0.69) between sotagliflozin and placebo

Negative

• None.

Market Context

Recent clinical updates included a -2.62% move after SONATA-HCM enrollment completion, showing that ...

Analysis

Recent clinical updates included a -2.62% move after SONATA-HCM enrollment completion, showing that development progress had not always aligned with the stock’s recorded response. This analysis strengthened the evidence base, while the active S-3 resale registration remained a structural consideration.

Key Figures

Trial phase: Phase 3 Randomized patients: 1,222 patients Lowest baseline SBP: 100 mmHg +4 more

7 metrics

Trial phase Phase 3 SOLOIST-WHF trial

Randomized patients 1,222 patients Patients with type 2 diabetes and worsening heart failure

Lowest baseline SBP 100 mmHg Patients with recent worsening heart failure

Low-SBP cardiovascular outcome HR 0.56; 95% CI 0.33-0.95; p=0.03 Baseline SBP <110 mmHg; n=201

Hypotension adverse events p=0.34 No difference between treatment groups

Acute kidney injury p=0.69 No difference between treatment groups

Higher-SBP cardiovascular outcome HR 0.69; 95% CI 0.53-0.91; p=0.01 Baseline SBP ≥110 mmHg; n=1175

Historical Context

5 past events · Latest: Aug 24 (Positive)

Pattern 5 events

Date	Event	Sentiment	24h Move	Catalyst
Aug 24	Milestone payment	Positive	+0.9%	Novo Nordisk triggered a third $10 million milestone payment for LX9851 development.
Aug 06	Quarterly earnings	Negative	-3.7%	Quarterly revenue declined and the company reported a $31.8 million net loss.
Jul 30	Earnings scheduling	Neutral	+0.9%	Lexicon scheduled its second-quarter 2026 results and investor conference call.
Jul 27	Trial enrollment	Positive	-2.6%	Lexicon completed randomization in the pivotal Phase 3 SONATA-HCM study.
Jun 03	Clinical presentation	Positive	-2.1%	Lexicon announced new clinical data presentations at the ADA 2026 Scientific Sessions.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

LXRX aligned with its recent negative earnings reaction but diverged from positive clinical and development updates on multiple occasions.

Key Terms

post hoc analysis, hypotension, acute kidney injury, SGLT2, +1 more

5 terms

post hoc analysis technical

"results from a post hoc analysis of the Phase 3 SOLOIST-WHF trial"

Post hoc analysis is an exploratory look at data carried out after a study or trial is finished to search for patterns or effects that were not specified beforehand. Because it’s done after seeing the results, findings can arise by chance and are less reliable than preplanned tests; investors should treat post hoc claims as hypothesis-generating signals that may need confirmatory studies or regulatory review before they meaningfully affect a company’s value.

hypotension medical

"without an increase in hypotension or acute kidney injury (AKI)"

Hypotension is abnormally low blood pressure that reduces the flow of blood and oxygen to the body’s organs, which can cause dizziness, fainting, fatigue or in severe cases organ damage. For investors, it matters because drugs, devices or procedures that cause or treat hypotension can change clinical trial outcomes, safety labels, prescribing use and healthcare costs—similar to a drop in water pressure that can disrupt an entire building’s plumbing.

acute kidney injury medical

"without an increase in hypotension or acute kidney injury (AKI)"

A sudden decline in how well the kidneys remove waste and balance fluids, often developing over hours or days; think of it like an engine that abruptly loses power and can’t filter efficiently. It matters to investors because it can drive higher medical costs, alter clinical trial results, trigger regulatory scrutiny, lead to drug label changes or recalls, and affect revenue and liability for healthcare and life sciences companies.

SGLT2 medical

"known as sodium-glucose cotransporter types 2 and 1 (SGLT2 and SGLT1)"

SGLT2 is a protein in the kidneys that acts like a tiny reabsorption gate, returning glucose from urine back into the bloodstream; drugs called SGLT2 inhibitors block this gate to help lower blood sugar. Investors care because therapies aimed at SGLT2 have broad market potential beyond diabetes—often affecting heart and kidney outcomes—so clinical results, approvals, or safety signals can materially change a drug maker’s revenue and regulatory risk, similar to a new feature that expands or shrinks a product’s customer base.

SGLT1 medical

"known as sodium-glucose cotransporter types 2 and 1 (SGLT2 and SGLT1)"

SGLT1 is a protein in the body’s lining of the gut and some kidney cells that acts like a doorway, moving sugar from the digestive tract into cells. It matters to investors because drugs that block or modify this doorway can change how the body handles blood sugar, appetite and fluid balance, so successes or setbacks in SGLT1-targeted therapies can affect drug sales, trial outcomes, regulatory risk and long-term company value.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Findings presented at ESC Congress 2026 and simultaneously published in JACC: Heart Failure

THE WOODLANDS, Texas, Aug. 31, 2026 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced results from a post hoc analysis of the Phase 3 SOLOIST-WHF trial evaluating the efficacy and safety of sotagliflozin across the spectrum of baseline systolic blood pressure in patients recently hospitalized for worsening heart failure.

The data, which were presented yesterday at ESC Congress 2026 in Munich, Germany and simultaneously published in JACC: Heart Failure¹, demonstrated that the results of sotagliflozin treatment were maintained regardless of baseline systolic blood pressure. Among patients with baseline systolic blood pressure as low as 100 mmHg, treatment with sotagliflozin was associated with a reduction in cardiovascular death and heart failure-related events, without an increase in hypotension or acute kidney injury (AKI). 

“Patients hospitalized for recent worsening heart failure and lower systolic blood pressure are often considered among the most clinically vulnerable,” said Craig Granowitz, M.D., Ph.D., Lexicon’s senior vice president and chief medical officer. “We were encouraged to see that the results of sotagliflozin treatment remained consistent across the spectrum of baseline blood pressure in SOLOIST-WHF, providing additional insight into the potential utility of sotagliflozin in a particularly high-risk heart failure population.”

The SOLOIST-WHF trial randomized 1,222 patients with type 2 diabetes admitted for worsening heart failure to treatment with the dual SGLT 1 and 2 inhibitor sotagliflozin or placebo. The analysis demonstrated that the effect of sotagliflozin was consistent across the spectrum of baseline systolic blood pressure (SBP), with no evidence that treatment effect varied by baseline blood pressure.

Among patients with a baseline SBP <110 mmHg (n=201), those randomized to sotagliflozin experienced a reduction in total occurrences of cardiovascular deaths and HF-related events (HR 0.56 (95% CI 0.33-0.95), p=0.03). These data suggest efficacy of sotagliflozin in even the lowest SBP stratum. There was no difference in the incidence of adverse events of hypotension between treatment groups (p=0.34) or AKI (p=0.69). Additionally, patients with a baseline SBP ≥ 110 mmHg (n=1175) also experienced a reduction in total occurrences of cardiovascular deaths and HF-related events (HR 0.69 (95%CI 0.53-0.91), p=0.01).

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. Lexicon has a pipeline of drug candidates in discovery, preclinical, and clinical development in neuropathic pain, hypertrophic cardiomyopathy (HCM), obesity and metabolic disorders, and other cardiometabolic indications. For additional information, please visit www.lexpharma.com.   

Safe Harbor Statement
This press release contains “forward-looking statements,” including statements relating to the research, development and therapeutic and commercial potential of sotagliflozin. In addition, this press release may also contain forward-looking 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 its other drug candidates. 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, 2025, 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 Media Inquiries: 
Dave Belian 
Lexicon Pharmaceuticals, Inc. 
lexinvest@lexpharma.com 
  
For Investor Inquiries: 
Lisa DeFrancesco 
Lexicon Pharmaceuticals, Inc. 
lexinvest@lexpharma.com 

¹ Zitelny E, et al. Benefit of Sotagliflozin Across the Full Range of Baseline Blood Pressure in the SOLOIST-WHF Trial. JACC: Heart Failure. Published online August 2026. DOI: 10.1016/j.jchf.2026.103368.

FAQ

What did Lexicon (LXRX) announce about sotagliflozin at ESC Congress 2026?

Lexicon announced a post hoc SOLOIST‑WHF analysis showing sotagliflozin’s treatment effect was consistent across baseline systolic blood pressure levels. According to Lexicon, this included patients recently hospitalized for worsening heart failure with type 2 diabetes, and results were simultaneously published in JACC: Heart Failure in August 2026.

How did sotagliflozin perform in SOLOIST‑WHF patients with low baseline blood pressure?

In patients with baseline systolic blood pressure below 110 mmHg, sotagliflozin was associated with fewer cardiovascular deaths and heart failure-related events. According to Lexicon, this subgroup (n=201) showed a hazard ratio of 0.56 (95% CI 0.33–0.95; p=0.03), suggesting benefit even at lower blood pressure levels.

Were hypotension or acute kidney injury increased with sotagliflozin in SOLOIST‑WHF?

According to Lexicon, sotagliflozin did not increase adverse events of hypotension or acute kidney injury compared with placebo. The post hoc analysis reported no difference in hypotension (p=0.34) or acute kidney injury (p=0.69) incidence across treatment groups in the SOLOIST‑WHF population.

What were the overall SOLOIST‑WHF results for sotagliflozin across blood pressure ranges?

Sotagliflozin’s effect on total cardiovascular deaths and heart failure-related events was consistent across systolic blood pressure ranges. According to Lexicon, hazard ratios were 0.56 for SBP <110 mmHg and 0.69 for SBP ≥110 mmHg, both with statistically significant p-values in this post hoc analysis.

How many patients were included in the SOLOIST‑WHF trial of sotagliflozin reported by Lexicon (LXRX)?

According to Lexicon, the Phase 3 SOLOIST‑WHF trial randomized 1,222 patients with type 2 diabetes admitted for worsening heart failure. These patients received either sotagliflozin, a dual SGLT1 and SGLT2 inhibitor, or placebo, enabling assessment of efficacy and safety across different baseline systolic blood pressure strata.

What is sotagliflozin and in which conditions is Lexicon studying it?

Sotagliflozin is an oral dual SGLT2 and SGLT1 inhibitor that targets glucose and sodium handling in kidney and gut. According to Lexicon, it has been studied in heart failure, diabetes and chronic kidney disease in about 20,000 patients, and is under investigation for hypertrophic cardiomyopathy.

What other therapeutic areas are in Lexicon’s (LXRX) development pipeline beyond sotagliflozin?

Lexicon reports a pipeline spanning neuropathic pain, hypertrophic cardiomyopathy, obesity, metabolic disorders and other cardiometabolic indications. According to Lexicon, these programs include drug candidates across discovery, preclinical and clinical stages, aligning with its mission to develop medicines that transform patients’ lives.