Lexicon to Present Data on Effect of Kidney Function on the Long-term Efficacy and Safety of Sotagliflozin in Patients with Type 1 Diabetes at 19th International Conference on Advanced Technologies & Treatments for Diabetes

Rhea-AI Summary

Lexicon (NASDAQ: LXRX) will present post hoc clinical data on sotagliflozin at ATTD on March 12, 2026, assessing kidney function's effect on one-year efficacy and safety in type 1 diabetes.

Using pooled 52-week placebo-controlled trials, sotagliflozin (200 mg, 400 mg) improved HbA1c, body weight, systolic blood pressure and reduced total insulin use and clinically important hypoglycemia in patients with normal and mildly reduced kidney function; effects were less pronounced in CKD Class 3A. Lexicon plans an NDA resubmission for ZYNQUISTA (sotagliflozin) in 2026.

Positive

• Improved HbA1c, body weight and systolic blood pressure after 52 weeks in CKD Class 1 and 2
• Reduced total insulin use after 52 weeks versus placebo in patients with normal and mildly reduced kidney function
• Reduced events of blood glucose ≤55 mg/dL (clinically important hypoglycemia) regardless of kidney function
• Company remains on track to resubmit the NDA for ZYNQUISTA in 2026

Negative

• Efficacy effects were not as pronounced in patients with CKD Class 3A (eGFR 45 to <60)
• Findings derive from a post hoc analysis, which limits the strength of causal conclusions

News Market Reaction – LXRX

+3.61%

1 alert

+3.61% News Effect

On the day this news was published, LXRX gained 3.61%, reflecting a moderate positive market reaction.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Trial duration: 52-week Sotagliflozin dose: 200 mg Sotagliflozin dose: 400 mg +5 more

8 metrics

Trial duration 52-week Placebo-controlled sotagliflozin trials in type 1 diabetes

Sotagliflozin dose 200 mg Dose used in pooled 52-week trials with insulin

Sotagliflozin dose 400 mg Higher dose used in pooled 52-week trials with insulin

eGFR CKD Class 3A 45 to <60 mL/min/1.73m2 Lowest kidney function subgroup analyzed

eGFR CKD Class 2 60 to <90 mL/min/1.73m2 Mildly reduced kidney function subgroup

eGFR CKD Class 1 ≥90 mL/min/1.73m2 Normal kidney function subgroup

Hypoglycemia threshold ≤55 mg/dL (3 mmol/L) Blood glucose cutoff for hypoglycemia events

ATTD dates March 11–14, 2026 19th ATTD conference in Barcelona where data are presented

Market Reality Check

Price: $1.72 Vol: Volume 3,519,367 vs 20-da...

normal vol

$1.72 Last Close

Volume Volume 3,519,367 vs 20-day average 2,576,324 (relative volume 1.37) normal

Technical Price 1.66 is trading above 200-day MA at 1.22

Peers on Argus

Momentum scanner flagged only SLDB moving, down 1.34% with no news, while LXRX w...

1 Down

Momentum scanner flagged only SLDB moving, down 1.34% with no news, while LXRX was down 1.19%. Limited peer activity suggests the move was more stock-specific than sector-driven.

Historical Context

5 past events · Latest: Mar 05 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Mar 05	Q4/FY25 earnings	Positive	+0.6%	Reported FY2025 revenue growth, narrowed net loss, and key pipeline milestones.
Mar 03	Investor conferences	Neutral	+1.2%	Participation in three March investor events including a Leerink fireside chat.
Feb 26	Earnings date set	Neutral	+0.0%	Announced timing of Q4 2025 results release and related conference call.
Feb 06	Offering closed	Negative	-2.4%	Closed public offering and concurrent private placement raising about $94.6M.
Jan 30	Offering priced	Negative	-19.4%	Priced public offering and private placement for roughly $94.6M in gross proceeds.

Pattern Detected

Recent capital raises with offerings in late January and early February saw negative reactions, while earnings and corporate updates around early March had modestly positive or flat price responses.

Recent Company History

Over the last few months, Lexicon balanced financing and pipeline progress. Two late-January and early-February offerings tied to roughly $94.6M in capital resulted in negative price reactions. Subsequent updates, including the March 5, 2026 Q4/FY2025 results and March conference participation announcements, saw small positive or flat moves. Today’s post hoc sotagliflozin data presentation fits into an ongoing effort to support a planned 2026 NDA resubmission in type 1 diabetes.

Market Pulse Summary

This announcement highlights post hoc analyses indicating sotagliflozin improved HbA1c, weight, bloo...

Analysis

This announcement highlights post hoc analyses indicating sotagliflozin improved HbA1c, weight, blood pressure and hypoglycemia measures over 52 weeks, particularly in patients with CKD Classes 1 and 2, without a kidney-function–linked rise in diabetic ketoacidosis. It also reiterates plans to resubmit the ZYNQUISTA NDA for type 1 diabetes in 2026, supported by the STENO1 study. Investors may track additional quantitative data from ATTD, STENO1 readouts, and any subsequent FDA interactions tied to this resubmission plan.

Key Terms

sotagliflozin, sglt1, sglt2, hbA1c, +4 more

8 terms

sotagliflozin medical

"sotagliflozin, a dual SGLT1 and SGLT2 inhibitor, improved glycemic control"

Sotagliflozin is a medicine that blocks two proteins involved in how the body handles sugar: one that helps absorb sugar from food and one that helps the kidneys hold onto sugar. By reducing blood sugar and affecting fluid balance, it can help treat diabetes and certain heart conditions. Investors watch it because success or failure in clinical trials and approvals can meaningfully affect a drugmaker’s revenue potential and regulatory risk.

sglt1 medical

"sotagliflozin, a dual SGLT1 and SGLT2 inhibitor, improved glycemic control"

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.

sglt2 medical

"sotagliflozin, a dual SGLT1 and SGLT2 inhibitor, improved glycemic control"

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.

hbA1c medical

"efficacy (as measured by HbA1c, body weight and systolic blood pressure)"

A1c (HbA1c) is a blood test that measures how much sugar has stuck to red blood cells over the past two to three months, giving a single number that reflects average blood glucose control—think of it as a running average score for blood sugar. Investors watch A1c because it’s a common clinical measure used to judge whether diabetes drugs, devices or care programs work, influence regulatory approvals, treatment guidelines and market demand.

systolic blood pressure medical

"measured by HbA1c, body weight and systolic blood pressure) and safety"

Systolic blood pressure is the top number in a blood pressure reading, measuring the pressure in your arteries when your heart beats and pumps blood. It indicates how forcefully the heart pushes blood through the body. For investors, it can symbolize the maximum stress or intensity in a system, helping to assess overall health risks or stability.

diabetic ketoacidosis medical

"safety (as measured by hypoglycemia and diabetic ketoacidosis) of 200 mg"

Diabetic ketoacidosis is a serious, sudden complication of uncontrolled diabetes where the body, unable to use sugar for energy, breaks down fat and produces acidic chemicals called ketones, causing very high blood sugar, dehydration and a dangerous change in blood chemistry. It matters to investors because DKA drives hospital admissions, affects demand for diabetes medicines, devices and emergency care, and can influence clinical trial results, regulatory decisions and a company’s costs or liability exposure — like a sudden engine failure forcing expensive repairs.

estimated glomerular filtration rates (eGFR) medical

"subgrouped by estimated glomerular filtration rates (eGFR, a measure of kidney function)"

Estimated glomerular filtration rate (eGFR) is a calculated measure of how well the kidneys are filtering blood, expressed as the volume of fluid cleaned per minute. Think of it as the speedometer for the body's waste filter: lower numbers mean weaker filtering. Investors watch eGFR because it affects drug dosing, safety profiles, clinical trial outcomes and market size for kidney-related treatments, influencing regulatory decisions and commercial prospects.

new drug application (nda) regulatory

"remains on track to resubmit the New Drug Application (NDA) for ZYNQUISTA"

A new drug application (NDA) is a formal request submitted to regulatory authorities to gain approval for a new medication to be sold and used by the public. It is a comprehensive review process that examines the drug’s safety, effectiveness, and manufacturing quality. For investors, an NDA approval can signal a potential breakthrough product and influence a company's stock value.

AI-generated analysis. Not financial advice.

Post hoc data analysis concluded that sotagliflozin, a dual SGLT1 and SGLT2 inhibitor, improved glycemic control after one year in patients with normal and mildly reduced kidney function

THE WOODLANDS, Texas, March 11, 2026 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that results of a post hoc analysis of clinical data evaluating the impact of kidney function on the long-term efficacy and safety of sotagliflozin on people with type 1 diabetes will be delivered as a short oral presentation tomorrow, March 12, during the 19th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD). The congress is being held March 11-14, 2026, in Barcelona, Spain.

“Recognizing that a patient’s kidney function can impact the efficacy of SGLT inhibitors, we conducted this post hoc analysis of clinical data from two identically-designed trials in patients with type 1 diabetes and were encouraged to find that treatment with sotagliflozin resulted in improvements in multiple efficacy measures after one year in both those with normal kidney function and those with mildly reduced kidney function,” said Craig Granowitz, M.D., Ph.D., Lexicon’s senior vice president and chief medical officer. “Not only was sotagliflozin shown to improve cardiometabolic parameters in this patient population, but it also reduced clinically important hypoglycemia events, which are a leading cause of acute mortality and morbidity and can be life-threatening.”

Using pooled data from two 52-week, placebo-controlled trials of 200 mg or 400 mg doses of sotagliflozin added to optimized insulin, investigators compared the efficacy (as measured by HbA1c, body weight and systolic blood pressure) and safety (as measured by hypoglycemia and diabetic ketoacidosis) of 200 mg or 400 mg doses of sotagliflozin as compared to the placebo treatment arms in such studies, subgrouped by estimated glomerular filtration rates (eGFR, a measure of kidney function) of 45 to <60 (chronic kidney disease [CKD] Class 3A), 60 to <90 (CKD Class 2), and ≥90 mL/min/1.73m² (CKD Class 1).

Results showed that both doses of sotagliflozin significantly decreased HbA1c, body weight, systolic blood pressure and total insulin use compared to placebo after 52 weeks in patients with CKD Class 1 and 2. These positive effects with sotagliflozin were not as pronounced in patients with CKD Class 3A. Additionally, sotagliflozin reduced events of blood glucose ≤55 mg/dL (3 mmol/L) regardless of patients’ kidney function. Results did not show a trend toward increased incidence of diabetic ketoacidosis based on patients’ kidney function.

Lexicon remains on track to resubmit the New Drug Application (NDA) for ZYNQUISTA^® (sotagliflozin) glycemic control in patients with type 1 diabetes in 2026 based upon U.S. Food and Drug Administration (FDA) feedback and additional clinical data received to date from the STENO1 study (Clinicaltrials.gov: NCT06082063). STENO1 is a third-party funded, investigator-initiated study of sotagliflozin and other agents being conducted by the Steno Diabetes Center in Denmark.

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” within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934, as amended. All forward-looking statements, including, without limitation, statements about the completion and timing of the offering, the use of proceeds from the offering and the grant of the option to the underwriters and the private placement purchaser to purchase additional shares, 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, 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 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 and other subsequent disclosure documents filed with the SEC. 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

What did Lexicon (LXRX) present about sotagliflozin and kidney function on March 12, 2026?

They reported a post hoc analysis showing one-year improvements in glycemic and cardiometabolic measures in patients with normal and mildly reduced kidney function. According to the company, pooled 52-week trial data showed benefits on HbA1c, weight, systolic blood pressure and insulin use.

How did sotagliflozin perform in patients with CKD Class 3A in the LXRX analysis?

The analysis found that benefits were less pronounced in CKD Class 3A (eGFR 45 to <60). According to the company, efficacy on HbA1c, weight and blood pressure was smaller compared with CKD Class 1 and 2 patients.

Did the LXRX data show any change in diabetic ketoacidosis risk by kidney function?

Results did not show a trend toward increased diabetic ketoacidosis incidence based on kidney function. According to the company, subgroup analysis by eGFR did not reveal higher DKA rates across kidney-function groups.

Does the LXRX announcement affect the regulatory timeline for ZYNQUISTA (sotagliflozin)?

Lexicon said it remains on track to resubmit the NDA for ZYNQUISTA in 2026. According to the company, FDA feedback plus additional STENO1 study data support the planned 2026 resubmission.

How did sotagliflozin affect hypoglycemia events across kidney-function subgroups in the LXRX analysis?

Sotagliflozin reduced events of blood glucose ≤55 mg/dL regardless of kidney function. According to the company, reductions in clinically important hypoglycemia were observed across CKD Class 1, 2 and 3A subgroups.