Preklinické studie ukázaly, že sotagliflozin zlepšil strukturu a funkci srdce u myší s hypertrofickou kardiomyopatií a snížil aktivaci krevních destiček i tvorbu trombů.
-- Preclinical study demonstrates positive effects of sotagliflozin on cardiac function and structure in hypertrophic cardiomyopathy --
-- Second preclinical study shows inhibitory effects of sotagliflozin on platelet activity and thrombus formation --
-- Findings underscore differentiated biology associated with dual SGLT1 and SGLT 2 inhibition --
THE WOODLANDS, Texas, Oct. 21, 2026 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), a leading cardiometabolic biopharmaceutical company, today highlighted findings from two newly reported preclinical studies that provide additional insight into the biological effects of sotagliflozin, Lexicon's first-in-class dual SGLT1 and SGLT2 inhibitor. The investigator-initiated studies, funded by Lexicon and conducted by independent academic investigators, demonstrated favorable effects of sotagliflozin on key pathways involved in hypertrophic cardiomyopathy (HCM) and thrombotic cardiovascular events.
The first study, published in the Journal of Molecular and Cellular Cardiology Plus1, found that sotagliflozin improved cardiac structure and function in a mouse model of hypertrophic cardiomyopathy, while reducing oxidative stress and upregulating mitochondrial gene sets associated with energy production in myocardial tissues. Investigators reported that sotagliflozin normalized measures of diastolic function, reversed progression of cardiac hypertrophy and reduced cardiac fibrosis, findings that support further evaluation of its potential in HCM.
The second study, published in the Journal of Clinical Investigation2, demonstrated that sotagliflozin, but not the selective SGLT2 inhibitor empagliflozin, reduced platelet activation and thrombus formation in ex vivo human blood and animal models, including an SGLT1 gene murine knockout model, without adversely affecting normal hemostasis. These findings provide additional insight into the differentiated biology of dual SGLT1 and SGLT2 inhibition and may provide support for previously observed reductions in myocardial infarction and stroke risk associated with sotagliflozin in heart failure and Type 2 diabetes clinical studies
“These studies add to a growing body of evidence demonstrating the broad biological effects of sotagliflozin across multiple pathways relevant to cardiovascular disease,” said Craig Granowitz, M.D., Ph.D., senior vice president and chief medical officer of Lexicon. “From cardiac remodeling and mitochondrial function to platelet activation and thrombosis, the findings continue to expand our understanding of the differentiated biology associated with dual SGLT1 and SGLT2 inhibition and further support the scientific rationale for evaluating sotagliflozin in areas of significant unmet need, including hypertrophic cardiomyopathy.”
Lexicon is currently evaluating sotagliflozin in the ongoing Phase 3 SONATA-HCM trial in patients with symptomatic obstructive and non-obstructive hypertrophic cardiomyopathy. Topline results are expected in the first quarter of 2027.
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 hypertrophic cardiomyopathy (HCM).
About Lexicon Pharmaceuticals
Lexicon Pharmaceuticals is a biopharmaceutical company pursuing novel medicines for patients with serious cardiometabolic diseases. Building on a proven legacy in genetic target discovery, Lexicon is advancing a clinical pipeline in areas of significant and often underserved need, with programs in hypertrophic cardiomyopathy (HCM), type 1 diabetes (T1D), obesity and other related metabolic conditions. Lexicon is committed to developing differentiated therapies that can be integrated broadly into clinical practice, with the goal of expanding treatment options for patients. Its capabilities extend from early-stage target discovery through clinical development and commercialization, strategically paired with high-impact collaborations to maximize the global reach of its medicines.
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 hypertrophic cardiomyopathy. 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. 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, 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. [email protected]
For Investor Inquiries:
Lisa DeFrancesco
Lexicon Pharmaceuticals, Inc. [email protected]
1 Qin F, et al. Sotagliflozin corrects myocardial phenotype, mitochondrial gene expression and oxidative stress in mice with hypertrophic cardiomyopathy. Journal of Molecular and Cellular Cardiology Plus. 2026;100873. doi:10.1016/j.jmccpl.2026.100873.
2 Stanger L, et al. SGLT1/2 inhibitor sotagliflozin, but not SGLT2-selective inhibitor empagliflozin, attenuates platelet activation and thrombosis. Journal of Clinical Investigation. 2026. In-Press Preview. doi:10.1172/JCI201899.
Společnost Lexicon dokončila nábor do fáze III studie SONATA-HCM se sotagliflozinem u hypertrofické kardiomyopatie. První data očekává v 1. čtvrtletí 2027.
Lexicon Pharmaceuticals NASDAQ: LXRX said it has completed enrollment in its Phase III SONATA-HCM study of sotagliflozin in hypertrophic cardiomyopathy, with topline data expected in the first quarter of 2027.
Speaking at the H.C. Wainwright 28th Annual Global Investment Conference, Chief Executive Officer Dr. Mike Exton said the company is continuing its transition toward a cardiometabolic focus, with sotagliflozin programs in hypertrophic cardiomyopathy, or HCM, and type 1 diabetes among its principal near-term priorities.
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SONATA-HCM Enrollment Exceeds Target Exton said SONATA-HCM was designed to enroll 500 patients across obstructive and non-obstructive forms of HCM, but the trial ultimately “substantially over-enrolled” that target. Enrollment was completed at the end of July, and the 26-week study uses the Kansas City Cardiomyopathy Questionnaire, or KCCQ, as an endpoint.
The company expects to present baseline demographic information from the trial at an HCM-focused medical meeting after the data are cleaned, Exton said.
Lexicon executives emphasized their view that obstructive and non-obstructive HCM represent a continuum rather than wholly separate diseases. Exton said diastolic dysfunction and left ventricular hypertrophy are central features across the condition, while the distinction between obstructive and non-obstructive disease primarily reflects the location of heart-muscle thickening.
Chief Medical Officer Dr. Craig Granowitz said HCM has historically been defined in part by available treatments, including surgery and therapies that reduce cardiac contractility. He said sotagliflozin is intended to act through multiple mechanisms, including SGLT2-related cardiorenal and decongestion effects as well as potential direct effects on myocardial energetics through SGLT1.
According to Granowitz, SONATA-HCM has broad inclusion criteria, including patients with ejection fractions as low as 50%. The study also permits certain patients using cardiac myosin inhibitors, or CMIs, subject to entry criteria. He contrasted that approach with CMI use in patients with more hyperdynamic heart function.
Commercial Planning and HCM Positioning Exton said Lexicon has begun pre-launch planning for a potential HCM commercialization effort. The company promoted Rachel Martens, previously responsible for partnership and strategy activities, to chief commercial officer. Lexicon also hired a head of marketing, a head of access and five medical science liaisons, he said.
The company is conducting market research on the potential positioning of sotagliflozin. Exton said physicians have identified an unmet need in non-obstructive HCM, where he said there are currently no approved treatment options.
He said the company believes sotagliflozin could provide an oral, once-daily treatment option with potential use across both obstructive and non-obstructive disease, depending on study results and regulatory decisions. Exton also cited the drug’s existing heart-failure safety record and said its potential profile could differ from currently approved CMIs, which can require risk-management procedures related to potential reductions in ejection fraction.
Type 1 Diabetes Resubmission Planned In type 1 diabetes, Exton said the third-party STENO1 study has completed the recruitment and drug-exposure requirements Lexicon believes are needed to support a U.S. Food and Drug Administration resubmission for sotagliflozin.
He said STENO1 is an open-label Danish cardiovascular outcomes study and that observed diabetic ketoacidosis, or DKA, rates in the sotagliflozin group have been similar to standard of care and lower than rates observed in Lexicon’s prior inTandem program. The company plans to resubmit its application in the fourth quarter and said a potential FDA decision could occur in 2027.
Partnership and Pipeline Updates Exton also discussed Lexicon’s partnerships with Viatris and Novo Nordisk. Viatris has submitted and received approvals for sotagliflozin in the United Arab Emirates and Bahrain for heart failure, he said, while additional submissions in markets outside the U.S. and European Union are continuing.
For LX9851, Lexicon’s non-incretin obesity mechanism partnered with Novo Nordisk, Exton said Lexicon has received three $10 million milestone payments this year, in addition to $45 million received in the prior year. He said the agreement carries up to $1 billion in potential milestone payments, along with high-single-digit to low-double-digit sales royalties.
Lexicon is also preparing for a potential Phase III program for pilavapadin in diabetic peripheral neuropathic pain and plans to present additional preclinical information later this year regarding AAK1 biology and potential further indications, Exton said.
About Lexicon Pharmaceuticals (NASDAQ:LXRX)Lexicon Pharmaceuticals, Inc is a biopharmaceutical company that discovers and develops medicines for human disease. Founded in 1995 and headquartered in The Woodlands, Texas, the company uses its drug-discovery platform and expertise in biology to identify potential treatments for conditions with significant unmet medical needs.
Lexicon's marketed products include XERMELO (telotristat ethyl), an oral medicine used to treat carcinoid syndrome diarrhea in adults whose symptoms are not adequately controlled by somatostatin analog therapy.
This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected].
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Lexicon oznámil, že sotagliflozin ve studii SOLOIST-WHF přinesl konzistentní výsledky napříč výchozím systolickým tlakem u pacientů s nedávným zhoršením srdečního selhání. I při SBP 100 mmHg snižoval kardiovaskulární úmrtí a události související se srdečním selháním bez nárůstu hypotenzí či AKI.
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. [email protected]
For Investor Inquiries:
Lisa DeFrancesco
Lexicon Pharmaceuticals, Inc. [email protected]
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.
Lexicon Pharmaceuticals obdržela od Novo Nordisk třetí milníkovou platbu ve výši 10 milionů USD v roce 2026 po dosažení klíčového milníku v dávkování pacientů ve fázi 1 vývoje LX9851. Celkem už získala 75 milionů USD z potenciálních 1 miliardy USD.
LX9851 is a first-in-class, oral non-incretin candidate being developed by Novo Nordisk for the treatment of obesity and associated metabolic disorders
Lexicon is eligible to receive up to $1 billion in total upfront and milestone payments from the collaboration, plus royalties on net sales
THE WOODLANDS, Texas, Aug. 24, 2026 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that it has earned a third $10 million milestone payment in 2026 from Novo Nordisk A/S following the achievement of a key patient dosing milestone in the ongoing Phase 1 clinical development program for LX9851, a first-in-class oral small molecule inhibitor of ACSL5 being developed for obesity and associated metabolic disorders.
LX9851 is being advanced by Novo Nordisk under the companies' exclusive worldwide license agreement signed in 2025. Under the terms of the agreement, Novo Nordisk obtained an exclusive, worldwide license to develop, manufacture and commercialize LX9851 in all indications.
With the achievement of this milestone, Lexicon has now earned $75 million of the $1 billion in potential upfront, development, regulatory and commercial milestone payments available under its collaboration with Novo Nordisk. In addition, Lexicon is entitled to receive tiered royalties on future net sales of LX9851.
“This milestone represents another important step forward in the development of LX9851 and further demonstrates the strong execution of our collaboration with Novo Nordisk,” said Mike Exton, CEO and director of Lexicon. “In just over a year, the program has progressed from a licensing agreement to the successful achievement of multiple clinical development milestones. We believe LX9851's novel mechanism and oral profile have the potential to offer an important new approach for people living with obesity and associated metabolic diseases, and we remain excited about the program's continued advancement."
The Phase 1 development program for LX9851 was initiated by Novo Nordisk in March 2026 and is investigating the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple ascending doses of LX9851 compared to placebo in adult subjects who are overweight or obese. The Phase 1 program is expected to be completed in the first quarter of 2027.
About LX9851
LX9851, discovered by Lexicon and in development by Novo Nordisk, is a potent and selective oral small molecule inhibitor of Acyl CoA Synthetase 5 (ACSL5). ACSL5 plays a key role in the metabolic pathway which regulates fat accumulation and energy balance. Preclinical in vivo efficacy data presented at Obesity Week 2024 show that LX9851, when combined with semaglutide, significantly reduced weight, food intake and fat mass compared to semaglutide alone. Separately, LX9851 mitigated weight regain and had positive effects on liver steatosis when introduced after semaglutide discontinuation in the preclinical studies.
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 preclinical and clinical development of LX9851, Lexicon’s financial position and long-term outlook on its business, growth and future operating results, 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, 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 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 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. [email protected]
For Investor Inquiries:
Lisa DeFrancesco
Lexicon Pharmaceuticals, Inc. [email protected]
Lexicon Pharmaceuticals zveřejnila výsledky za 2. čtvrtletí 2026 a na hovoru představila firemní aktualizaci. Společnost zároveň zmínila vývoj programů sotagliflozin, pilavapadin a LX9851.
Lexicon Pharmaceuticals, Inc. (LXRX) Q2 2026 Earnings Call August 6, 2026 8:30 AM EDT
Company Participants
Lisa DeFrancesco - Senior Vice President of Investor Relations & Corporate Communications
Michael Exton - CEO & Director
Craig Granowitz - Senior VP & Chief Medical Officer
Scott Coiante - Senior VP & CFO
Conference Call Participants
Joohwan Kim - Citigroup Inc., Research Division
Brian Balchin - Jefferies LLC, Research Division
Roanna Clarissa Ruiz - Leerink Partners LLC, Research Division
Yasmeen Rahimi - Piper Sandler & Co., Research Division
Presentation
Operator
Welcome to the Lexicon Pharmaceuticals Second Quarter 2026 Financial Results Conference Call. [Operator Instructions] As a reminder, this call is being recorded today, August 6, 2026.
I will now turn the call over to Lisa DeFrancesco, SVP, Investor Relations and Corporate Communications for Lexicon. Please go ahead, Lisa.
Lisa DeFrancesco
Senior Vice President of Investor Relations & Corporate Communications
Thank you, Therese. Good morning, and welcome to our Second Quarter 2026 Earnings Call. Joining me today are Dr. Mike Exton, Lexicon's Chief Executive Officer and Director; Dr. Craig Granowitz, Senior Vice President and Chief Medical Officer; and Scott Coiante, Senior Vice President and Chief Financial Officer.
This morning, Lexicon issued a press release announcing our financial results for the second quarter of 2026, which is available on our website at www.lexpharma.com and through our SEC filings. A webcast of this call, along with the slide presentation is also available on our website.
During this call, we will review the information provided in our release, provide a corporate update and then use the remainder of our time to answer your questions.
Before we begin, let me remind you that we will be making forward-looking statements, including statements relating to the safety, efficacy, clinical development, regulatory status and therapeutic and commercial potential of sotagliflozin, pilavapadin, LX9851 and our other drug programs as well as our business
Lexicon Pharmaceuticals (LXRX - Free Report) came out with a quarterly loss of $0.06 per share in line with the Zacks Consensus Estimate. This compares to earnings of $0.01 per share a year ago. These figures are adjusted for non-recurring items.
A quarter ago, it was expected that this drugmaker would post a loss of $0.04 per share when it actually produced break-even earnings, delivering a surprise of +100%.
Over the last four quarters, the company has surpassed consensus EPS estimates three times.
Lexicon, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $0.69 million for the quarter ended June 2026, missing the Zacks Consensus Estimate by 88.73%. This compares to year-ago revenues of $28.87 million. The company has topped consensus revenue estimates three times over the last four quarters.
The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call.
Lexicon shares have added about 113% since the beginning of the year versus the S&P 500's gain of 12.8%.
What's Next for Lexicon?While Lexicon has outperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock?
There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately.
Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions.
Ahead of this earnings release, the estimate revisions trend for Lexicon was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here.
It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is -$0.06 on $11.16 million in revenues for the coming quarter and -$0.17 on $37.95 million in revenues for the current fiscal year.
Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Biomedical and Genetics is currently in the top 44% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1.
Ovid Therapeutics (OVID - Free Report) , another stock in the same industry, has yet to report results for the quarter ended June 2026.
This company is expected to post quarterly loss of $0.10 per share in its upcoming report, which represents a year-over-year change of -66.7%. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days.
Ovid Therapeutics' revenues are expected to be $0.15 million, down 97.6% from the year-ago quarter.
Společnost Lexicon Pharmaceuticals dokončila nábor do klíčové studie fáze 3 SONATA-HCM se sotagliflozinem u symptomatické hypertrofické kardiomyopatie. Studie překročila cíl 500 pacientů a první výsledky se čekají v 1. čtvrtletí 2027.
Study substantially exceeded enrollment target of 500 patients
Topline results anticipated in Q1 2027
THE WOODLANDS, Texas, July 27, 2026 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that randomization of patients has been completed in the pivotal Phase 3 “SOtaglifloziN in Patients with SymptomATic obstructive And non-obstructive Hypertrophic CardioMyopathy (SONATA-HCM)” clinical trial evaluating sotagliflozin in patients with non-obstructive (nHCM) and obstructive (oHCM) hypertrophic cardiomyopathy.
The study substantially exceeded its enrollment target of 500 patients across more than 130 sites in 20 countries. The primary efficacy endpoint will assess improvement in symptoms for the entire population (nHCM and oHCM). The final study population included a substantial majority of patients with non-obstructive HCM, providing a robust opportunity to evaluate sotagliflozin in a patient group for whom effective treatment options remain limited, as well as a meaningful cohort of patients with obstructive HCM. Lexicon believes the final study population will enable a thorough assessment of sotagliflozin's potential across the spectrum of symptomatic HCM. Topline results are anticipated in the first quarter of 2027.
“Completion of patient enrollment in SONATA-HCM marks an important milestone for patients living with the symptoms of HCM, a chronic, progressive disease,” said Craig Granowitz, M.D., Ph.D., Lexicon’s senior vice president and chief medical officer. “We believe that sotagliflozin, a dual SGLT1 and SGLT2 inhibitor with a unique mechanism of action as compared to currently available treatments, has the potential to be a differentiated option for symptomatic HCM patients. We look forward to sharing topline results in the first quarter of 2027.”
SONATA-HCM is the only ongoing Phase 3 study in both non-obstructive and obstructive HCM and is the largest Phase 3 study including both nHCM and oHCM to date. SONATA-HCM is a randomized, double-blind, placebo-controlled, multinational trial that is evaluating the efficacy of sotagliflozin on symptoms, function, and other patient-reported outcomes, as well as safety, in patients with symptomatic HCM. The primary efficacy endpoint is improvement in symptoms, as measured by change from baseline to week 26 in the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ CSS). Patients with symptomatic HCM on a stable dose of guideline-directed therapy for HCM, including cardiac myosin inhibitors, were permitted to enroll in the study depending on certain criteria.
“For patients living with hypertrophic cardiomyopathy, there remains a significant need for additional treatment options that can help address persistent symptoms and improve daily function,” said Sharlene M. Day, M.D., co-principal investigator for SONATA-HCM, Presidential Professor, Director of Translational Research of the Penn Cardiovascular Institute, University of Pennsylvania. “Having a well-tolerated medication with a distinct mechanism of action that can complement other therapies would be an important advance for physicians and patients.”
“Completing enrollment in SONATA-HCM is a major achievement for the HCM community and reflects the commitment of investigators, study teams and participants,” said Carolyn Y. Ho, M.D., co-principal investigator for SONATA-HCM, Professor of Medicine at Harvard Medical School and Medical Director of the Cardiovascular Genetics Center at Brigham and Women’s Hospital. “We are grateful to the patients involved in this trial, whose partnership is essential to advancing research and hopefully bringing a novel treatment option to people living with HCM.”
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 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 hypertrophic cardiomyopathy. 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. 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, 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. [email protected]
For Investor Inquiries:
Lisa DeFrancesco
Lexicon Pharmaceuticals, Inc. [email protected]
Lexicon posouvá sotagliflozin do fáze III u HCM, přičemž topline data čeká v 1. čtvrtletí 2027. Současně míří na opětovné podání NDA pro T1D v roce 2026.
Key Takeaways Lexicon is advancing sotagliflozin in a phase III HCM study, with top-line data expected in Q1 2027.Lexicon's Novo Nordisk-partnered LX9851 entered phase I in 2026, with milestone-payment potential.LXRX targets a 2026 T1D NDA resubmission for sotagliflozin, pending STENO1 & fulfillment of FDA requirements. Lexicon Pharmaceuticals (LXRX - Free Report) is advancing its cardiometabolic franchise, led by its sole marketed drug, sotagliflozin. Sotagliflozin, an oral inhibitor of sodium-glucose cotransporter types I and II (SGLT1 and SGLT2), has been marketed in the United States as Inpefa since 2023 to reduce the risk of cardiovascular death and heart failure in adults. Lexicon has granted Viatris (VTRS - Free Report) the rights to develop, seek regulatory approvals for and commercialize sotagliflozin in markets outside the United States and Europe.
The company’s top line comprises product revenues from Inpefa, licensing and milestone revenues from LX9851, its obesity-focused asset partnered with Novo Nordisk (NVO - Free Report) and royalties from a previously commercialized product, Xermelo.
In 2020, Lexicon sold its commercial rights to Xermelo under an asset purchase and sale agreement to TerSera Therapeutics, receiving upfront payments while retaining certain ongoing royalty and milestone payment rights on Xermelo from TerSera Therapeutics.
The company is entering a catalyst-rich period, with several potentially transformative milestones expected across its cardiometabolic pipeline over the next 12 months.
Year to date, LXRX shares have surged 74.8% against the industry’s 1.7% decline.
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Sotagliflozin Becomes a Multi-Indication Growth Asset for LXRXLexicon is actively pursuing label expansion opportunities for sotagliflozin beyond its current heart failure indication. The company is enrolling patients in the pivotal phase III SONATA-HCM study evaluating sotagliflozin in hypertrophic cardiomyopathy (HCM), a chronic and progressive heart disease characterized by abnormal thickening of the heart muscle. Enrollment is expected to be completed in mid-2026, with top-line data anticipated in the first quarter of 2027. Positive clinical data could substantially increase investor confidence in the long-term growth trajectory of the drug.
Beyond HCM, LXRX is also pursuing approval of sotagliflozin for glycemic control in adults with type I diabetes (T1D) and remains on track for potential new drug application (NDA) resubmission and regulatory approval in 2026, subject to the successful completion of the ongoing STENO1 study and fulfillment of FDA data requirements. If approved, the company will market the drug under the brand name Zynquista.
To remind investors, Lexicon received a complete response letter from the FDA in 2019, which expressed concerns regarding the risk of diabetic ketoacidosis, a potentially serious complication associated with SGLT inhibitor use in patients with T1D. The agency requested additional data to better characterize the drug's safety profile and demonstrate that the benefits outweigh the risks.
NVO-LXRX Licensing Agreement to Boost Cash PositionLexicon entered into a licensing agreement withNovo Nordisk in 2025,under which the latter is developing LXRX’s LX9851, a first-in-class oral small-molecule inhibitor of acyl-CoA synthetase 5 for obesity and associated metabolic disorders. NVO initiated a phase I study in March 2026, which is expected to be completed in the first quarter of 2027. Per the licensing agreement, Lexicon has already received $55 million in upfront and milestone payments and remains eligible for up to $1 billion in additional development, regulatory and commercial milestones, along with tiered royalties on future sales.
Lexicon’s Another Pipeline Asset on the MoveAnother pipeline asset of Lexicon is pilavapadin (LX9211), an investigational oral, non-opioid therapy for diabetic peripheral neuropathic pain (DPNP). Following FDA clearance, the company plans to advance the candidate into phase III development. The primary endpoint will be the change in average daily pain score. If approved, pilavapadin would be the first oral, non-opioid therapy approved for neuropathic pain in more than 20 years. Lexicon is exploring strategic partnership opportunities to support the therapy's global development and commercialization.
Lexicon highlighted encouraging preclinical findings in March, suggesting that pilavapadin may have potential as a novel oral treatment for spasticity associated with conditions such as multiple sclerosis and spinal cord injury.
LXRX's Zacks Rank & EstimatesLexicon currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Over the past 30 days, estimates for LXRX’s loss per share have remained unchanged at 17 cents for 2026 and 24 cents for 2027.
