THE WOODLANDS, Texas, Sept. 01, 2026 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that company management will present at three upcoming investor conferences taking place in New York, NY:
Citi 2026 Biopharma Back to School Conference
September 9, 2026, 11:20–11:55 AM (Eastern Time)
2026 Cantor Global Healthcare Conference
September 10, 2026, 3:20–3:50 PM (Eastern Time)
H.C. Wainwright 28th Annual Global Investment Conference
September 14, 2026, 9:00–9:30 AM (Eastern Time)
The live events and replays of the presentations can be accessed via the Events page on the company’s website at https://investors.lexpharma.com/.
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.
For Media Inquiries:
Dave Belian
Lexicon Pharmaceuticals, Inc. [email protected]
For Investor Inquiries:
Lisa DeFrancesco
Lexicon Pharmaceuticals, Inc. [email protected]
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.
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 (LXRX) is nearing multiple potential value-transforming events for sotagliflozin, and the shares have been strong since my last update. Sotagliflozin, targeting HCM and T1D, is the primary value driver; the pivotal SONATA-HCM Phase III readout is expected in 2027, and an NDA re-filing for T1D before year-end. Regulatory and commercialization risks arguably outweigh clinical risk, especially for T1D, as the company would have to commit considerable resources to commercialization to maximize the value of sotagliflozin.
Lexicon Pharmaceuticals NASDAQ: LXRX reported a wider second-quarter loss as revenue declined sharply from the prior-year period, while the company highlighted completed enrollment in its Phase III SONATA-HCM trial and outlined plans to resubmit a new drug application for ZYNQUISTA in type 1 diabetes during the fourth quarter.
Total revenue for the quarter ended June 30 was $0.7 million, compared with $28.9 million a year earlier. Second-quarter 2026 revenue represented net sales of INPEFA, while the prior-year quarter included $27.5 million of licensing revenue related to the company’s agreement with Novo Nordisk, in addition to INPEFA sales.
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Lexicon recorded a net loss of $31.8 million, or $0.07 per share, compared with net income of $3.3 million, or $0.01 per share, in the second quarter of 2025. The 2026 loss included a $4.3 million loss on early debt extinguishment associated with the repayment of term loans from Oxford Finance. Non-cash stock-based compensation expense was $3.3 million, compared with $3.2 million a year earlier.
SONATA-HCM Enrollment Completed Chief Executive Officer Mike Exton said Lexicon completed enrollment in SONATA-HCM, a Phase III study evaluating sotagliflozin in patients with hypertrophic cardiomyopathy, or HCM. The company said the study was significantly over-enrolled and described it as the largest Phase III study to date involving both obstructive and non-obstructive HCM.
Lexicon expects to report top-line results from the trial in the first quarter of 2027. The study’s primary efficacy endpoint is the change from baseline to week 26 in the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score, or KCCQ-CSS, across the overall study population.
Chief Medical Officer Craig Granowitz said the trial enrolled a substantial majority of patients with non-obstructive HCM, a population for which the company said treatment options remain limited, along with a meaningful cohort of obstructive HCM patients. Patients receiving stable guideline-directed HCM therapy, including cardiac myosin inhibitors, were permitted to enroll.
During the question-and-answer session, Granowitz said the trial is powered for the combined obstructive and non-obstructive population. He added that the over-enrollment increased management’s confidence in the study’s ability to assess the primary endpoint and that the company expects sufficient obstructive-HCM enrollment to evaluate results in both groups.
Exton said Lexicon views sotagliflozin as potentially usable either alone or alongside cardiac myosin inhibitors, though any future commercial positioning would depend on clinical and regulatory outcomes.
ZYNQUISTA Resubmission Targeted for Fourth Quarter Lexicon said the STENO-1 study, an open-label investigator-initiated study being conducted by the Steno Diabetes Center in Denmark, is expected to reach the patient-exposure level requested by the U.S. Food and Drug Administration by the end of August.
The FDA had requested a prospective study, adequate patient exposure and diabetic ketoacidosis, or DKA, rates below those seen in Lexicon’s earlier clinical trials to support resubmission of the ZYNQUISTA new drug application. Granowitz said DKA rates among sotagliflozin-treated patients in STENO-1 have been similar to the study’s standard-of-care group and below rates observed in Lexicon’s prior inTandem studies.
The company expects to complete the administrative work needed to collect and transfer patient-level data after the exposure threshold is reached. Lexicon currently anticipates an NDA resubmission during the fourth quarter, with Granowitz citing the end of October as the company’s current estimate.
In response to an analyst question on potential review timing, Exton said a six-month review following an end-of-October filing could place a decision in the second quarter of 2027. He noted, however, that the company intends to discuss whether a quicker review may be possible because the FDA has already received much of the information expected in the filing.
Outside the U.S. and Europe, Lexicon licensee Viatris has secured regulatory approvals for sotagliflozin in the United Arab Emirates and Bahrain. Viatris has also submitted applications in more than a dozen additional markets, including Saudi Arabia, Canada and Australia. Regulatory decisions in Canada and Australia are anticipated this year, according to Lexicon.
Earlier-Stage Programs and Financial Position Lexicon said LX9851, an oral small-molecule inhibitor of ACSL5 being developed for obesity, is in a Phase I study being conducted by Novo Nordisk. Lexicon has received two $10 million milestone payments under its license agreement with Novo Nordisk and said it could receive a third $10 million milestone later this year.
The company also said it is conducting preclinical work to explore additional potential indications for pilavapadin, which uses an AAK1 inhibition mechanism. Lexicon said it expects to share preclinical data as early as later this year.
Research and development expense rose to $17.4 million from $15.7 million a year earlier, driven by higher external costs related to the SONATA-HCM trial. Selling, general and administrative expense increased to $9.8 million from $9.4 million.
As of June 30, Lexicon had $190.6 million in cash equivalents and short-term investments, compared with $125.2 million in cash equivalents, short-term investments and restricted cash at the end of 2025.
In May, the company announced a $100 million debt facility with Hercules Capital. An initial $55 million tranche was funded at closing and used to repay the Oxford Finance facility. Lexicon may access an additional $20 million subject to clinical, regulatory and financial milestones, while a further $25 million tranche would require Hercules’ consent and meet specified timing requirements.
Lexicon reiterated its 2026 operating expense guidance of $100 million to $110 million, including expected research and development spending of $63 million to $68 million and selling, general and administrative spending of $37 million to $42 million. The company said it began targeted pre-commercial investments during the second quarter, including medical education, marketing preparation and market-access activities.
About Lexicon Pharmaceuticals (NASDAQ:LXRX)Lexicon Pharmaceuticals, Inc is a biopharmaceutical company focused on the discovery and development of novel medicines through its proprietary genome biology platform. By leveraging large-scale gene knockout libraries, the company identifies potential therapeutic targets and advances them through preclinical and clinical development. Lexicon's approach emphasizes the translation of genetic insights into targeted therapies for a range of human diseases.
The company's most advanced product is telotristat ethyl (sold under the brand name XERMELO), an oral treatment approved for the management of carcinoid syndrome diarrhea in patients inadequately 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 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.
Enrollment complete in Phase 3 SONATA-HCM study; top-line data expected Q1 2027 NDA resubmission activities for ZYNQUISTA ® in type 1 diabetes nearing completion Phase 1 clinical development of LX9851 ongoing by Novo Nordisk Conference call and webcast at 8:30 am ET THE WOODLANDS, Texas, Aug. 06, 2026 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today reported financial results for the three months ended June 30, 2026, and provided an update on key corporate milestones and accomplishments. “Lexicon continued to make strong progress during the second quarter, with the refinement of our strategy and sharpening of our focus beginning to bear fruit across our business,” said Mike Exton, Ph.D.
THE WOODLANDS, Texas, July 30, 2026 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced the Company will release its second quarter 2026 financial results on Thursday, August 6, 2026, prior to market open. Management will conduct a conference call and live webcast at 8:30 a.m. ET (7:30 a.m. CT) that day to discuss the financial results and to provide a business update.
Participants can access the conference call live via webcast on the Events page of the Company’s website at https://investors.lexpharma.com/. Participants who wish to ask a question may register here to receive dial-in numbers and a unique pin to join the call. An archived version of the webcast will be available on the Lexicon website.
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.
For Media Inquiries:
Dave Belian
Lexicon Pharmaceuticals, Inc. [email protected]
For Investor Inquiries:
Lisa DeFrancesco
Lexicon Pharmaceuticals, Inc. [email protected]
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]
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.
Oncotelic Therapeutics (OTCMKTS:OTLC - Get Free Report) and Lexicon Pharmaceuticals (NASDAQ: LXRX - Get Free Report) are both small-cap medical companies, but which is the superior investment? We will compare the two businesses based on the strength of their dividends, valuation, earnings, analyst recommendations, institutional ownership, profitability and risk. Profitability This table compares Oncotelic Therapeutics and
LX9851 is a first-in-class, oral non-incretin candidate being developed by Novo Nordisk for the treatment of obesity and associated metabolic disorders
Additional analyses from the SCORED and SOTA-P-CARDIA studies provide further evidence of benefits across patient subgroups potentially related to sotagliflozin's mechanism of action Additional analyses from the SCORED and SOTA-P-CARDIA studies provide further evidence of benefits across patient subgroups potentially related to sotagliflozin's mechanism of action
Lexicon Pharmaceuticals, Inc. (NASDAQ: LXRX - Get Free Report) shares crossed above its 200-day moving average during trading on Monday. The stock has a 200-day moving average of $1.39 and traded as high as $1.66. Lexicon Pharmaceuticals shares last traded at $1.51, with a volume of 3,357,632 shares trading hands. Wall Street Analysts Forecast Growth
Oral presentation highlights additional data from PROGRESS Phase 2b study of pilavapadin supporting selection of 10mg as optimal dose for Phase 3 development in DPNP
THE WOODLANDS, Texas, April 30, 2026 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced the Company will release its first quarter 2026 financial results on Thursday, May 7, 2026, prior to market open. Management will conduct a conference call and live webcast at 8:30 a.m. ET (7:30 a.m. CT) that day to discuss the financial results and to provide a business update.
THE WOODLANDS, Texas, May 04, 2026 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) announced today that it has entered into a loan facility with Hercules Capital, Inc. (NYSE: HTGC) that provides up to $100 million in borrowing capacity. Access to this non-dilutive capital provides Lexicon with greater financial flexibility through both an extended interest-only period and maturity date and the opportunity to further strengthen its balance sheet to support pivotal upcoming regulatory and commercial milestones.
SONATA-HCM anticipated to be fully enrolled mid-2026 Resubmission of NDA for ZYNQUISTA ® in type 1 diabetes anticipated mid-2026 with potential for approval this year Clinical development of LX9851 initiated by Novo Nordisk Capital raise, development milestone payments, and recent $100 million loan facility reinforce strong financial position Conference call and webcast at 8:30 am ET THE WOODLANDS, Texas, May 07, 2026 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today reported financial results for the three months ended March 31, 2026, and provided an update on key corporate milestones and accomplishments. “We have been intently focused on progressing our late and early-stage development pipeline in cardiometabolism and we are now well positioned to achieve several pivotal milestones as a result of those efforts,” said Mike Exton, Ph.D.
Lexicon Pharmaceuticals (LXRX) reported break-even quarterly earnings per share versus the Zacks Consensus Estimate of a loss of $0.04. This compares to a loss of $0.07 per share a year ago.
Lexicon Pharmaceuticals NASDAQ: LXRX executives highlighted progress across late-stage regulatory programs and efforts to bolster the company's financial position during the company's first-quarter 2026 earnings call on May 7.
THE WOODLANDS, Texas, May 12, 2026 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that Company management will participate in a fireside chat at the 4th Annual H.C. Wainwright BioConnect Investor Conference, taking place at the Nasdaq World Headquarters in New York City, on May 19, 2026.
THE WOODLANDS, Texas, May 28, 2026 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that Company management will participate in a fireside chat at the 2026 Jefferies Global Healthcare Conference on June 4, 2026 at 2:00 p.m. ET in New York City.
Presentations highlight consistent A1c reductions with sotagliflozin in type 1 diabetes and pharmacokinetics of pilavapadin across renal function groups Presentations highlight consistent A1c reductions with sotagliflozin in type 1 diabetes and pharmacokinetics of pilavapadin across renal function groups
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