Lexicon Pharmaceuticals Provides a Business and Pipeline Update at the 44th Annual J.P. Morgan Healthcare Conference
SONATA-HCM on track for enrollment completion in 2026 and topline data in 2027
$10 million milestone payment triggered from licensing agreement with Novo Nordisk for LX9851
Zynquista on track for NDA resubmission and potential approval in 2026
Company presentation January 15 at 12:00 p.m. PT (3:00 p.m. ET)
THE WOODLANDS, Texas, Jan. 12, 2026 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX) today announced a business and pipeline update at the 44th Annual J.P. Morgan Healthcare Conference taking place January 12-15, 2026 in San Francisco.
"As we look ahead to 2026, Lexicon stands at the threshold of multiple potential catalysts demonstrating the strength of our pipeline and our cardiometabolic expertise. We have pioneered entirely new classes of investigative treatments for critical unmet medical needs, and advanced them into late-stage development," said Mike Exton, Ph.D., Lexicon's chief executive officer and director. "We're executing on multiple fronts to deliver breakthrough therapies for patients. We believe our strategic R&D investments will translate into tangible progress during 2026, driving value for both our shareholders and the patient communities we serve."
"As a result of our efforts in 2025 to reduce our operating expenses and become increasingly efficient in our operations, we ended the year with a strong cash balance sufficient to support the advancement of our programs and achieve key milestones into 2027," said Scott Coiante, Lexicon's senior vice president and chief financial officer.
Business and Pipeline Highlights
Sotagliflozin for Hypertrophic Cardiomyopathy (HCM)
The SONATA-HCM pivotal Phase 3 study evaluating sotagliflozin in HCM remains on track
- The study is targeting enrollment of 500 patients with both obstructive and non-obstructive HCM, with anticipated enrollment completion in mid-2026. Topline results are anticipated in Q1 2027.
ZYNQUISTA® (sotagliflozin) for Type 1 Diabetes (T1D)
Lexicon remains on track for New Drug Application (NDA) resubmission in 2026 based on FDA feedback and additional clinical data from the STENO1 study
- Based on current STENO1 enrollment estimates, regulatory feedback from the U.S. Food and Drug Administration (FDA) supports a potential NDA resubmission and regulatory approval in 2026, if the patient exposure and safety data requirements identified by the FDA for STENO1 are achieved.
- STENO1 is a third-party funded, investigator-initiated study of sotagliflozin being conducted by the Steno Diabetes Center (Denmark).
- The FDA provided feedback that the STENO1 study appears to be of adequate design and employs sufficient data collection methods to provide viable evidence of the incidence of diabetic ketoacidosis (DKA) with adequate safety data, prior to its completion, to support review of a resubmission of the NDA for Zynquista as an adjunct to insulin for glycemic control in adults with T1D.
Pilavapadin for Neuropathic Pain
Lexicon and the FDA held a productive End-of-Phase 2 meeting in the fourth quarter of 2025
- Lexicon continues to advance partnership discussions to maximize the global potential of this investigative therapy.
- Significant unmet need exists for new, non-opioid alternatives to pain therapy with various efforts underway to prioritize new methods of pain relief, including the potential introduction of supportive legislation.
Global Commercial Progress and Strategic Partnerships
International Expansion of sotagliflozin program by Viatris
- Regulatory approval received in the United Arab Emirates (UAE) with commercial supply provided by Lexicon and regulatory applications submitted in several other markets including Canada, Australia and New Zealand in 2025.
- Additional regulatory submissions and approvals are expected throughout 2026 in key international markets.
Advancement of LX9851 (oral ACSL5 inhibitor) for Obesity by Novo Nordisk
- IND-enabling activities completed by Lexicon.
- $10 million milestone payment triggered in January, with potential for up to an additional $20 million in milestone payments in 2026.
- $45 million received from Novo Nordisk to date; up to $950 million in remaining potential milestones plus tiered royalties on net sales.
2025 Financial Update
- Lexicon ended 2025 with cash, investments and restricted cash of $125.2 million (unaudited), sufficient to support planned operations into 2027.
- Cash runway excludes the impact of milestone payments related to LX9851 and other non-dilutive capital opportunities related to pilavapadin.
Presentation at the J.P. Morgan Healthcare Conference
Mike Exton, Ph.D. Lexicon's chief executive officer and director, will present a company update on January 15, 12:00 p.m. PT (3:00 p.m. ET). Scott Coiante, Lexicon's chief financial officer, and Craig Granowitz, M.D., Ph.D., Lexicon's chief medical officer, will participate in Q&A.
The live event and replay of the presentations can be accessed via the Events page of 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. Through the Genome5000™ program, Lexicon's unique genomics target discovery platform, Lexicon scientists studied the role and function of nearly 5,000 genes and identified more than 100 protein targets with significant therapeutic potential in a range of diseases. Through the precise targeting of these proteins, Lexicon is pioneering the discovery and development of innovative medicines to safely and effectively treat disease. Lexicon has advanced multiple medicines to market and has a pipeline of promising drug candidates in discovery and clinical and preclinical development in heart failure, neuropathic pain, obesity, cardiology, diabetes and other indications. For additional information, please visit www.lexpharma.com.
Safe Harbor Statement
This press release contains "forward-looking statements," including statements relating to Lexicon's financial position and long-term outlook on its business, including the commercialization of its approved products and the clinical development of, regulatory filings for, and potential therapeutic and commercial potential of its drug candidates. In addition, this press release also contains forward looking statements relating to Lexicon's growth and future operating results, discovery, development and commercialization of products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. All forward-looking statements are based on management's current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including Lexicon's ability to meet its capital requirements, successfully commercialize its approved products, successfully conduct preclinical and clinical development and obtain necessary regulatory approvals of its other drug candidates on its anticipated timelines, achieve its operational objectives, obtain patent protection for its discoveries and establish strategic alliances, as well as additional factors relating to manufacturing, intellectual property rights, and the therapeutic or commercial value of its approved products and other drug candidates. Any of these risks, uncertainties and other factors may cause Lexicon's actual results to be materially different from any future results expressed or implied by such forward-looking statements. Information identifying such important factors is contained under "Risk Factors" in Lexicon's annual report on Form 10-K for the year ended December 31, 2024, as filed with the Securities and Exchange Commission. Lexicon undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.
For Investor and Media Inquiries:
Lisa DeFrancesco
Lexicon Pharmaceuticals, Inc.
[email protected]
