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.