Lexicon Sets Q1 2027 Sotagliflozin Milestones as Q3 Loss Widens

Lexicon Pharmaceuticals said enrollment is complete in its pivotal Phase 3 SONATA-HCM trial of sotagliflozin, with topline results expected in the first quarter of 2027. The company is also preparing to resubmit the drug’s New Drug Application under the ZYNQUISTA name for type 1 diabetes during the same quarter, setting up two significant clinical and regulatory milestones as it continues to report losses and limited product sales.

The Woodlands, Texas-based biopharmaceutical company reported third-quarter 2026 revenue of $11.3 million, down from $14.2 million a year earlier. Revenue included a third $10 million milestone payment under Lexicon’s license agreement with Novo Nordisk and $1.2 million in net sales of heart-failure treatment INPEFA. Lexicon has received $30 million in milestone payments from Novo Nordisk during 2026.

The third-quarter net loss widened to $14.0 million from $12.8 million, although the loss per common share narrowed to $0.03 from $0.04. Research and development expenses declined to $16.2 million from $18.8 million, while selling, general and administrative expenses rose to $9.5 million from $7.6 million. Total operating expenses decreased to $25.7 million from $26.4 million.

Lexicon ended September with $183.2 million in cash, cash equivalents, short-term investments and restricted cash, up from $125.2 million at the end of 2025. Total debt was $51.9 million, compared with $54.0 million at year-end.

Sotagliflozin milestones move closer

The SONATA-HCM trial randomized 542 patients with symptomatic hypertrophic cardiomyopathy, exceeding its enrollment target and increasing the study’s statistical power, according to the presentation. The 26-week study compares 400 milligrams of sotagliflozin with placebo, with change in the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score as its primary endpoint.

Lexicon said the trial includes both obstructive and nonobstructive hypertrophic cardiomyopathy, with an emphasis on the nonobstructive population, for which no FDA-approved treatment is currently available. About 9% of participants were receiving background cardiac myosin inhibitor therapy, which the company said may support potential complementary positioning. Pre-commercial planning is underway ahead of the readout.

In type 1 diabetes, Lexicon said it has received the data package from the third-party STENO1 investigator-initiated study and expects to resubmit the ZYNQUISTA NDA in the first quarter of 2027. The presentation indicated that the prospective study achieved the patient-exposure threshold discussed with the FDA.

As of Aug. 30, 2026, diabetic ketoacidosis rates were approximately 1.0 per 100 patient-years in both the 496-patient sotagliflozin group and the 708-patient standard-of-care group. Lexicon said the STENO1 rate was comparable to the historical Danish rate and below those observed in its earlier inTandem studies. Approval remains subject to FDA review.

Outside the U.S., Viatris’ heart-failure launch of sotagliflozin is underway. The drug has been approved in the United Arab Emirates and Bahrain, and additional regulatory submissions have been made in markets outside the U.S. and Europe.

Earlier-stage pipeline advances

Novo Nordisk is conducting an ongoing Phase 1 study of obesity candidate LX9851. The program generated the three $10 million milestone payments received by Lexicon during 2026, and the presentation indicated that further milestones may be possible.

Lexicon also said pilavapadin has a clear regulatory path to Phase 3 pivotal studies in diabetic peripheral neuropathic pain, although its 2026 expense guidance excludes costs associated with those trials. The company is separately evaluating the candidate in preclinical studies for obesity and other non-pain indications. Presented preclinical data showed a 13.9% body-weight reduction with pilavapadin alone and a 31.1% reduction when combined with semaglutide by day 28, compared with a 25.5% reduction for semaglutide alone.

For full-year 2026, Lexicon expects operating expenses of $100 million to $110 million. That forecast includes $63 million to $68 million of R&D spending and $37 million to $42 million of SG&A expenses, including targeted investment in pre-commercial activities.

The company cautioned that its clinical timelines, regulatory plans, commercialization efforts and projected financial performance depend on current assumptions and remain subject to risks and uncertainties. Key upcoming events—including the SONATA-HCM results, the planned ZYNQUISTA resubmission and potential later-stage development decisions—may not occur on the anticipated schedule or produce the expected outcomes.