Lexicon Posts $5.5M Q4 Revenue, Advances HCM Trial to 130 Sites and Plans 2026 Zynquista Resubmission
Lexicon’s Phase III SONATA-HCM trial has opened over 130 sites in about 20 countries, with enrollment above 50% and top-line results due Q1 2027. The company plans a 2026 NDA resubmission for Zynquista targeting year-end approval and reported $5.5 million in Q4 revenue.
1. Phase III SONATA-HCM Trial Progress
Lexicon’s Phase III registrational SONATA-HCM trial includes both obstructive and non-obstructive patients, has initiated over 130 sites across roughly 20 countries, and enrollment has surpassed 50%. The study uses the Kansas City Cardiomyopathy Questionnaire endpoint, with top-line results expected in the first quarter of 2027 and supporting investigator-initiated SOTA-CARDIA and SOTA-CROSS substudies.
2. Zynquista NDA Resubmission Plans
Lexicon plans to resubmit its NDA for Zynquista in type 1 diabetes in 2026, leveraging third-party Steno-1 trial data to meet FDA exposure and DKA rate criteria. Management expects a six-month review and potential regulatory approval before the end of 2026 based on pre-agreed safety thresholds.
3. Financial Performance and Milestone Achievements
Chief Financial Officer reported $5.5 million in Q4 2025 revenue and $49.8 million for the full year, alongside sharply lower operating expenses. The obesity candidate LX9851 triggered a $10 million milestone payment from Novo Nordisk with up to $20 million more possible in 2026, and pilavapadin received FDA clearance to advance into Phase III without additional preclinical studies.