Lexicon completes SONATA-HCM enrollment, eyes ZYNQUISTA resubmission in Q1 2027

Lexicon Pharmaceuticals said on November 5, 2026 that it had completed enrollment in SONATA-HCM, a pivotal Phase 3 placebo-controlled study in patients with symptomatic obstructive and non-obstructive hypertrophic cardiomyopathy, enrolling a total of 542 patients across both subtypes and substantially exceeding its planned enrollment.¹ The company described baseline demographics as generally consistent with prior HCM studies, with both nHCM and oHCM patients represented and a mean baseline KCCQ-CSS score of 59.¹ Lexicon continues to expect topline results in the first quarter of 2027.¹

On the type 1 diabetes program, Lexicon said the STENO1 study, a third-party funded, investigator-initiated trial run by the STENO Diabetes Center in Denmark, has met the patient exposure and safety data requirements agreed upon with the FDA to support resubmission of the company's New Drug Application for ZYNQUISTA.¹ The company reported low rates of diabetic ketoacidosis comparable to standard of care in STENO1, which it said complements efficacy results from the Phase 3 inTandem program.¹ Lexicon said it is now completing data preparation and administrative work to support a resubmission it anticipates in the first quarter of 2027.¹

On pilavapadin, Lexicon said following the Phase 2 PROGRESS study results in 2025, the FDA raised no objections to advancing the drug into Phase 3, which the company said would consist of two placebo-controlled 12-week studies with two arms each comparing a 10 mg daily dose to placebo.¹ The planned primary endpoint would be change in average daily pain score from baseline to Week 12.¹

On finances, Lexicon reported $183.2 million in cash and investments as of September 30, 2026, up from $125.2 million in cash, investments and restricted cash at the end of 2025.¹ The increase reflected net proceeds of $96.2 million from a February 2026 stock sale, partly offset by cash used in operations.¹