Lexicon completes SONATA-HCM enrollment, keeps Q1 2027 data timeline

Lexicon Pharmaceuticals said on August 6, 2026 that enrollment has been completed in SONATA-HCM, a pivotal Phase 3 placebo-controlled study, substantially exceeding its enrollment target of 500 patients across both non-obstructive (nHCM) or obstructive HCM (oHCM).¹ The company said the primary efficacy endpoint will assess improvement in symptoms for the entire population, with the final study population including a substantial majority of patients with nHCM and a meaningful cohort of oHCM patients.¹ Lexicon reiterated that it continues to expect topline results in the first quarter of 2027.¹

On type 1 diabetes, Lexicon said the STENO1 investigator-initiated study is approaching the patient exposure and safety data thresholds the FDA previously identified as adequate to support an NDA resubmission for Zynquista, which the company anticipates in the fourth quarter of 2026 based on current data collection timing.¹ It added that safety data received to date from the open-label trial continue to support the resubmission.¹

For LX9851, licensed to Novo Nordisk, Lexicon noted Novo Nordisk initiated a Phase 1 study in March 2026 testing single and multiple ascending doses in overweight or obese patients, with the Phase 1 program expected to complete in the first quarter of 2027.¹

On financing, Lexicon reported $190.6 million in cash and investments as of June 30, 2026, compared with $125.2 million in cash, investments, and restricted cash as of December 31, 2025.¹ The increase reflected net proceeds of $96.2 million from a February 2026 sale of common and preferred stock.¹ Separately, in May 2026 Lexicon entered a $100 million loan facility with Hercules Capital, with an initial $55 million tranche funded at closing and used to repay its prior Oxford Finance facility.¹