LB Pharmaceuticals moves up NOVA-2 schizophrenia trial readout to first half of 2027

LB Pharmaceuticals Inc announced on July 22, 2026 that based on enrollment projections, it now expects to report topline results from the pivotal Phase 3 NOVA-2 trial of LB-102 in schizophrenia patients in the first half of 2027, with a pre-NDA meeting with the FDA planned for the second half of 2027.¹ This is earlier than the company's prior guidance.

NOVA-2 is described as a pivotal Phase 3 multi-center, randomized, double-blind, placebo-controlled trial evaluating LB-102's efficacy and safety in schizophrenia, designed to enroll about 460 patients across 25 sites in the U.S.¹

CEO Heather Turner said enrollment pace since the trial began led the company to move its topline data expectation to the first half of 2027, ahead of prior second-half-2027 guidance, with a pre-NDA meeting to follow in the second half of 2027.¹ Turner also said the company's cash position is expected to fund operations into the second quarter of 2029, covering additional readouts including Phase 2 ILLUMINATE-1 data in bipolar depression in the first quarter of 2028 and Phase 2 data in adjunctive MDD in the first half of 2029.¹

LB-102 is described as a once-daily, oral investigational small molecule and potential first benzamide antipsychotic in the U.S., a methylated derivative of amisulpride designed to keep that drug's benefits while addressing its limitations.¹ In an earlier four-week Phase 2 trial, the company reported positive data in acute schizophrenia patients in early 2025, with LB-102 showing statistically significant improvement over placebo across all doses tested, an effect visible as early as week 1 that continued through the trial's endpoint, along with a favorable side-effect profile and effects on negative symptoms and cognition.¹