EX-99.1 2 d173035dex991.htm EX-99.1 EX-99.1 Exhibit 99.1 LB Pharmaceuticals Announces Accelerated Timing of Topline Results from the Phase 3 NOVA-2 Trial of LB-102 in Schizophrenia NEW YORK, July 22, 2026 (GLOBE NEWSWIRE) - LB Pharmaceuticals Inc (“LB Pharmaceuticals” or the “Company”) (Nasdaq: LBRX), a neuromedicines company dedicated to developing and commercializing high-impact therapies that address the multiple dimensions of underserved brain diseases, today announced that based on enrollment projections, it now expects to report topline results from the pivotal Phase 3 NOVA-2 clinical trial of LB-102 in patients with schizophrenia in the first half of 2027 and to schedule a pre-NDA meeting with the FDA thereafter in the second half of 2027. NOVA-2 is a pivotal Phase 3 multi-center, randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of LB-102 for the treatment of schizophrenia. The trial is designed to enroll approximately 460 patients across 25 sites in the U.S. “Enrollment in our pivotal Phase 3 NOVA-2 trial has been more rapid than we expected, which we believe is a reflection of both the strength of our execution and the level of …
Open exhibit ↗Current Report · Items 8.01, 9.01 · 8-K
LB Pharmaceuticals Inc
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Other Events
Item 8.01 Other Events. On July 22, 2026, LB Pharmaceuticals Inc (the “Company”) issued a press release announcing accelerated timing of topline results from the Phase 3 NOVA-2 clinical trial of LB-102 in schizophrenia. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and, other than the quotes contained therein, is incorporated herein by reference.
Company context
We are a late-stage biopharmaceutical company developing novel therapies for the treatment of a wide range of neuropsychiatric disorders including schizophrenia, bipolar depression, adjunctive treatment of major depressive disorder and other diseases. We are building a pipeline that leverages the broad therapeutic potential of our lead product candidate, LB-102, which we believe has the potential to be the first benzamide antipsychotic drug approved for neuropsychiatric disorders in the United States. LB-102 is currently in late-stage clinical development for schizophrenia and bipolar depression. We are also planning to conduct a Phase 2 clinical trial evaluating LB-102 as an adjunctive treatment in major depressive disorder, or MDD. LB-102 is a new chemical entity and a methylated derivative of amisulpride, a second-generation antipsychotic drug approved in over 50 countries, not including the United States, because the development and regulatory requirements of the U.S. Food and Drug Administration, or FDA, for amisulpride were incompatible with patent coverage on the drug. Amisulpride is a generic drug that has been extensively used in clinical practice following its initial approval in France in the 1980s, generating at least two million monthly prescriptions in 2023 in a subset of 16 continental European countries. Among these European prescriptions for amisulpride, our data suggest that approximately 60% are for schizophrenia and schizoaffective disorders, approximately
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