{"id":983609,"date":"2026-07-22T11:57:53","date_gmt":"2026-07-22T15:57:53","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/lb-pharmaceuticals-announces-accelerated-timing-of-topline-results-from-the-phase-3-nova-2-trial-of-lb-102-in-schizophrenia\/"},"modified":"2026-07-22T11:57:53","modified_gmt":"2026-07-22T15:57:53","slug":"lb-pharmaceuticals-announces-accelerated-timing-of-topline-results-from-the-phase-3-nova-2-trial-of-lb-102-in-schizophrenia","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/lb-pharmaceuticals-announces-accelerated-timing-of-topline-results-from-the-phase-3-nova-2-trial-of-lb-102-in-schizophrenia\/","title":{"rendered":"LB Pharmaceuticals Announces Accelerated Timing of Topline Results from the Phase 3 NOVA-2 Trial of LB-102 in Schizophrenia"},"content":{"rendered":"
\n

NEW YORK, July 22, 2026 (GLOBE NEWSWIRE) — LB Pharmaceuticals Inc (\u201cLB Pharmaceuticals\u201d or the \u201cCompany\u201d) (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.\u00a0<\/p>\n

\u201cEnrollment 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 interest in LB-102 as a potential new treatment for schizophrenia. Based on the pace of enrollment since initiating NOVA-2, we now expect to report topline results in the first half of 2027, ahead of our prior guidance of the second half of 2027, and to schedule a pre-NDA meeting soon thereafter in the second half of 2027,\u201d said Heather Turner, Chief Executive Officer of LB Pharmaceuticals. \u201cWe remain well capitalized with a cash runway expected to fund operations into the second quarter of 2029 through multiple clinical readouts, with topline data from the Phase 2 ILLUMINATE-1 trial of LB-102 in bipolar depression expected in the first quarter of 2028, and from the Phase 2 trial of LB-102 in adjunctive MDD in the first half of 2029.\u201d<\/p>\n

\n About LB-102<\/strong>\n <\/p>\n

LB-102 is a novel,\u00a0once-daily,\u00a0orally administered\u00a0investigational\u00a0small molecule and potential first benzamide antipsychotic in the\u00a0United States\u00a0for the treatment of neuropsychiatric disorders.\u00a0A\u00a0methylated derivative of amisulpride,\u00a0a\u00a0widely used antipsychotic\u00a0outside the United States,\u00a0LB-102 was developed\u00a0to retain\u00a0amisulpride\u2019s benefits while addressing its limitations. LB-102 is a potent and selective antagonist of D2, D3, and\u00a05HT-7\u00a0receptors\u00a0with few off-target effects\u00a0and\u00a0broad\u00a0therapeutic\u00a0potential\u00a0across psychosis and mood disorders.\u00a0In early 2025, LB Pharmaceuticals announced positive data from a four-week placebo-controlled, double-blinded, Phase 2 trial in patients with acute schizophrenia.\u00a0In this\u00a0trial,\u00a0LB-102 demonstrated statistically significant benefit versus placebo at all doses studied,\u00a0including\u00a0rapid\u00a0onset of\u00a0effect at week 1\u00a0and sustained benefit\u00a0through the\u00a0endpoint\u00a0of the trial, a\u00a0potentially class-leading safety profile with low rates of EPS (including akathisia), minimal sedation and few GI side effects, alongside effects on\u00a0negative symptoms and\u00a0cognitive performance.\u00a0These data\u00a0underscore\u00a0LB-102\u2019s potential to address multiple\u00a0dimensions\u00a0of neuropsychiatric illness.\u00a0The pivotal Phase 3 NOVA-2\u00a0trial\u00a0of LB-102 for acute schizophrenia and\u00a0the Phase 2 ILLUMINATE-1 trial of LB-102 for bipolar 1 depression\u00a0are ongoing, and a Phase 2 trial of LB-102 in adjunctive treatment of MDD is planned.\u00a0Additional\u00a0expansion opportunities for LB-102 include\u00a0predominantly negative\u00a0symptoms of schizophrenia, Alzheimer\u2019s disease\u00a0psychosis\u00a0and agitation, as well as\u00a0other neuropsychiatric diseases.\u00a0<\/p>\n

\n About LB Pharmaceuticals<\/strong>\n <\/p>\n

LB Pharmaceuticals is a neuromedicines company dedicated to developing and commercializing high-impact therapies that address the multiple dimensions of underserved brain diseases. The Company is building a pipeline that leverages the broad therapeutic potential of its lead product candidate, LB-102, which the Company believes has the opportunity to be the first benzamide antipsychotic drug approved for neuropsychiatric disorders in the United States. LB-102, if approved, has the potential to become a mainstay of psychiatric practice by offering a balanced clinical activity and tolerability profile that provides a potentially attractive alternative to branded and generic therapeutics for the treatment of a broad range of neuropsychiatric diseases.<\/p>\n

\n Cautionary Note Regarding Forward-Looking Statements<\/strong>\n <\/p>\n

Statements contained in this press release regarding matters that are not historical facts are \u201cforward-looking statements\u201d within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Words such as \u201caim,\u201d \u201canticipate,\u201d \u201cassume,\u201d \u201cbelieve,\u201d \u201ccontemplate,\u201d \u201ccontinue,\u201d \u201ccould,\u201d \u201cdesign,\u201d \u201cdue,\u201d \u201cestimate,\u201d \u201cexpect,\u201d \u201cgoal,\u201d \u201cintend,\u201d \u201cmay,\u201d \u201cobjective,\u201d \u201cplan,\u201d \u201cpositioned,\u201d \u201cpotential,\u201d \u201cpredict,\u201d \u201cseek,\u201d \u201cshould,\u201d \u201ctarget,\u201d \u201cwill,\u201d \u201cwould\u201d or similar expressions are intended to identify forward-looking statements. All statements other than statements of historical facts contained in this press release are forward-looking statements. These forward-looking statements include, but are not limited to, statements concerning the expected clinical development and regulatory pathway and therapeutic benefits of LB-102; the design, objectives, initiation, timing, progress and results of clinical trials of LB-102, including the pivotal Phase 3 NOVA-2 trial in acute schizophrenia, our open label trial (NOVA-3), the Phase 2 ILLUMINATE-1 trial in bipolar 1 depression and the Phase 2 trial for the adjunctive treatment of MDD; and anticipated cash runway into the second quarter of 2029. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, among others: the Company\u2019s limited operating history and historical losses; the Company\u2019s ability to raise additional funding to complete the development and any commercialization of LB-102; the Company\u2019s dependence on the success of its lead product candidate, LB-102; the Company\u2019s ability to obtain regulatory approval of and successfully commercialize its product candidate; the early stages of clinical development of the Company\u2019s lead product candidate, LB-102; any undesirable side effects or other properties of the Company\u2019s product candidate; that the Company may be delayed in initiating, enrolling or completing any clinical trials; competition from third parties that are developing products for similar uses; the Company\u2019s ability to obtain, maintain and protect its intellectual property; and the Company\u2019s dependence on third parties in connection with manufacturing, clinical trials and preclinical studies.<\/p>\n

These and other risks are described more fully in the section titled \u201cRisk Factors\u201d in the Company\u2019s Quarterly Report on Form 10-Q for the quarter ended March 31, 2026 and its other documents to be subsequently filed with or furnished to the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except to the extent required by law, the Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.<\/p>\n

\n Media and Investor Contact<\/strong>:\u00a0
Ellen Rose
erose@lbpharma.us<\/a><\/p>\n

\"\"
\n
\n \"\"\n <\/div>\n

<\/div>\n","protected":false},"excerpt":{"rendered":"

NEW YORK, July 22, 2026 (GLOBE NEWSWIRE) — LB Pharmaceuticals Inc (\u201cLB Pharmaceuticals\u201d or the \u201cCompany\u201d) (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 … <\/p>\n

Continue reading “LB Pharmaceuticals Announces Accelerated Timing of Topline Results from the Phase 3 NOVA-2 Trial of LB-102 in Schizophrenia”<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-983609","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"\nLB Pharmaceuticals Announces Accelerated Timing of Topline Results from the Phase 3 NOVA-2 Trial of LB-102 in Schizophrenia - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/lb-pharmaceuticals-announces-accelerated-timing-of-topline-results-from-the-phase-3-nova-2-trial-of-lb-102-in-schizophrenia\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"LB Pharmaceuticals Announces Accelerated Timing of Topline Results from the Phase 3 NOVA-2 Trial of LB-102 in Schizophrenia - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"NEW YORK, July 22, 2026 (GLOBE NEWSWIRE) — LB Pharmaceuticals Inc (\u201cLB Pharmaceuticals\u201d or the \u201cCompany\u201d) (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. 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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. 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