LB Pharmaceuticals (LBRX) FDA Approvals $28.00 -0.03 (-0.11%) Closing price 04:00 PM EasternExtended Trading$29.05 +1.05 (+3.75%) As of 04:28 PM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Massive. Learn more. Add Compare Share Share FDA Events Stock AnalysisAnalyst ForecastsChartCompetitorsEarningsFDA EventsHeadlinesInsider TradesOwnershipSEC FilingsShort InterestTrendsBuy This Stock Upcoming FDA Events for LB Pharmaceuticals LB Pharmaceuticals (LBRX) has upcoming FDA regulatory milestones for LB-102. The table below outlines estimated target dates and event types for these pending regulatory actions. DrugTarget DateAnnouncement LB-102H2 2027Top-line dataLB Pharmaceuticals Inc announced that the Topline data expected in 2H 2027 (March 25, 2026) LB Pharmaceuticals' Drug in the FDA Approval ProcessThis section highlights FDA-related milestones and regulatory updates for drugs developed by LB Pharmaceuticals (LBRX). Over the past two years, LB Pharmaceuticals has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as LB-102. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. LB-102 FDA Regulatory Timeline and Events LB-102 is a drug developed by LB Pharmaceuticals for the following indication: In Patients With Bipolar Depression. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy. Publication - April 22,2026Publication Drug: LB-102Announced Date: April 22, 2026Indication: In Patients With Bipolar DepressionAnnouncementLB Pharmaceuticals Inc announced the publication in the Journal of the American Medical Association (JAMA) Psychiatry of its manuscript titled "Antipsychotic Efficacy and Safety of LB-102 in the Treatment of Adults with Acute Schizophrenia: A Phase 2 Randomized Clinical Trial."AI SummaryLB Pharmaceuticals announced that the Journal of the American Medical Association (JAMA) Psychiatry has published its manuscript titled "Antipsychotic Efficacy and Safety of LB-102 in the Treatment of Adults with Acute Schizophrenia: A Phase 2 Randomized Clinical Trial." The paper presents the Phase 2 randomized trial findings evaluating the efficacy and safety of LB-102 in adults with acute schizophrenia, offering peer-reviewed data on the drug’s clinical profile. LB-102 is now being tested in the pivotal Phase 3 NOVA-2 study, a six-week, double-blind, placebo-controlled trial planned to enroll about 460 patients at roughly 25 U.S. sites. Topline results from NOVA-2 are expected in the second half of 2027. If the Phase 3 data are positive, LB-102 could become the first benzamide approved for schizophrenia in the United States.Read AnnouncementData Presentation - March 27,2026Data Presentation Drug: LB-102Announced Date: March 27, 2026Indication: In Patients With Bipolar DepressionAnnouncement- LB Pharmaceuticals Inc announced the presentation of new data further evaluating the effects of LB-102 on cognitive performance in the Phase 2 NOVA-1 clinical trial in patients with acute schizophrenia.AI SummaryLB Pharmaceuticals announced it will present new data that further evaluates the effects of LB-102 on cognitive performance in the Phase 2 NOVA‑1 clinical trial. The trial enrolled patients experiencing acute schizophrenia and is focused on assessing whether LB-102 can affect thinking skills that are often impaired in this condition. The company said the new data add to the trial’s findings by specifically looking at cognition. While the announcement did not detail specific results or statistics, the presentation is meant to show how LB-102 performs on measures of cognitive functioning within the NOVA‑1 study population. These data are intended to inform LB Pharmaceuticals’ next steps in development and to help clinicians and researchers better understand LB-102’s effects on cognitive symptoms in acute schizophrenia. The company is expected to share additional details as they become available.Read AnnouncementTop-line data - March 25,2026Top-Line Data Drug: LB-102Announced Date: March 25, 2026Target Action Date: H2 2027Estimated Target Date Range: July 1, 2027 - December 31, 2027Indication: In Patients With Bipolar DepressionAnnouncementLB Pharmaceuticals Inc announced that the Topline data expected in 2H 2027AI SummaryLB Pharmaceuticals announced that topline data from its Phase 3 NOVA-2 trial of LB-102 are expected in the second half of 2027. NOVA-2 will enroll about 460 patients and the primary endpoint is change in PANSS total score at week 6. Secondary endpoints include measures of negative symptoms, cognitive performance, and assessments of safety and tolerability. LB-102 has the potential to be the first benzamide approved for schizophrenia in the U.S. The company also plans an open-label extension of about 900 patients, open to NOVA-2 completers and new enrollees, to characterize long-term safety and further study effects on negative symptoms and cognition. Investors and clinicians will watch the 2027 readout for clues about LB-102’s real-world potential and next steps.Read AnnouncementPivotal trial - March 25,2026Pivotal Trial Phase 3Drug: LB-102Announced Date: March 25, 2026Indication: In Patients With Bipolar DepressionAnnouncementLB Pharmaceuticals Inc announced the initiation of its pivotal Phase 3 trial (NOVA-2) evaluating the efficacy and safety of LB-102 as a treatment for schizophrenia.AI SummaryLB Pharmaceuticals announced the start of its pivotal Phase 3 NOVA-2 trial to test LB-102 as a treatment for schizophrenia. The trial will enroll about 460 patients and could lead to the first benzamide approved for schizophrenia in the U.S. The primary endpoint is change from baseline in PANSS total score at week 6. Secondary endpoints will assess negative symptoms, cognitive performance, and safety and tolerability. The company also plans an open-label extension of roughly 900 patients, allowing NOVA-2 completers and new patients to continue treatment while gathering long-term safety data and more information on negative symptoms and cognition. Topline results from NOVA-2 are expected in the second half of 2027. If data are positive, LB Pharmaceuticals expects to pursue regulatory discussions with the FDA toward potential approval.Read AnnouncementInitiation - January 26,2026Initiation Phase 2Drug: LB-102Announced Date: January 26, 2026Indication: In Patients With Bipolar DepressionAnnouncementLB Pharmaceuticals Inc announced the initiation of a Phase 2 trial evaluating the efficacy and safety of LB-102 in patients with bipolar depression. LAI SummaryLB Pharmaceuticals has started a Phase 2 trial to test the efficacy and safety of LB-102 in patients with bipolar depression. LB-102 is a once-daily oral investigational drug, a methylated derivative of amisulpride, that selectively blocks D2, D3 and 5HT7 receptors. The company positions it as a potential benzamide antipsychotic with limited off-target effects and a focus on tolerability. The ILLUMINATE-1 trial is a multicenter, randomized, double-blind, placebo-controlled study with fixed- and flexible-dose elements. About 320 adults with bipolar I depression will be enrolled at roughly 30 U.S. sites. Patients will be randomized 1:1 to LB-102 (25 mg or 50 mg once daily) or placebo for six weeks. The primary endpoint is the MADRS-10 score at week six, with the main analysis pooling both LB-102 doses versus placebo. Secondary measures include MADRS-6, CGI-BP, cognition, anhedonia, and safety/tolerability. Topline results are expected in the first quarter of 2028. The trial aims to address unmet needs such as faster onset, fewer side effects like sedation and EPS, and improving anhedonia and cognitive symptoms.Read Announcement LB Pharmaceuticals FDA Events - Frequently Asked Questions Has LB Pharmaceuticals received FDA approval? As of now, LB Pharmaceuticals (LBRX) has not received any FDA approvals for its therapy in the last two years. What drugs has LB Pharmaceuticals submitted to the FDA? In the past two years, LB Pharmaceuticals (LBRX) has reported FDA regulatory activity for LB-102. What is the most recent FDA event for LB Pharmaceuticals? The most recent FDA-related event for LB Pharmaceuticals occurred on April 22, 2026, involving LB-102. The update was categorized as "Publication," with the company reporting: "LB Pharmaceuticals Inc announced the publication in the Journal of the American Medical Association (JAMA) Psychiatry of its manuscript titled "Antipsychotic Efficacy and Safety of LB-102 in the Treatment of Adults with Acute Schizophrenia: A Phase 2 Randomized Clinical Trial."" What conditions do LB Pharmaceuticals' current drugs treat? Currently, LB Pharmaceuticals has one therapy (LB-102) targeting the following condition: In Patients With Bipolar Depression. More FDA Event Resources from MarketBeat FDA Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events Adagio Medical FDA EventsBioCardia FDA EventsCognition Therapeutics FDA EventsCorbus Pharmaceuticals FDA EventsPrecision BioSciences FDA EventsHUTCHMED FDA EventsEli Lilly and Company FDA EventsTeleflex FDA EventsBioMarin Pharmaceutical FDA EventsDiaMedica Therapeutics FDA EventsDyne Therapeutics FDA EventsGuardant Health FDA EventsLigand Pharmaceuticals FDA EventsMadrigal Pharmaceuticals FDA EventsMetaVia FDA Events FDA Event Stage Terminology & Abbreviation Guide NDA: New Drug Application ANDA: Abbreviated New Drug Application sNDA: Supplemental New Drug Application BLA: Biologics License Application sBLA: Supplemental Biologics License Application FDA Approved: Approved by the FDA EMA: European Medicines Agency CE Mark: European Union Certification NMPA: China National Medical Products Administration MHLW: Japanese Ministry of Health FDA Meeting: Consultation with FDA Pre-IND: Pre-Investigational New Drug Meeting Breakthrough Therapy: Special FDA designation for promising therapies Fast Track: Accelerated FDA approval pathway Orphan Drug: Designation for rare disease treatments RPD: Rare Pediatric Disease Designation RMAT: Regenerative Medicine Advanced Therapy DSMB Review: Data Safety Monitoring Board Review IDMC Review: Independent Data Monitoring Committee MAA: MHRA Marketing Authorization Application RTF: Refusal to File (Rejected Application) 510(k): FDA Clearance for Medical Devices Rolling Submission: Staggered regulatory review process Related Companies Erasca FDA Events Arcus Biosciences FDA Events Tango Therapeutics FDA Events Denali Therapeutics FDA Events Alumis FDA Events Beam Therapeutics FDA Events Dyne Therapeutics FDA Events Tarsus Pharmaceuticals FDA Events Vera Therapeutics FDA Events Arcutis Biotherapeutics FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare and Medical Stocks FDA progress for NASDAQ:LBRX last updated on 4/22/2026 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data. 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Publication - April 22,2026Publication Drug: LB-102Announced Date: April 22, 2026Indication: In Patients With Bipolar DepressionAnnouncementLB Pharmaceuticals Inc announced the publication in the Journal of the American Medical Association (JAMA) Psychiatry of its manuscript titled "Antipsychotic Efficacy and Safety of LB-102 in the Treatment of Adults with Acute Schizophrenia: A Phase 2 Randomized Clinical Trial."AI SummaryLB Pharmaceuticals announced that the Journal of the American Medical Association (JAMA) Psychiatry has published its manuscript titled "Antipsychotic Efficacy and Safety of LB-102 in the Treatment of Adults with Acute Schizophrenia: A Phase 2 Randomized Clinical Trial." The paper presents the Phase 2 randomized trial findings evaluating the efficacy and safety of LB-102 in adults with acute schizophrenia, offering peer-reviewed data on the drug’s clinical profile. LB-102 is now being tested in the pivotal Phase 3 NOVA-2 study, a six-week, double-blind, placebo-controlled trial planned to enroll about 460 patients at roughly 25 U.S. sites. Topline results from NOVA-2 are expected in the second half of 2027. If the Phase 3 data are positive, LB-102 could become the first benzamide approved for schizophrenia in the United States.Read Announcement
Data Presentation - March 27,2026Data Presentation Drug: LB-102Announced Date: March 27, 2026Indication: In Patients With Bipolar DepressionAnnouncement- LB Pharmaceuticals Inc announced the presentation of new data further evaluating the effects of LB-102 on cognitive performance in the Phase 2 NOVA-1 clinical trial in patients with acute schizophrenia.AI SummaryLB Pharmaceuticals announced it will present new data that further evaluates the effects of LB-102 on cognitive performance in the Phase 2 NOVA‑1 clinical trial. The trial enrolled patients experiencing acute schizophrenia and is focused on assessing whether LB-102 can affect thinking skills that are often impaired in this condition. The company said the new data add to the trial’s findings by specifically looking at cognition. While the announcement did not detail specific results or statistics, the presentation is meant to show how LB-102 performs on measures of cognitive functioning within the NOVA‑1 study population. These data are intended to inform LB Pharmaceuticals’ next steps in development and to help clinicians and researchers better understand LB-102’s effects on cognitive symptoms in acute schizophrenia. The company is expected to share additional details as they become available.Read Announcement
Top-line data - March 25,2026Top-Line Data Drug: LB-102Announced Date: March 25, 2026Target Action Date: H2 2027Estimated Target Date Range: July 1, 2027 - December 31, 2027Indication: In Patients With Bipolar DepressionAnnouncementLB Pharmaceuticals Inc announced that the Topline data expected in 2H 2027AI SummaryLB Pharmaceuticals announced that topline data from its Phase 3 NOVA-2 trial of LB-102 are expected in the second half of 2027. NOVA-2 will enroll about 460 patients and the primary endpoint is change in PANSS total score at week 6. Secondary endpoints include measures of negative symptoms, cognitive performance, and assessments of safety and tolerability. LB-102 has the potential to be the first benzamide approved for schizophrenia in the U.S. The company also plans an open-label extension of about 900 patients, open to NOVA-2 completers and new enrollees, to characterize long-term safety and further study effects on negative symptoms and cognition. Investors and clinicians will watch the 2027 readout for clues about LB-102’s real-world potential and next steps.Read Announcement
Pivotal trial - March 25,2026Pivotal Trial Phase 3Drug: LB-102Announced Date: March 25, 2026Indication: In Patients With Bipolar DepressionAnnouncementLB Pharmaceuticals Inc announced the initiation of its pivotal Phase 3 trial (NOVA-2) evaluating the efficacy and safety of LB-102 as a treatment for schizophrenia.AI SummaryLB Pharmaceuticals announced the start of its pivotal Phase 3 NOVA-2 trial to test LB-102 as a treatment for schizophrenia. The trial will enroll about 460 patients and could lead to the first benzamide approved for schizophrenia in the U.S. The primary endpoint is change from baseline in PANSS total score at week 6. Secondary endpoints will assess negative symptoms, cognitive performance, and safety and tolerability. The company also plans an open-label extension of roughly 900 patients, allowing NOVA-2 completers and new patients to continue treatment while gathering long-term safety data and more information on negative symptoms and cognition. Topline results from NOVA-2 are expected in the second half of 2027. If data are positive, LB Pharmaceuticals expects to pursue regulatory discussions with the FDA toward potential approval.Read Announcement
Initiation - January 26,2026Initiation Phase 2Drug: LB-102Announced Date: January 26, 2026Indication: In Patients With Bipolar DepressionAnnouncementLB Pharmaceuticals Inc announced the initiation of a Phase 2 trial evaluating the efficacy and safety of LB-102 in patients with bipolar depression. LAI SummaryLB Pharmaceuticals has started a Phase 2 trial to test the efficacy and safety of LB-102 in patients with bipolar depression. LB-102 is a once-daily oral investigational drug, a methylated derivative of amisulpride, that selectively blocks D2, D3 and 5HT7 receptors. The company positions it as a potential benzamide antipsychotic with limited off-target effects and a focus on tolerability. The ILLUMINATE-1 trial is a multicenter, randomized, double-blind, placebo-controlled study with fixed- and flexible-dose elements. About 320 adults with bipolar I depression will be enrolled at roughly 30 U.S. sites. Patients will be randomized 1:1 to LB-102 (25 mg or 50 mg once daily) or placebo for six weeks. The primary endpoint is the MADRS-10 score at week six, with the main analysis pooling both LB-102 doses versus placebo. Secondary measures include MADRS-6, CGI-BP, cognition, anhedonia, and safety/tolerability. Topline results are expected in the first quarter of 2028. The trial aims to address unmet needs such as faster onset, fewer side effects like sedation and EPS, and improving anhedonia and cognitive symptoms.Read Announcement
