{"success":true,"data":{"pressRelease":{"id":"63606","rtpr_id":"nGNX5YQpzD","ticker":"NMRA","exchange":"NASDAQ","all_tickers":["NMRA"],"title":"Neumora Therapeutics Reports Data from Phase 3 KOASTAL Program and Provides Business and Pipeline Update","author":"Globe Newswire","published_at":"2026-06-15T12:00:00.522Z","article_body":"Navacaprant did not achieve the primary endpoint in KOASTAL-2 or -3; Company\nto discontinue development of navacaprant\n\nAdvancing potential best-in-class programs with NMRA-511 in Alzheimer’s\ndisease agitation, NMRA-898 in schizophrenia and NMRA-215 in cardiometabolic\ndisease\n\nAligning organization to support initiation of multiple clinical studies, with\ncash runway into the third quarter of 2027\n\nWATERTOWN, Mass., June 15, 2026 (GLOBE NEWSWIRE) -- Neumora Therapeutics, Inc.\n(Nasdaq: NMRA) a clinical-stage biopharmaceutical company with a therapeutics\npipeline consisting of programs that target novel mechanisms of action for a\nbroad range of underserved, prevalent diseases, today announced that the Phase\n3 KOASTAL-2 and -3 studies of navacaprant for the treatment of major\ndepressive disorder (MDD) did not achieve statistical significance on the\nprimary or key secondary endpoints. The Company is discontinuing development\nof navacaprant as it continues to focus on advancing the rest of its\nbest-in-class clinical portfolio.\n\n“While we are disappointed with the results of the KOASTAL-2 and -3 studies,\nwe want to extend our gratitude to the patients, families, dedicated\ninvestigators, Neumora team and others who contributed meaningfully to the\nKOASTAL program,” said Bill Aurora, Pharm.D., chief operating and\ndevelopment officer, Neumora.\n\n“We remain excited about the best-in-class potential of our pipeline, which\nhas advanced over the last six months with important data generated in each\nprogram,” said Paul L. Berns, chairman and chief executive officer, Neumora.\n“We look forward to the key catalysts we expect for NMRA-511 in\nAlzheimer’s disease agitation, NMRA-898 in schizophrenia and NMRA-215 in\ncardiometabolic disease over the next 12 months.”\n\nPIPELINE & BUSINESS UPDATE\n\nNeumora continues to focus on advancing its potential best-in-class clinical\nportfolio with near-term anticipated milestones:\n* NMRA-511 (V1a receptor antagonist, Alzheimer’s disease agitation): *\nComplete multiple ascending dose cohort evaluating higher doses in healthy\nelderly volunteers in the fourth quarter of 2026.\n* Data from this study will inform dose selection for a Phase 2b dose ranging\nstudy that the Company plans to initiate by the end of 2026.\n \n* NMRA-898 (M4 positive allosteric modulator, schizophrenia): * Report data\nfrom the ongoing Phase 1 study in the second half of 2026.\n \n* NMRA-215 (NLRP3 inhibitor, obesity): * Complete repeat 13-week rat\ntoxicology study mid-2026 and provide a program update with the Company’s\nsecond quarter financial results in August 2026.\n* Initiate clinical studies by year end 2026.\nNeumora today announced that it will reduce its workforce by approximately\n35%, which it expects to result in an annualized cost savings of approximately\n$10 million, partially offset by one-time restructuring costs of approximately\n$2 million. The Company expects its current cash and cash equivalents to\nprovide runway into the third quarter of 2027, including multiple expected key\nclinical milestones.\n\nKOASTAL SUMMARY RESULTS\n\nThe KOASTAL-2 and -3 studies enrolled 430 and 422 adult patients with MDD,\nrespectively. In addition to these topline results, Neumora today announced\nresults from pre-specified analyses of 426 patients from both studies who were\nenrolled following study optimizations in early 2025.\n\nThe primary endpoint of both KOASTAL-2 and -3 was change from baseline (CFB)\nto week 6 on the Montgomery-Åsberg Depression Rating Scale (MADRS). In the\nKOASTAL-2 study, patients treated with navacaprant 80 mg (n = 217)\ndemonstrated a similar CFB to those treated with placebo (n = 213) [-12.2 vs\n-12.0; least-squares mean difference (LSMD) = -0.3; p = 0.813]. In the\nKOASTAL-3 study, patients treated with navacaprant 80 mg (n = 212)\ndemonstrated a numerically lower CFB than those treated with placebo (n = 210)\n[-10.1 vs -10.8; LSMD = 0.7; p = 0.480]. In patients enrolled after study\noptimizations, patients treated with navacaprant (n = 216) demonstrated a\nsimilar CFB to those treated with placebo (n = 210) [-12.1 vs -12.1; LSMD =\n0.0; p = 0.976].\n\nNavacaprant was shown to be safe and generally well tolerated with a safety\nprofile consistent with prior studies.\n\nAbout Neumora\nNeumora Therapeutics, Inc. is a clinical-stage biopharmaceutical company\nfounded to confront the greatest medical challenges of our generation by\ntaking a fundamentally different approach to the way treatments for brain\ndiseases are developed. Our therapeutic pipeline currently consists of\nprograms that target novel mechanisms of action for a broad range of\nunderserved, prevalent diseases. Neumora’s mission is to redefine\nneuroscience drug development by bringing forward the next generation of novel\ntherapies that offer improved treatment outcomes and quality of life for\npatients.\n\nCautionary Note Regarding Forward-Looking Statements\nThis press release contains forward-looking statements about Neumora\nTherapeutics, Inc. (the “Company,” “we,” “us,” or “our”)\nwithin the meaning of the federal securities laws, including statements\nrelated to: Neumora’s mission to redefine neuroscience drug development by\nbringing forward the next generation of novel therapies that offer improved\ntreatment outcomes and quality of life for patients; advancement towards\nmilestones for potential best-in-class programs with NMRA-511 in Alzheimer’s\ndisease agitation, NMRA-898 in schizophrenia and NMRA-215 in obesity; the\ntiming, progress and plans for its therapeutic development programs, including\nthe timing of clinical trial initiation and data readouts; support for\ncontinued development, and upcoming milestones and catalysts; the reduction in\nforce and expectations regarding annualized cost savings and restructuring\ncharges; expectations and projections regarding future operating results and\nfinancial performance, including the sufficiency of its cash resources and\nexpectation of the timing of its cash runway; and other statements identified\nby words such as “could,” “expects,” “intends,” “may,”\n“plans,” “potential,” “should,” “will,” “would,” or\nsimilar expressions and the negatives of those terms. Other than statements of\nhistorical facts, all statements contained in this press release are\nforward-looking statements within the meaning of the \"safe harbor\" provisions\nof the Private Securities Litigation Reform Act of 1995. These statements are\nsubject to risks and uncertainties that could cause the actual results to be\nmaterially different from the information expressed or implied by these\nforward-looking statements, including, among others: comparisons to efficacy\nresults from other sponsors should be interpreted with caution due to\ndifferences in compounds, study designs, subject characteristics, and other\nfactors that may limit direct comparability; the risks related to the inherent\nuncertainty of clinical drug development and unpredictability and lengthy\nprocess for obtaining regulatory approvals; risks related to the timely\ninitiation and enrollment in our clinical trials; risks related to our\nreliance on third parties, including CROs; risks related to serious or\nundesirable side effects of our therapeutic candidates; risks related to our\nability to utilize and protect our intellectual property rights; and other\nmatters that could affect sufficiency of capital resources to fund operations.\nFor a detailed discussion of the risks and uncertainties that could cause\nactual results to differ from those expressed in these forward-looking\nstatements, as well as risks relating to Neumora’s business in general,\nplease refer to the risk factors identified in the Company’s filings with\nthe Securities and Exchange Commission (SEC), including but not limited to its\nQuarterly Report on Form 10-Q for the quarter ended March 31, 2026 which was\nfiled with the SEC on May 7, 2026. Forward-looking statements speak only as of\nthe date hereof, and, except as required by law, Neumora undertakes no\nobligation to update or revise these forward-looking statements.\n\nNeumora Contact:\nHelen Rubinstein\n617-402-5700\nHelen.Rubinstein@neumoratx.com\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/48256578-6cd3-4332-bf9b-2f52cfa248b7)\n\n\n\nGlobeNewswire, Inc. 2026","article_body_html":"","raw_payload":{"data":{"id":"nGNX5YQpzD","title":"Neumora Therapeutics Reports Data from Phase 3 KOASTAL Program and Provides Business and Pipeline Update","author":"Globe Newswire","ticker":"NMRA","created":"2026-06-15T12:00:00.522Z","tickers":["NMRA"],"exchange":"NASDAQ","article_body":"Navacaprant did not achieve the primary endpoint in KOASTAL-2 or -3; Company\nto discontinue development of navacaprant\n\nAdvancing potential best-in-class programs with NMRA-511 in Alzheimer’s\ndisease agitation, NMRA-898 in schizophrenia and NMRA-215 in cardiometabolic\ndisease\n\nAligning organization to support initiation of multiple clinical studies, with\ncash runway into the third quarter of 2027\n\nWATERTOWN, Mass., June 15, 2026 (GLOBE NEWSWIRE) -- Neumora Therapeutics, Inc.\n(Nasdaq: NMRA) a clinical-stage biopharmaceutical company with a therapeutics\npipeline consisting of programs that target novel mechanisms of action for a\nbroad range of underserved, prevalent diseases, today announced that the Phase\n3 KOASTAL-2 and -3 studies of navacaprant for the treatment of major\ndepressive disorder (MDD) did not achieve statistical significance on the\nprimary or key secondary endpoints. The Company is discontinuing development\nof navacaprant as it continues to focus on advancing the rest of its\nbest-in-class clinical portfolio.\n\n“While we are disappointed with the results of the KOASTAL-2 and -3 studies,\nwe want to extend our gratitude to the patients, families, dedicated\ninvestigators, Neumora team and others who contributed meaningfully to the\nKOASTAL program,” said Bill Aurora, Pharm.D., chief operating and\ndevelopment officer, Neumora.\n\n“We remain excited about the best-in-class potential of our pipeline, which\nhas advanced over the last six months with important data generated in each\nprogram,” said Paul L. Berns, chairman and chief executive officer, Neumora.\n“We look forward to the key catalysts we expect for NMRA-511 in\nAlzheimer’s disease agitation, NMRA-898 in schizophrenia and NMRA-215 in\ncardiometabolic disease over the next 12 months.”\n\nPIPELINE & BUSINESS UPDATE\n\nNeumora continues to focus on advancing its potential best-in-class clinical\nportfolio with near-term anticipated milestones:\n* NMRA-511 (V1a receptor antagonist, Alzheimer’s disease agitation): *\nComplete multiple ascending dose cohort evaluating higher doses in healthy\nelderly volunteers in the fourth quarter of 2026.\n* Data from this study will inform dose selection for a Phase 2b dose ranging\nstudy that the Company plans to initiate by the end of 2026.\n \n* NMRA-898 (M4 positive allosteric modulator, schizophrenia): * Report data\nfrom the ongoing Phase 1 study in the second half of 2026.\n \n* NMRA-215 (NLRP3 inhibitor, obesity): * Complete repeat 13-week rat\ntoxicology study mid-2026 and provide a program update with the Company’s\nsecond quarter financial results in August 2026.\n* Initiate clinical studies by year end 2026.\nNeumora today announced that it will reduce its workforce by approximately\n35%, which it expects to result in an annualized cost savings of approximately\n$10 million, partially offset by one-time restructuring costs of approximately\n$2 million. The Company expects its current cash and cash equivalents to\nprovide runway into the third quarter of 2027, including multiple expected key\nclinical milestones.\n\nKOASTAL SUMMARY RESULTS\n\nThe KOASTAL-2 and -3 studies enrolled 430 and 422 adult patients with MDD,\nrespectively. In addition to these topline results, Neumora today announced\nresults from pre-specified analyses of 426 patients from both studies who were\nenrolled following study optimizations in early 2025.\n\nThe primary endpoint of both KOASTAL-2 and -3 was change from baseline (CFB)\nto week 6 on the Montgomery-Åsberg Depression Rating Scale (MADRS). In the\nKOASTAL-2 study, patients treated with navacaprant 80 mg (n = 217)\ndemonstrated a similar CFB to those treated with placebo (n = 213) [-12.2 vs\n-12.0; least-squares mean difference (LSMD) = -0.3; p = 0.813]. In the\nKOASTAL-3 study, patients treated with navacaprant 80 mg (n = 212)\ndemonstrated a numerically lower CFB than those treated with placebo (n = 210)\n[-10.1 vs -10.8; LSMD = 0.7; p = 0.480]. In patients enrolled after study\noptimizations, patients treated with navacaprant (n = 216) demonstrated a\nsimilar CFB to those treated with placebo (n = 210) [-12.1 vs -12.1; LSMD =\n0.0; p = 0.976].\n\nNavacaprant was shown to be safe and generally well tolerated with a safety\nprofile consistent with prior studies.\n\nAbout Neumora\nNeumora Therapeutics, Inc. is a clinical-stage biopharmaceutical company\nfounded to confront the greatest medical challenges of our generation by\ntaking a fundamentally different approach to the way treatments for brain\ndiseases are developed. Our therapeutic pipeline currently consists of\nprograms that target novel mechanisms of action for a broad range of\nunderserved, prevalent diseases. Neumora’s mission is to redefine\nneuroscience drug development by bringing forward the next generation of novel\ntherapies that offer improved treatment outcomes and quality of life for\npatients.\n\nCautionary Note Regarding Forward-Looking Statements\nThis press release contains forward-looking statements about Neumora\nTherapeutics, Inc. (the “Company,” “we,” “us,” or “our”)\nwithin the meaning of the federal securities laws, including statements\nrelated to: Neumora’s mission to redefine neuroscience drug development by\nbringing forward the next generation of novel therapies that offer improved\ntreatment outcomes and quality of life for patients; advancement towards\nmilestones for potential best-in-class programs with NMRA-511 in Alzheimer’s\ndisease agitation, NMRA-898 in schizophrenia and NMRA-215 in obesity; the\ntiming, progress and plans for its therapeutic development programs, including\nthe timing of clinical trial initiation and data readouts; support for\ncontinued development, and upcoming milestones and catalysts; the reduction in\nforce and expectations regarding annualized cost savings and restructuring\ncharges; expectations and projections regarding future operating results and\nfinancial performance, including the sufficiency of its cash resources and\nexpectation of the timing of its cash runway; and other statements identified\nby words such as “could,” “expects,” “intends,” “may,”\n“plans,” “potential,” “should,” “will,” “would,” or\nsimilar expressions and the negatives of those terms. Other than statements of\nhistorical facts, all statements contained in this press release are\nforward-looking statements within the meaning of the \"safe harbor\" provisions\nof the Private Securities Litigation Reform Act of 1995. These statements are\nsubject to risks and uncertainties that could cause the actual results to be\nmaterially different from the information expressed or implied by these\nforward-looking statements, including, among others: comparisons to efficacy\nresults from other sponsors should be interpreted with caution due to\ndifferences in compounds, study designs, subject characteristics, and other\nfactors that may limit direct comparability; the risks related to the inherent\nuncertainty of clinical drug development and unpredictability and lengthy\nprocess for obtaining regulatory approvals; risks related to the timely\ninitiation and enrollment in our clinical trials; risks related to our\nreliance on third parties, including CROs; risks related to serious or\nundesirable side effects of our therapeutic candidates; risks related to our\nability to utilize and protect our intellectual property rights; and other\nmatters that could affect sufficiency of capital resources to fund operations.\nFor a detailed discussion of the risks and uncertainties that could cause\nactual results to differ from those expressed in these forward-looking\nstatements, as well as risks relating to Neumora’s business in general,\nplease refer to the risk factors identified in the Company’s filings with\nthe Securities and Exchange Commission (SEC), including but not limited to its\nQuarterly Report on Form 10-Q for the quarter ended March 31, 2026 which was\nfiled with the SEC on May 7, 2026. Forward-looking statements speak only as of\nthe date hereof, and, except as required by law, Neumora undertakes no\nobligation to update or revise these forward-looking statements.\n\nNeumora Contact:\nHelen Rubinstein\n617-402-5700\nHelen.Rubinstein@neumoratx.com\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/48256578-6cd3-4332-bf9b-2f52cfa248b7)\n\n\n\nGlobeNewswire, Inc. 2026"},"type":"article","timestamp":"2026-06-15T12:00:01.473678273Z","server_sent_at_ms":1781524801473},"received_at":"2026-06-15T12:00:01.571Z","source_url":null},"analysis":{"id":"53031","press_release_id":"63606","analysis_json":{"industry":{"label":"Biotechnology","sector":"Health Care"},"redFlags":["Lead asset (navacaprant) failed Phase 3 and is being discontinued","35% workforce reduction indicates significant operational contraction","Remaining pipeline assets are in early clinical or pre-clinical stages (Phase 1/2 or toxicology)"],"eventType":"fda_rejection","narrative":"Neumora Therapeutics announced that its Phase 3 KOASTAL-2 and KOASTAL-3 studies of navacaprant for major depressive disorder failed to meet primary or key secondary endpoints.\n\nThe company is discontinuing development of navacaprant, its lead asset, citing the lack of statistical significance in both trials.\n\nTo align resources with its remaining pipeline, Neumora is reducing its workforce by approximately 35%, expecting $10 million in annualized savings offset by $2 million in one-time costs.\n\nManagement highlighted upcoming catalysts for its remaining programs: NMRA-511 in Alzheimer’s agitation, NMRA-898 in schizophrenia, and NMRA-215 in obesity, with cash runway extending into Q3 2027.","sentiment":"bearish","agentHooks":{"shouldPost":true,"suggestedAngle":"NMRA misses Phase 3 endpoints for lead MDD asset, cuts 35% of staff; pivot to earlier-stage pipeline."},"keyFigures":{"drugName":"navacaprant","phaseOfTrial":"Phase 3","customDimensions":{"cash_runway":"Q3 2027","koastal_2_p_value":0.813,"koastal_3_p_value":0.48,"koastal_2_enrollment":430,"koastal_3_enrollment":422,"annualized_cost_savings":"$10 million","workforce_reduction_pct":"35%","one_time_restructuring_costs":"$2 million"}},"quotedText":"While we are disappointed with the results of the KOASTAL-2 and -3 studies, we want to extend our gratitude to the patients, families, dedicated investigators, Neumora team and others who contributed meaningfully to the KOASTAL program","namedEntities":{"people":[{"name":"Bill Aurora","role":"Chief Operating and Development Officer"},{"name":"Paul L. Berns","role":"Chairman and Chief Executive Officer"},{"name":"Helen Rubinstein","role":"Investor Relations Contact"}],"products":["navacaprant","NMRA-511","NMRA-898","NMRA-215"],"companies":[{"name":"Neumora Therapeutics, Inc.","ticker":"NMRA"}],"dollarAmounts":[{"amount":"$10 million","context":"annualized cost savings from workforce reduction"},{"amount":"$2 million","context":"one-time restructuring costs"}]},"materialImpact":{"score":4,"reasoning":"Failure of two pivotal Phase 3 studies for the lead asset (navacaprant) in major depressive disorder, resulting in discontinuation of the program. This is a significant binary negative event for a clinical-stage biotech, compounded by a 35% workforce reduction."},"tickerRelevance":{"others":[],"primary":"NMRA"},"globalImportance":45,"audienceRelevance":35,"eventTypeSecondary":["restructuring","clinical_trial"],"importanceComponents":{"tickerTier":"small-cap","eventGravity":"high","sectorWeight":"high","householdBrandBoost":0,"marketCapAdjustment":"neutral","retailFavoriteBoost":0}},"event_type":"fda_rejection","event_type_secondary":["restructuring","clinical_trial"],"sentiment":"bearish","material_impact_score":4,"narrative":"Neumora Therapeutics announced that its Phase 3 KOASTAL-2 and KOASTAL-3 studies of navacaprant for major depressive disorder failed to meet primary or key secondary endpoints.\n\nThe company is discontinuing development of navacaprant, its lead asset, citing the lack of statistical significance in both trials.\n\nTo align resources with its remaining pipeline, Neumora is reducing its workforce by approximately 35%, expecting $10 million in annualized savings offset by $2 million in one-time costs.\n\nManagement highlighted upcoming catalysts for its remaining programs: NMRA-511 in Alzheimer’s agitation, NMRA-898 in schizophrenia, and NMRA-215 in obesity, with cash runway extending into Q3 2027.","key_figures":{"drugName":"navacaprant","phaseOfTrial":"Phase 3","customDimensions":{"cash_runway":"Q3 2027","koastal_2_p_value":0.813,"koastal_3_p_value":0.48,"koastal_2_enrollment":430,"koastal_3_enrollment":422,"annualized_cost_savings":"$10 million","workforce_reduction_pct":"35%","one_time_restructuring_costs":"$2 million"}},"named_entities":{"people":[{"name":"Bill Aurora","role":"Chief Operating and Development Officer"},{"name":"Paul L. Berns","role":"Chairman and Chief Executive Officer"},{"name":"Helen Rubinstein","role":"Investor Relations Contact"}],"products":["navacaprant","NMRA-511","NMRA-898","NMRA-215"],"companies":[{"name":"Neumora Therapeutics, Inc.","ticker":"NMRA"}],"dollarAmounts":[{"amount":"$10 million","context":"annualized cost savings from workforce reduction"},{"amount":"$2 million","context":"one-time restructuring costs"}]},"model_name":"qwen3_6_27b_awq","prompt_hash":"sha256:727b4b9429a443af","schema_hash":"sha256:05005c02d9cffac9","created_at":"2026-06-15T12:05:30.797Z","global_importance":45,"audience_relevance":35,"importance_components":{"tickerTier":"small-cap","eventGravity":"high","sectorWeight":"high","householdBrandBoost":0,"marketCapAdjustment":"neutral","retailFavoriteBoost":0}},"durationMs":31207,"modelName":"george-droid-qwen-72b"}}