06/15/2026 | Press release | Distributed by Public on 06/15/2026 06:15
Neumora Therapeutics Reports Data from Phase 3 KOASTAL Program
and Provides Business and Pipeline Update
Navacaprant did not achieve the primary endpoint in KOASTAL-2 or -3; Company to discontinue development of navacaprant
Advancing potential best-in-class programs with NMRA-511 in Alzheimer's disease
agitation, NMRA-898 in schizophrenia and NMRA-215 in cardiometabolic disease
Aligning organization to support initiation of multiple clinical studies, with cash runway into the third quarter of 2027
WATERTOWN, Mass., June 15, 2026 - Neumora Therapeutics, Inc. (Nasdaq: NMRA) a clinical-stage biopharmaceutical company with a therapeutics pipeline consisting of programs that target novel mechanisms of action for a broad range of underserved, prevalent diseases, today announced that the Phase 3 KOASTAL-2 and -3 studies of navacaprant for the treatment of major depressive disorder (MDD) did not achieve statistical significance on the primary or key secondary endpoints. The Company is discontinuing development of navacaprant as it continues to focus on advancing the rest of its best-in-class clinical portfolio.
"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," said Bill Aurora, Pharm.D., chief operating and development officer, Neumora.
"We remain excited about the best-in-class potential of our pipeline, which has advanced over the last six months with important data generated in each program," said Paul L. Berns, chairman and chief executive officer, Neumora. "We look forward to the key catalysts we expect for NMRA-511 in Alzheimer's disease agitation, NMRA-898 in schizophrenia and NMRA-215 in cardiometabolic disease over the next 12 months."
PIPELINE & BUSINESS UPDATE
Neumora continues to focus on advancing its potential best-in-class clinical portfolio with near-term anticipated milestones:
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NMRA-511 (V1a receptor antagonist, Alzheimer's disease agitation): |
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Complete multiple ascending dose cohort evaluating higher doses in healthy elderly volunteers in the fourth quarter of 2026. |
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Data from this study will inform dose selection for a Phase 2b dose ranging study that the Company plans to initiate by the end of 2026. |
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NMRA-898 (M4 positive allosteric modulator, schizophrenia): |
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Report data from the ongoing Phase 1 study in the second half of 2026. |
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NMRA-215 (NLRP3 inhibitor, obesity): |
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Complete repeat 13-week rat toxicology study mid-2026 and provide a program update with the Company's second quarter financial results in August 2026. |
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Initiate clinical studies by year end 2026. |
Neumora today announced that it will reduce its workforce by approximately 35%, which it expects to result in an annualized cost savings of approximately $10 million, partially offset by one-time restructuring costs of approximately $2 million. The Company expects its current cash and cash equivalents to provide runway into the third quarter of 2027, including multiple expected key clinical milestones.
KOASTAL SUMMARY RESULTS
The KOASTAL-2 and -3 studies enrolled 430 and 422 adult patients with MDD, respectively. In addition to these topline results, Neumora today announced results from pre-specified analyses of 426 patients from both studies who were enrolled following study optimizations in early 2025.
The primary endpoint of both KOASTAL-2 and -3 was change from baseline (CFB) to week 6 on the Montgomery-Åsberg Depression Rating Scale (MADRS). In the KOASTAL-2 study patients treated with navacaprant 80 mg (n = 217) demonstrated a similar CFB to those treated with placebo (n = 213) [-12.2 vs -12.0; least-squares mean difference (LSMD) = -0.3; p = 0.813]. In the KOASTAL-3 study patients treated with navacaprant 80 mg (n = 212) demonstrated a numerically lower CFB than those treated with placebo (n = 210) [-10.1 vs -10.8; LSMD = 0.7; p = 0.480]. In patients enrolled after study optimizations, patients treated with navacaprant (n=216) demonstrated a similar CFB to those treated with placebo (n = 210) [-12.1 vs -12.1; LSMD = 0.0; p = 0.976].
Navacaprant was shown to be safe and generally well tolerated with a safety profile consistent with prior studies.
About Neumora
Neumora Therapeutics, Inc. is a clinical-stage biopharmaceutical company founded to confront the greatest medical challenges of our generation by taking a fundamentally different approach to the way treatments for brain diseases are developed. Our therapeutic pipeline currently consists of programs that target novel mechanisms of action for a broad range of underserved, prevalent diseases. Neumora's mission is to redefine neuroscience drug development by bringing forward the next generation of novel therapies that offer improved treatment outcomes and quality of life for patients.