Neumora Therapeutics Reports Data from Phase 3 KOASTAL Program and Provides Business and Pipeline Update
Rhea-AI Summary
Neumora Therapeutics (Nasdaq: NMRA) reported that Phase 3 KOASTAL-2 and -3 studies of navacaprant in major depressive disorder did not meet primary or key secondary endpoints, and the company will discontinue navacaprant.
Neumora is advancing NMRA-511, NMRA-898 and NMRA-215, cutting its workforce by ~35%, targeting ~$10M annualized cost savings, and expects its cash runway to extend into the third quarter of 2027.
AI-generated analysis. Not financial advice.
Positive
- Advancing NMRA-511 with Phase 2b dose-ranging study planned by end of 2026
- Phase 1 data for NMRA-898 in schizophrenia expected in second half of 2026
- NMRA-215 clinical studies in obesity targeted to start by year end 2026
- Workforce reduction expected to generate about $10 million annualized cost savings
- Cash and cash equivalents expected to fund operations into the third quarter of 2027
Negative
- Navacaprant failed primary and key secondary endpoints in Phase 3 KOASTAL-2 and -3
- Company discontinuing navacaprant development for major depressive disorder
- Approximately 35% workforce reduction announced
- Restructuring expected to incur about $2 million in one-time costs
News Market Reaction – NMRA
On the day this news was published, NMRA declined 48.62%, reflecting a significant negative market reaction. Argus tracked a peak move of +45.6% during that session. Argus tracked a trough of -26.7% from its starting point during tracking. Our momentum scanner triggered 102 alerts that day, indicating very high trading interest and price volatility. This price movement removed approximately $312M from the company's valuation, bringing the market cap to $329.81M at that time. Trading volume was exceptionally heavy at 15.1x the daily average, suggesting significant selling pressure.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Peers on Argus
Biotech peers show mixed moves: TNXP +6.57%, CADL +4.01%, AVIR +2.98%, ANNX +0.21%, while VNDA -3.61%. Momentum scanner flagged LXEO up 7.06% without news, suggesting stock-specific drivers matter more than a broad sector trend for this headline.
Previous Clinical trial Reports
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Oct 27 | Phase 1 start NMRA-898 | Positive | +2.3% | Initiation of Phase 1 SAD/MAD study for NMRA-898 M4 PAM. |
| Jul 09 | Phase 1 start NMRA-861 | Positive | +13.1% | Phase 1 SAD/MAD initiation for NMRA-861 in schizophrenia. |
| Jun 20 | Phase 1b start NMRA-511 | Positive | -3.3% | Launch of Phase 1b NMRA-511 study in Alzheimer’s agitation. |
Past clinical-trial initiations for NMRA-511 and M4 assets often saw modestly positive price reactions, with one negative outlier.
Over the last year, Neumora’s key news flow around clinical trials has centered on early‑stage program initiations. On Jun 20, 2024, it started a Phase 1b study of NMRA‑511 for Alzheimer’s agitation, which saw a -3.28% move. In Jul 2025 and Oct 2025, it initiated Phase 1 studies for M4 modulators NMRA‑861 and NMRA‑898, with +13.12% and +2.28% reactions. Today’s Phase 3 navacaprant failure contrasts with those earlier, more optimistic trial launches.
Historical Comparison
Past clinical-trial headlines moved NMRA about 4.04% on average. Those were early-stage starts, while this update reports a Phase 3 failure and portfolio realignment.
Clinical news has progressed from Phase 1/1b starts for NMRA-511 and M4 assets toward later-stage KOASTAL Phase 3 readouts, with focus now shifting to NMRA-511, NMRA-898, and NMRA-215 after navacaprant discontinuation.
Regulatory & Risk Context
Market Pulse Summary
The stock dropped -48.6% in the session following this news. A negative reaction despite the company’s remaining pipeline fits the clearly negative Phase 3 outcome, with navacaprant failing primary and key secondary endpoints and being discontinued. The workforce reduction of 35% and one-time costs of about $2 million underscore restructuring pressure. Future sentiment may hinge on delivery of NMRA‑511, NMRA‑898 and NMRA‑215 milestones into 2026–2027.
Key Terms
phase 3 medical
major depressive disorder medical
montgomery-åsberg depression rating scale medical
least-squares mean difference technical
p = technical
v1a receptor antagonist medical
m4 positive allosteric modulator medical
nlrp3 inhibitor medical
AI-generated analysis. Not financial advice.
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 (GLOBE NEWSWIRE) -- 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:
- NMRA-511 (V1a receptor antagonist, Alzheimer’s disease agitation):
- Complete multiple ascending dose cohort evaluating higher doses in healthy elderly volunteers in the fourth quarter of 2026.
- 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.
- NMRA-898 (M4 positive allosteric modulator, schizophrenia):
- Report data from the ongoing Phase 1 study in the second half of 2026.
- NMRA-215 (NLRP3 inhibitor, obesity):
- 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.
- Initiate clinical studies by year end 2026.
Neumora today announced that it will reduce its workforce by approximately
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.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements about Neumora Therapeutics, Inc. (the “Company,” “we,” “us,” or “our”) within the meaning of the federal securities laws, including statements related to: Neumora’s mission 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; advancement towards milestones for potential best-in-class programs with NMRA-511 in Alzheimer’s disease agitation, NMRA-898 in schizophrenia and NMRA-215 in obesity; the timing, progress and plans for its therapeutic development programs, including the timing of clinical trial initiation and data readouts; support for continued development, and upcoming milestones and catalysts; the reduction in force and expectations regarding annualized cost savings and restructuring charges; expectations and projections regarding future operating results and financial performance, including the sufficiency of its cash resources and expectation of the timing of its cash runway; and other statements identified by words such as “could,” “expects,” “intends,” “may,” “plans,” “potential,” “should,” “will,” “would,” or similar expressions and the negatives of those terms. Other than statements of historical facts, all statements contained in this press release are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These statements are subject to risks and uncertainties that could cause the actual results to be materially different from the information expressed or implied by these forward-looking statements, including, among others: comparisons to efficacy results from other sponsors should be interpreted with caution due to differences in compounds, study designs, subject characteristics, and other factors that may limit direct comparability; the risks related to the inherent uncertainty of clinical drug development and unpredictability and lengthy process for obtaining regulatory approvals; risks related to the timely initiation and enrollment in our clinical trials; risks related to our reliance on third parties, including CROs; risks related to serious or undesirable side effects of our therapeutic candidates; risks related to our ability to utilize and protect our intellectual property rights; and other matters that could affect sufficiency of capital resources to fund operations. For a detailed discussion of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Neumora’s business in general, please refer to the risk factors identified in the Company’s filings with the Securities and Exchange Commission (SEC), including but not limited to its Quarterly Report on Form 10-Q for the quarter ended March 31, 2026 which was filed with the SEC on May 7, 2026. Forward-looking statements speak only as of the date hereof, and, except as required by law, Neumora undertakes no obligation to update or revise these forward-looking statements.
Neumora Contact:
Helen Rubinstein
617-402-5700
Helen.Rubinstein@neumoratx.com
