Neumora Therapeutics Announces Positive Results from NMRA-511 Phase 1b Signal-Seeking Study in Alzheimer’s Disease Agitation

Rhea-AI Summary

Neumora Therapeutics (NASDAQ: NMRA) reported positive Phase 1b signal-seeking results for NMRA-511 in Alzheimer’s disease agitation on Jan 5, 2026. Key findings: a reported 15.7-point mean reduction on CMAI total score, larger placebo-adjusted improvements in a pre-specified elevated-anxiety subgroup (placebo-adjusted -7.6 at Week 6, -5.6 at Week 8; Cohen’s d 0.51–0.64), and a favorable tolerability and safety profile with 2.5% discontinuations due to TEAEs. The study was a signal-seeking, not powered for statistical significance. Next steps: multiple ascending dose expansion and formulation work for once-daily extended-release dosing in 2026.

Positive

• Mean CMAI reduction of 15.7 points
• Elevated-anxiety subgroup placebo-adjusted CMAI -7.6 at Week 6
• Cohen’s d effect size 0.51–0.64 in elevated-anxiety patients
• Low treatment discontinuation rate of 2.5%

Negative

• Phase 1b was a signal-seeking study not powered for statistical significance
• Small efficacy dataset: 71 subjects in modified analysis set and 36 in elevated-anxiety subgroup
• Common adverse events included hyponatremia, dizziness, nausea among others

News Market Reaction

-1.51% 5.0x vol

36 alerts

-1.51% News Effect

+21.0% Peak Tracked

-19.4% Trough Tracked

-$5M Valuation Impact

$344M Market Cap

5.0x Rel. Volume

On the day this news was published, NMRA declined 1.51%, reflecting a mild negative market reaction. Argus tracked a peak move of +21.0% during that session. Argus tracked a trough of -19.4% from its starting point during tracking. Our momentum scanner triggered 36 alerts that day, indicating elevated trading interest and price volatility. This price movement removed approximately $5M from the company's valuation, bringing the market cap to $344M at that time. Trading volume was very high at 5.0x the daily average, suggesting heavy selling pressure.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

CMAI reduction: 15.7-point reduction Dose level: 20 mg BID Efficacy set size: 71 patients +5 more

8 metrics

CMAI reduction 15.7-point reduction Mean CMAI total score change in Phase 1b AD agitation study

Dose level 20 mg BID NMRA-511 dosing in Part B of Phase 1b AD agitation study

Efficacy set size 71 patients Modified analysis set (MASi) in Phase 1b Part B

Elevated anxiety subgroup 36 patients Pre-specified elevated anxiety population (RAID score ≥12)

Placebo-adjusted change MAS -2.6 / -2.1 CMAI CMAI total score at Weeks 6 and 8, MAS population

Effect size MAS Cohen’s d 0.20–0.23 Effect size range on CMAI in MAS population

Placebo-adjusted change anxiety -7.6 / -5.6 CMAI CMAI total score at Weeks 6 and 8, elevated anxiety group

TEAE discontinuations 2.5% Treatment discontinuations due to TEAEs in Phase 1b

Market Reality Check

Price: $1.96 Vol: Volume 1,981,604 is 2.28x...

high vol

$1.96 Last Close

Volume Volume 1,981,604 is 2.28x the 20-day average of 869,670, indicating elevated trading activity ahead of this news. high

Technical Shares at $1.66 are trading above the 200-day MA of $1.51, despite a -7.26% move over 24h.

Peers on Argus

Biotech peers showed mixed moves: ANNX -8.04%, VNDA -5.5%, CADL -5.23%, AVIR -2....

Biotech peers showed mixed moves: ANNX -8.04%, VNDA -5.5%, CADL -5.23%, AVIR -2.25%, while TNXP +1.85%. NMRA’s -7.26% decline with strong volume looks more stock-specific than a uniform sector reaction.

Historical Context

5 past events · Latest: Nov 06 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Nov 06	Earnings and update	Positive	-1.5%	Reported Q3 2025 results with cash runway into 2027 and pipeline milestones.
Nov 03	Conference participation	Neutral	-0.3%	Announced November 2025 participation in two healthcare investor conferences.
Oct 27	Clinical trial start	Positive	+2.3%	Initiated Phase 1 SAD/MAD study of NMRA-898 for neuropsychiatric indications.
Oct 27	Preclinical obesity data	Positive	+2.3%	Announced class-leading weight loss data for NMRA-215 in obesity models.
Oct 01	R&D day announcement	Positive	-2.2%	Planned virtual R&D Day highlighting seven programs, including NMRA-511 Phase 1b data.

Pattern Detected

Positive pipeline or event updates have often seen muted or negative next-day price reactions, with only some R&D-style announcements aligning positively.

Recent Company History

Over the past few months, Neumora has focused on advancing its CNS pipeline and strengthening its balance sheet. On Oct 27, 2025, it reported positive preclinical weight-loss data for NMRA-215 and initiated a Phase 1 study of NMRA-898, both followed by modest positive price reactions. Later, Q3 2025 financials highlighted $171.5M in cash and funding expected into 2027, yet the stock slipped. Today’s NMRA-511 Phase 1b results extend this pattern of clinically constructive news against a challenged share price.

Market Pulse Summary

This announcement highlights encouraging Phase 1b results for NMRA-511 in Alzheimer’s agitation, inc...

Analysis

This announcement highlights encouraging Phase 1b results for NMRA-511 in Alzheimer’s agitation, including a 15.7-point CMAI reduction and stronger effects in patients with elevated anxiety, alongside a favorable tolerability profile. It follows prior updates on NMRA‑215 and M4 programs, underscoring a broad CNS pipeline. Investors may watch for the planned higher-dose multiple-ascending-dose study, extended-release formulation work, and a Phase 2/3 dose-ranging trial to further validate these findings.

Key Terms

phase 1b, vasopressin 1a receptor, cmai total score, cohen’s d, +4 more

8 terms

phase 1b medical

"today announced positive results from its Phase 1b signal-seeking study of NMRA-511"

"Phase 1b" is an early stage in testing a new medical treatment or vaccine, where it is given to a small group of people to evaluate its safety and determine the right dose. For investors, this phase signals progress in development, indicating the treatment is advancing through initial safety checks, which can influence expectations for future success and potential market impact.

vasopressin 1a receptor medical

"selective antagonist of the vasopressin 1a receptor (V1aR) met the goal"

A vasopressin 1a receptor is a protein on the surface of certain cells that acts like a lock for the hormone vasopressin; when the hormone binds, it triggers responses such as blood vessel tightening, water balance changes, or effects on behavior. Investors care because drugs that block or activate this receptor can treat conditions like low blood pressure, fluid disorders, or psychiatric symptoms, so progress in trials or regulatory approval can materially affect a company’s prospects.

cmai total score medical

"demonstrated a 15.7 reduction on mean CMAI total score, representing"

The CMAI total score is the combined numeric result from the Cohen‑Mansfield Agitation Inventory, a clinical checklist that rates how often a patient exhibits different agitated behaviors. Investors see it as a single summary measure of a drug or intervention’s effect on agitation in dementia studies—like a report card grade that reflects whether a treatment meaningfully calms patients, which can influence trial success, regulatory decisions and commercial prospects.

cohen’s d medical

"representing a Cohen’s d effect size range of 0.20 – 0.23."

Cohen’s d is a simple numerical measure of how large the difference is between two groups, calculated by taking the gap between their average results and scaling it by the typical spread of individual results. Investors use it to judge whether an observed change or treatment is meaningfully big or just a small blip — like saying two players differ by a full game versus a few minutes — which helps assess the real-world importance of trial results, strategy tests, or performance comparisons.

treatment emergent adverse events medical

"Treatment emergent adverse events (TEAEs) were typically mild to moderate"

Treatment emergent adverse events are any new or worsened medical problems that appear after a patient starts a drug or medical intervention during a clinical trial. Investors care because the number, severity, and frequency of these events influence safety profiles, regulatory approval chances, and market acceptance; think of them like unexpected problems that crop up after installing a software update—minor ones may be manageable, but serious or common issues can stall or derail the product.

extended-release formulation medical

"once-daily dosing via an extended-release formulation of NMRA-511 in 2026."

An extended-release formulation is a medicine designed to release its active ingredient slowly over an extended period instead of all at once, like a timed sprinkler that waters a lawn gradually rather than flooding it. For investors, it matters because this design can improve patient convenience and adherence, support premium pricing, extend commercial life versus immediate-release versions, and create different regulatory and competitive dynamics that affect sales and profitability.

single-ascending dose/multiple-ascending dose medical

"Phase 1 single-ascending dose/multiple-ascending dose (SAD/MAD) study of NMRA-898"

Single-ascending dose (SAD) and multiple-ascending dose (MAD) are early-stage clinical tests that gradually increase a drug’s dose to check safety and how the body handles it. SAD gives one increasing dose to different small groups like turning up a volume knob step by step, while MAD gives repeated doses over days to see effects of regular use. Investors watch these studies for safety signals, dosing guidance and early signs of effectiveness that shape development timelines and risk.

placebo-controlled medical

"randomized, double-blind, placebo-controlled, parallel-group cohort designed to evaluate"

"Placebo-controlled" describes a testing method where one group receives the actual treatment or intervention, while another group receives a harmless, inactive version called a placebo. This approach helps determine whether the real treatment has genuine effects beyond psychological expectations. For investors, understanding this ensures confidence that reported benefits are real and not influenced by bias or false perceptions.

AI-generated analysis. Not financial advice.

NMRA-511 demonstrated a 15.7 reduction on mean CMAI total score, representing a clinically meaningful effect 

NMRA-511 demonstrated unsurpassed clinical effect size on CMAI total score in a pre-specified population with elevated anxiety

NMRA-511 demonstrated a favorable tolerability and safety profile

Neumora plans to evaluate higher doses of NMRA-511 via initiation of a multiple ascending dose expansion cohort in 2026

Company to host conference call today at 8:00 am ET

WATERTOWN, Mass., Jan. 05, 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 positive results from its Phase 1b signal-seeking study of NMRA-511 in people with Alzheimer’s disease (AD) agitation. NMRA-511, an oral, highly potent, brain-penetrant and selective antagonist of the vasopressin 1a receptor (V1aR) met the goal of the Phase 1b study, demonstrating a clinically meaningful effect size in people with AD agitation. In the study, NMRA-511 demonstrated a favorable tolerability and safety profile with no reports of somnolence or sedation.

“The goal of this signal-seeking study was to investigate the clinical potential of NMRA-511 in AD agitation and to identify a clinical effect size to inform further development. It has achieved that goal, demonstrating a clinically meaningful and robust effect in a broad patient population. We are encouraged by these data, which demonstrate a clear clinical effect that NMRA-511 meaningfully improves agitation symptoms among people with AD agitation, and has an unsurpassed effect size among patients with higher levels of baseline anxiety, with a favorable safety and tolerability profile” said Bill Aurora, Pharm.D., chief operating and development officer, Neumora. “Anxiety is often an underlying symptom that is present early in the AD agitation disease course, and there is an unmet need for tolerable therapies that can reduce agitation and anxiety symptoms. We look forward to advancing the program and exploring higher doses of NMRA-511. Our deepest thanks go to the patients who participated in this study, their families, the dedicated investigators and others who contributed to the important work of developing better treatments for this devastating condition.”

“AD agitation is a common and distressing symptom in Alzheimer's dementia that can significantly impact the quality of life for both patients and caregivers. It is associated with increased morbidity and mortality and earlier placement in long-term care facilities. Existing treatment options are often limited by modest efficacy, tolerability and safety concerns, leaving vast unmet need for therapies that reduce agitation, and improve outcomes without significant adverse effects,” said Anton P. Porsteinsson, M.D., William B. and Sheila Konar Professor of Psychiatry, Neurology, Neuroscience, and Medicine; Director, Alzheimer's Disease Care, Research and Education Program (AD-CARE), University of Rochester School of Medicine and Dentistry. “The results of treatment with NMRA-511 are particularly encouraging, as they demonstrated clinically meaningful effects in agitation symptoms among people with AD agitation, and even more profound results among those with elevated anxiety – representing a significant number of treated patients. These results are particularly compelling given the favorable tolerability profile, and as they are clearly supported by the understood link between the vasopressin system and regulation of anxiety.”

PHASE 1b RESULTS SUMMARY

The Phase 1b study investigated NMRA-511 in healthy elderly adult participants (Part A) as well as people with agitation associated with dementia due to AD (Part B). Part A was a randomized, double-blind, placebo-controlled cohort designed to evaluate the safety, tolerability and pharmacokinetics of NMRA-511 in eight healthy elderly participants. Part B was a multicenter, randomized, double-blind, placebo-controlled, parallel-group cohort designed to evaluate the safety, tolerability, and efficacy of NMRA-511 20 mg twice-daily (BID) in 80 people with AD agitation. The Phase 1b study was designed as a signal-seeking study to demonstrate a clinical effect and was not powered for statistical significance.

Key findings from Part B of the Phase 1b study include:

• 71 patients were included in the efficacy analysis (the modified analysis set [MASⁱ]).
• 36 patients were included in the pre-specified sub-population of patients with elevated anxiety at baseline (Rating Anxiety in Dementia score ≥12).
• In the MAS, patients treated with NMRA-511 demonstrated a -2.6 and -2.1 placebo-adjusted change from baseline on CMAI total score at Weeks 6 and 8 respectively, representing a Cohen’s d effect size range of 0.20 – 0.23.
• In the elevated anxiety population, NMRA-511 demonstrated a -7.6 and -5.6 placebo-adjusted change from baseline on CMAI total score at Weeks 6 and 8 respectively, representing a Cohen’s d effect size range of 0.51 – 0.64.
• NMRA-511 demonstrate a favorable tolerability and safety profile. Treatment emergent adverse events (TEAEs) were typically mild to moderate in severity, and there were low treatment discontinuations due to TEAEs (2.5%).
  • The most common adverse effects (>5% in either treatment group) in the study were nasopharyngitis, urinary tract infection, anemia, arthralgia, diarrhea, dizziness, headache, hyponatremia, myalgia, nausea, vomiting and abdominal pain.

NEXT STEPS

Neumora intends to advance the development of NMRA-511. The following next steps are planned for the program:

• Initiate a multiple ascending dose extension study investigating higher doses of NMRA-511 in 2026.
• Formulation development to enable once-daily dosing via an extended-release formulation of NMRA-511 in 2026.
• Initiate a Phase 2/3 dose ranging study with NMRA-511.
  

Webcast Information
Neumora will host a conference call at 8:00 a.m. ET on January 5, 2026. Participants can register for the live webcast here. In addition, a replay of the conference call will be available on the events and presentations section of the Company’s website at www.neumoratx.com. A replay of the webcast will be available following the completion of the event and will be archived for up to 30 days.

About NMRA-511
NMRA-511 is a highly potent and selective, best-in-class investigational antagonist of the vasopressin 1a receptor (V1aR) that exhibited greater than 3,000-fold selectivity over the V1b and V2 receptors and approximately 300-fold selectivity over the oxytocin receptor in preclinical studies. The V1aR is known to play a role in regulation of aggression, affiliation, stress and anxiety response and several lines of evidence, and the Phase 1b data reported today, indicate that V1aR antagonists have therapeutic potential for reducing symptoms of agitation. Based on data available to date, Neumora believes NMRA-511 has the potential to be a promising novel medication for multiple neuropsychiatric disorders and neurodegenerative diseases across the spectrum of anxiety, aggression and stress.

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 seven 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 intention 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; NMRA-511’s potential to meaningfully improve agitation symptoms among people with AD agitation and efficacy among patients with higher levels of baseline anxiety and potential differentiation from standard of care; the therapeutic potential of V1aR antagonists for reducing symptoms of agitation; the timing, progress and plans for its therapeutic development programs, including advancement of the development of NMRA-511 ; 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 contract research organizations; 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 September 30, 2025, which was filed with the SEC on November 6, 2025. 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

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ⁱModified Analysis Set: 2 placebo patients excluded based on rater change driving outlier data (>3 standard deviations from the mean).

FAQ

What did Neumora announce about NMRA-511 on January 5, 2026 (NMRA)?

Neumora announced positive Phase 1b signal-seeking results for NMRA-511 showing a reported 15.7-point mean CMAI reduction and favorable tolerability.

How effective was NMRA-511 in patients with elevated anxiety in the NMRA Phase 1b study?

In the pre-specified elevated-anxiety subgroup, NMRA-511 showed placebo-adjusted CMAI changes of -7.6 at Week 6 and -5.6 at Week 8 with Cohen’s d 0.51–0.64.

What safety and tolerability outcomes were reported for NMRA-511 (NMRA)?

NMRA-511 had a reported favorable tolerability profile, common TEAEs listed, and a 2.5% discontinuation rate due to adverse events.

What are Neumora’s next steps for NMRA-511 after the January 5, 2026 update?

Planned next steps include a multiple ascending dose extension investigating higher doses and formulation work for once-daily extended-release dosing in 2026.

Was the NMRA-511 Phase 1b study designed to be statistically definitive for efficacy?

No — the study was described as a signal-seeking trial and was not powered for statistical significance.