NMRA-511 / Neumora Therap - LARVOL DELTA

Neumora Therapeutics...executives highlighted new clinical-scale analyses for NMRA-511 in Alzheimer’s disease (AD) agitation and reviewed pipeline milestones during a presentation at the Guggenheim Emerging Outlook Biotech Summit 2026. (MarketBeat) - "The new data highlighted included: CGI-S (agitation): In the prespecified elevated-anxiety subgroup, NMRA-511 showed effect sizes of 0.78 at week six and 0.38 at week eight, with Pinto noting benefit continued accruing over time; NPI agitation/aggression: In the elevated-anxiety subgroup, NMRA-511 showed effect sizes of approximately 0.46 at week eight. Pinto said this measure is important for treatment goals such as delaying time to institutional care and reflects caregiver distress."

P1 data • Alzheimer's Disease

Neumora Therapeutics Highlights NMRA-511 AD Agitation Signal, Maps Higher-Dose Plan for 2026 (Yahoo Finance) - "Neumora plans a higher‑dose MAD cohort in 2026, pivotal studies in 2027, and a switch to a QD extended‑release formulation to extend IP to 2046...NMRA-215 (NLRP3 inhibitor) targets weight loss via sustained brain IC90 exposure and the company expects Q3 2026 biomarker data to show brain coverage and cardiometabolic effects, positioning the asset for GLP‑1 combination or maintenance strategies...Broader pipeline and timing: a mid‑2026 update is expected for the M4 PAMs, a combined readout for KOASTAL 2 & 3 is due in Q2 2026..."

Biomarker • Clinical data • New trial • Trial status • Alzheimer's Disease • Obesity

Neumora intends to advance the development of NMRA-511. (GlobeNewswire) - "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."

Clinical • New P2/3 trial • Alzheimer's Disease

Neumora Therapeutics Announces Positive Results from NMRA-511 Phase 1b Signal-Seeking Study in Alzheimer’s Disease Agitation (GlobeNewswire) - "Key findings from Part B of the Phase 1b study include...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."

P1 data • Alzheimer's Disease

Study to Evaluate the Effects of NMRA-323511 Among Healthy Elderly and Adults With Agitation Associated With Dementia Due to Alzheimer's Disease (clinicaltrials.gov) - P1 | N=96 | Completed | Sponsor: Neumora Therapeutics, Inc. | Recruiting ➔ Completed

Trial completion • Alzheimer's Disease • CNS Disorders • Dementia

NMRA-511: On Track to Report Data from Phase 1b Signal-seeking Study in Alzheimer’s Disease (AD) Agitation Around the End of 2025 (GlobeNewswire) - "Neumora is on track to report data from a Phase 1b signal-seeking study evaluating NMRA-511 as a treatment for AD agitation around the end of 2025."

P1 data • Alzheimer's Disease

Neumora Therapeutics Reports First Quarter 2025 Financial Results and Provides Business Update (GlobeNewswire) - "NMRA-511: On Track to Report Data from Phase 1b Study in Alzheimer’s Disease (AD) Agitation Around the End of 2025: Neumora is advancing a Phase 1b signal-seeking study evaluating NMRA-511 initially in healthy elderly adult participants in Part A and then people with agitation associated with dementia due to AD in Part B. The Company is on track to report data around the end of 2025."

P1 data • Trial status • Alzheimer's Disease

Neumora Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update (GlobeNewswire) - "Expect to progress next M4 positive allosteric modulator (PAM) program into the clinic by mid-2025...NMRA-511: On Track to Report Data from Phase 1b Study in Alzheimer’s Disease (AD) agitation by the end of 2025."

New trial • P1 data • Alzheimer's Disease

Neumora Therapeutics Reports Third Quarter 2024 Financial Results and Provides Business Update (GlobeNewswire) - "Neumora is advancing a Phase 1b study in investigating NMRA-511 initially in healthy elderly adult participants and then people with agitation associated with dementia due to AD. The Company expects to report data from this study in the second half of 2025."

P1 data • Alzheimer's Disease • CNS Disorders

Study to Evaluate the Effects of NMRA-323511 Among Healthy Elderly and Adults With Agitation Associated With Dementia Due to Alzheimer's Disease (clinicaltrials.gov) - P1 | N=96 | Recruiting | Sponsor: Neumora Therapeutics, Inc.

New P1 trial • Alzheimer's Disease • CNS Disorders • Dementia

Neumora Therapeutics Announces Initiation of Phase 1b Study of NMRA-511 for Treatment of Alzheimer’s Disease Agitation (GlobeNewswire) - "Neumora Therapeutics, Inc...today announced the initiation of a Phase 1b study evaluating NMRA-511 for the treatment of agitation associated with dementia due to Alzheimer’s disease (AD)...The Phase 1b study will investigate NMRA-511 initially in healthy elderly adult participants and then people with agitation associated with dementia due to AD...The primary endpoint of this signal-seeking study is change from baseline to Week 8 on the Cohen-Mansfield Agitation Inventory total score. Neumora expects to report topline data from this Phase 1b study in the second half of 2025."

New P1 trial • P1 data • Alzheimer's Disease • CNS Disorders

NMRA-511, a Novel Vasopressin 1a (V1a) Receptor Antagonist Reduces Threat Behaviors in Marmosets and Alters EEG Power Spectra Similarly in Marmosets and Humans (ACNP 2022) - "Oral administration of the V1a antagonist NMRA-511 produced anxiolytic-like activity without sedation in the marmoset threat test. The same dose of NMRA-511 (10 mg/kg) that reduced anxiety in the marmoset demonstrated increased relative power in the alpha and theta spectral bands with trends in the beta band in this species. Furthermore, using phEEG as a translatable biomarker, NMRA-511 was evaluated in a healthy control population and demonstrated similar changes in alpha and theta power and trends in the beta band as were observed in the marmoset."

CNS Disorders • Mood Disorders • Psychiatry