Neumora outlines NMRA-511 next steps and sets March 30 financial update

Neumora Therapeutics said it plans to initiate and complete a multiple-ascending-dose extension cohort testing higher doses of NMRA-511 in 2026, then move into pivotal studies in 2027. The company also said it will host a conference call and live webcast at 8:00 a.m. ET on Monday, March 30, 2026, to report its fourth quarter and full year 2025 financial results and provide a business update.

The company shared additional data from a phase 1b “signal-seeking” study of NMRA-511 in Alzheimer’s disease agitation, following results previously disclosed last month. The study was not powered for statistical significance and was designed to estimate effect size to inform future development.

In a prespecified analysis of patients with elevated baseline anxiety, NMRA-511 produced a 20.1-point reduction on the Cohen-Mansfield Agitation Inventory total score at week eight, corresponding to a Cohen’s d effect size range of 0.51–0.64. The new data also included CGI-S (agitation), where in the prespecified elevated-anxiety subgroup NMRA-511 showed effect sizes of 0.78 at week six and 0.38 at week eight, and NPI agitation/aggression, where in the elevated-anxiety subgroup NMRA-511 showed effect sizes of approximately 0.46 at week eight.

The company said results were highly consistent across additional clinician- and caregiver-relevant scales. It also said the total study population was generally balanced except for baseline RAID anxiety scores, which favored placebo, and that it intends to balance and stratify for this element in future studies.

Neumora said it intends to transition from a twice-daily formulation to a once-daily extended-release formulation for pivotal studies, and stated this would extend intellectual property runway, moving an estimated composition-of-matter loss of exclusivity from 2042 to 2046. On dose selection and target engagement, the company said there is no ligand available to run formal PET receptor occupancy studies for V1a in humans, so occupancy estimates rely on modeling.

On safety, the company said it did not observe typical CNS tolerability issues such as headaches at a higher rate on active drug than placebo and addressed a single serious adverse event of hyponatremia, citing confounding factors. A live webcast of the March 30 event will be available on the events and presentations section of the company’s website, with a replay available following completion of the event and archived for up to 30 days.