Neumora Therapeutics (NMRA) said Monday a repeat safety study of its experimental oral obesity drug, NMRA-215, found no unexpected in-life adverse findings, supporting plans to file an investigational new drug application in the fourth quarter of 2026.
The company said it repeated the 13-week rat study after an earlier study reported unexpected findings in five of 142 animals.
Neumora said an audit found discrepancies that resulted in critical audit observations in how the earlier study was conducted, and the new results, along with previous studies in rats and dogs, suggest the earlier findings were not caused by NMRA-215.
Neumora said its preclinical studies showed NMRA-215 produced weight loss as a monotherapy, increased weight loss when used with semaglutide, and improved markers linked to heart and metabolic health.
It added that it expects to begin a Phase 1 clinical trial by the end of 2026.