Preclinical Safety Signal Prompts FDA Clinical Hold on Neumora Schizophrenia Drug

Neumora Therapeutics’ drug NMRA-266, targeting schizophrenia, has been placed on FDA clinical hold after rabbits showed convulsions in preclinical testing. The Phase 1 study has dosed 30 participants with no adverse effects. Neumora is working with the FDA to resolve the hold, while also developing other M4-targeting molecules. Delays in resolving the hold could extend up to a year. Despite setbacks, investors are focused on the lead program navacaprant for major depressive disorder. Neumora went public in September 2021, raising $250 million. Shares fell 18.3% after the clinical hold announcement. Neumora remains hopeful for the future of its drug development programs.

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