Neumora’s Schizophrenia Drug Study Halted by FDA Due to Preclinical Safety Signals

1. The FDA has placed a clinical hold on Neumora Therapeutics' Phase I trial of its schizophrenia drug candidate NMRA-266 due to preclinical safety signals.
2. Preclinical data showed that NMRA-266, a highly selective positive allosteric modulator of the M4 muscarinic receptor, triggered convulsions in rabbits.
3. Around 30 patients have been enrolled and dosed in the Phase I ascending dose study, none of whom have shown signs of convulsions.
4. Neumora's shares dropped 26% in premarket trading following the news.
5. The company is working with the FDA to resolve the clinical hold and will provide an update on the development program once available.
6. Neumora's other pipeline assets, including navacaprant for major depressive disorder and NMRA-511 for Alzheimer's disease, will continue to be developed.
7. The clinical hold comes amid significant interest in muscarinic receptor-targeting drugs for psychotic conditions, with recent multibillion-dollar acquisitions in the field.
8. Neumora's prior guidance for NMRA-266 is no longer applicable due to the clinical hold.