FDA Places Hold on Neumora Schizophrenia Study

The FDA has placed a clinical hold on Neumora Therapeutics’ (Nasdaq: NMRA) Phase 1 trial of NMRA-266 after the compound resulted in convulsions in rabbits in the company’s preclinical studies. The company’s stock tumbled 17.5% to close at $11.19 after the announcement last week. The stock closed down an additional 3.51% on Friday and has continued its decline, dropping a further 1.87% in morning trading on Monday. Neumora has a market cap of $1.61 billion.

Neumora has placed its study on pause, but noted that the 30 human participants that have been dosed in the company’s Phase 1 study have shown no evidence of convulsions.

Commenting on the news, Henry Gosebruch, president and chief executive officer, Neumora, said, “We are disappointed with the unanticipated safety findings in rabbits and are discussing next steps with the FDA. In parallel, we’re continuing to make significant progress across the rest of our portfolio as we seek to fulfill our mission to develop medicines for serious brain diseases.”

Neumora is working with the FDA to evaluate the potential to resolve the clinical hold and will provide an update on NMRA-266 when available.

About Neumora
Neumora Therapeutics, Inc. is a clinical-stage biopharmaceutical company founded to confront the global brain disease crisis by taking a fundamentally different approach to the way treatments for brain diseases are developed. Our therapeutic pipeline currently consists of seven clinical and preclinical neuroscience programs that target novel mechanisms of action for a broad range of underserved neuropsychiatric disorders and neurodegenerative diseases. Our work is supported by an integrated suite of translational, clinical, and computational tools to generate insights that can enable precision medicine approaches. Neumora’s mission is to redefine neuroscience drug development by bringing forward the next generation of novel therapies that offer improved treatment outcomes and quality of life for patients suffering from brain diseases.

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FDA Places Hold on Neumora Schizophrenia Study

Catie Corcoran

Biotech Editor