By Colin Kellaher


Shares of Neumora Therapeutics plunged on Monday after the U.S. Food and Drug Administration placed a clinical hold on an early study of a proposed treatment for schizophrenia following pre-clinical safety issues in animals.

Neumora shares, which closed Friday at $13.56, were recently down nearly 26% to $10.10 in premarket trading.

Neumora said it has paused its Phase 1 study of NMRA-266, in which about 30 participants have been dosed, after pre-clinical data showed convulsions in rabbits.

The Watertown, Mass., clinical-stage biopharmaceutical company said it hasn't seen any evidence of convulsions observed in any study participant, adding that it is working with the FDA to evaluate the potential to resolve the clinical hold, and that its prior guidance regarding the drug is no longer applicable.

Neumora last month had said it expected to report data from the Phase 1 study in mid-2024, and that it expected to initiate a Phase 1b study in schizophrenia in the second half of the year, with data from that study anticipated in 2025.


Write to Colin Kellaher at colin.kellaher@wsj.com


(END) Dow Jones Newswires

04-15-24 0720ET