US FDA declines to approve Minerva Neurosciences’ schizophrenia drug

By Thomson Reuters Feb 27, 2024 | 7:13 AM

(Reuters) -Minerva Neurosciences said on Tuesday the U.S. Food and Drug Administration has declined to approve its drugto regulate behavioral changes in patients with schizophrenia that can cause social withdrawal and lack of motivation.

The company’s shares fell 64.9% to $2.33 in premarket trading.

Minerva said the FDA cited that data from the mid-to-late stage study of the drug roluperidone was not sufficient to establish substantial evidence of its effectiveness.

The health regulator’s decision marks another hurdle for the company, after the FDA denied to review its initial marketing application for the drug in 2022.

(Reporting by Pratik Jain, Puyaan Singh, Sriparna Roy and Sneha S K in Bengaluru; Editing by Shounak Dasgupta)