US FDA declines to approve Minerva Neurosciences' schizophrenia drug (updated)

Minerva Neurosciences

27/02/2024 13:48

(Adds shares in paragraph 2 and details on FDA decision in
paragraph 3)
       Feb 27 (Reuters) - Minerva Neurosciences  NERV.O  said
on Tuesday the U.S. Food and Drug Administration has declined to
approve its drug
to 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)
 ((Pratik.Jain@thomsonreuters.com))