Minerva Neurosciences Inc. shares declined 39% to $1.43 after the company said the U.S. Food and Drug Administration turned away a new-drug application for schizophrenia treatment roluperidone.
The clinical-stage biopharmaceutical company said it received a “refusal-to-file” letter from the FDA in October, and that following a Nov. 30 meeting, the agency has confirmed that the letter remains in effect for roluperidone as a treatment for negative symptoms in patients with schizophrenia.
Trading was halted at 9:32 a.m. EDT and resumed five minutes later. The stock is down 78% on the year.