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Minerva Neurosciences (NASDAQ: NERV) lost about 60% on Tuesday, after announcing that the U.S. Food and Drug Administration (FDA) rejected its lead product candidate, roluperidone, aimed at negative symptoms associated with schizophrenia.
In a so-called full response letter issued in connection with NERV’s New Drug Application (NDA), the FDA argued that the company’s successful MIN-101C03 study for roluperidone was “in itself insufficient to establish substantial evidence of efficacy.”
The agency requested data from at least one other study to support its safety and effectiveness.
“We will review the FDA’s feedback and consider our potential paths forward, including continuing to work closely with the FDA and providing any additional information needed, with the goal of bringing this much-needed therapy to patients and physicians,” he said. said CEO Remy Luthringer.
ACADIA Pharmaceuticals (ACAD), another developer of schizophrenia drugs, rose following the announcement. NERV’s other potential competitors include Karuna Therapeutics (KRTX), whose schizophrenia therapy KarXT is currently under review by the FDA.
In December, Bristol-Myers Squibb (BMY) agreed to acquire Karuna Therapeutics (KRTX) for $14 billion in cash in a deal expected to close early this year.