“Minerva will initiate a confirmatory phase 3 study in Q2 of 2026 which will evaluate treatment compared to placebo at 12 weeks as measured by Marder Negative Symptom Factor Score as the primary endpoint. If successful, this study will be part of the resubmission of an NDA to the FDA seeking approval for what would be the first FDA-approved therapy specifically indicated for the treatment of negative symptoms of schizophrenia.”
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I wonder how they will position it against other upcoming drugs if they find it effective in it’s intended target.
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The FDA had already rejected roluperidone twice. They gave the company one last chance, requesting more specific and rigorous testing. If approved, it would be the first drug therapy for negative symptoms. I agree with your question; we’ll have to see what communication strategy the laboratory adopts, which, from what I understand, is not a large laboratory.
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