Minerva Neurosciences ($NERV) is a clinical-stage biotech with a tight focus on CNS disorders, led by roluperidone for the negative symptoms of schizophrenia—an area with major unmet need and first-in-class potential. In this episode, we unpack its single-asset concentration, mixed study history and regulatory pushback, and a lean, partner-friendly model that could support a focused U.S. launch while outsourcing ex-U.S. markets. The opportunity is meaningful—improving motivation and social functioning could be a true differentiator—but the path is binary: FDA evidence demands, payer scrutiny, competition from entrenched antipsychotics, and ongoing financing/dilution risks loom large. Watch the cash runway and SEC filings, FDA meeting outcomes and clinical plan updates, and any partnership or non-dilutive funding. Can NERV turn regulatory alignment into approval and carve a durable niche in schizophrenia care, or will another study, slow adoption, and capital constraints stall the story?
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