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Minerva Neurosciences Establishes Scientific Advisory Board to Advance Development of Roluperidone and Future Pipeline Programs

  • Minerva Neurosciences formed a Scientific Advisory Board (SAB) on June 1, 2026, fulfilling a commitment from its October 21, 2025 PIPE financing.
  • The SAB includes eight members: Michael Davidson, Philip Harvey, Oliver Howes, Inder Kaul, Brian Kirkpatrick, Remy Luthringer, Avi Reichenberg, & Greg Strauss.
  • The board will advise on the Phase 3 confirmatory trial (NCT07565428; MIN-101C19) of roluperidone for negative symptoms of schizophrenia & the company's broader psychiatric pipeline.
  • Roluperidone is an investigational monotherapy designed to avoid direct dopamine receptor blockade while targeting 5-HT2A, sigma2, & adrenergic-α1A receptors.
  • The Phase 3 trial will enroll approximately 380 adults aged 18–55 with moderate to severe negative symptoms & stable positive symptoms.
  • The trial utilizes a two-part design: Phase A is a 12-week placebo-controlled study evaluating the Marder Negative Symptoms Factor Score, with topline data expected in the second half of 2027.
  • Phase B extends the study for 52 weeks using an active-controlled design to compare relapse rates against risperidone, aripiprazole, or olanzapine.
  • The company highlights that no FDA-approved monotherapy currently exists for the negative symptoms of schizophrenia, which include avolition, anhedonia, & social withdrawal.
  • Minerva Neurosciences notes that prior pivotal trials demonstrated significant improvements in negative symptoms, establishing roluperidone as the only monotherapy to date with such results.