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Minerva Neurosciences Presents Data from its Open-label Safety Trial Evaluating Roluperidone Co-administered with Olanzapine at SIRS 2026

Key Takeaway: Minerva Neurosciences presented positive data from its open-label safety trial of roluperidone co-administered with olanzapine at the SIRS 2026 conference. The trial showed no significant safety concerns or adverse effects, supporting the ongoing Phase 3 trial, which is currently enrolling participants. Topline results are anticipated in late 2027.
Price reaction · baseline $6.1 (2026-03-25 close) · hit pre-market · clean, no other NERV news in the window
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POSITIVE FACTORS

  • No safety concerns were identified during the trial.
  • The Phase 3 trial is now enrolling participants.
  • Topline data is expected in the second half of 2027.

BiopharmaWatch Analysis

From our catalyst data and publicly available data · not financial advice
Best trade, last catalyst
+355%
120-day peak, hindsight
Typical move
29.3%
average across 2 past catalysts
Cash runway
~16 mo
Low dilution risk
Lead asset
MIN-117
Phase 2 · Major Depressive Disorder

Full Press Release Details

Trial demonstrated no safety concerns when co-administering roluperidone and olanzapine
The Company continues to advance the program, with the confirmatory Phase 3 trial now enrolling and topline data anticipated in the second half of 2027
BURLINGTON, Mass., March 25, 2026(GLOBE NEWSWIRE)-- Minerva Neurosciences, Inc. (Nasdaq: NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system disorders, today announced the presentation of clinical data from its open‑label safety trial evaluating roluperidone co‑administered with olanzapine at the 2026 Schizophrenia International Research Society (SIRS) Annual Congress, held March 25–29, 2026, at Firenze Fiera in Florence, Italy.
The presentation titled “A Study of Roluperidone Coadministered with Olanzapine in Patients with Negative Symptoms of Schizophrenia” is being delivered by Michael Davidson, MD, Chief Medical Officer of Minerva Neurosciences and highlights safety, pharmacokinetic (PK), and pharmacodynamic (PD) findings from the trial. The trial was designed to assess potential interactions between roluperidone and a widely used antipsychotic, olanzapine. The trial shows no clinically significant adverse effects, no meaningful pharmacokinetic (PK) changes, and no pharmacodynamic (PD) changes during combined administration.

Presentation Details

The presentation will be made available following the conference on Minerva’s website under the Presentations section at:https://tinyurl.com/MinervaPresentations.
About Minerva NeurosciencesMinerva Neurosciences, Inc. is a clinical-stage biopharmaceutical company focused on developing product candidates to treat CNS diseases. Minerva’s goal is to transform the lives of patients with improved therapeutic options, including roluperidone for negative symptoms of schizophrenia. For more information, please visit the Company’swebsite.

Frederick AhlholmChief Financial OfficerMinerva Neurosciences, Inc.info@minervaneurosciences.com

Corey Davis, Ph.D.LifeSci Advisors, LLC212-915-2577cdavis@lifesciadvisors.com

Frequently Asked Questions

What were the findings of the safety trial?

The trial found no safety concerns or significant adverse effects when roluperidone was co-administered with olanzapine.

When is the topline data expected?

Topline data from the ongoing Phase 3 trial is anticipated in the second half of 2027.

Where was the data presented?

The data was presented at the 2026 Schizophrenia International Research Society Annual Congress in Florence, Italy.

Who presented the trial data?

The presentation was delivered by Michael Davidson, MD, Chief Medical Officer of Minerva Neurosciences.

Last updated: Mar 26, 2026