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

Minerva Neurosciences (Nasdaq: NERV) presented results from an open‑label safety trial of roluperidone co‑administered with olanzapine at SIRS 2026.

Rhea-AI Summary

Minerva Neurosciences (Nasdaq: NERV) presented results from an open‑label safety trial of roluperidone co‑administered with olanzapine at SIRS 2026.

The trial reported no clinically significant adverse effects, no meaningful pharmacokinetic changes, and no pharmacodynamic changes during combined administration. A confirmatory Phase 3 is enrolling with topline data anticipated in H2 2027.

Positive

• No clinically significant adverse effects observed during co‑administration
• No meaningful pharmacokinetic (PK) changes detected with olanzapine
• No pharmacodynamic (PD) changes observed during combined administration
• Confirmatory Phase 3 trial now enrolling with topline data expected in H2 2027

Negative

• Open‑label safety trial did not report efficacy or symptom‑improvement readouts
• Topline Phase 3 results not expected until H2 2027, delaying definitive clinical assessment

Argus Mar 26 session

+0.66% close to close Open Argus

Details

News Market Reaction – NERV

In the Mar 26 session, NERV gained 0.66%, reflecting a mild positive market reaction.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement highlighted open-label safety data showing no clinically significant adverse effec...

Analysis

This announcement highlighted open-label safety data showing no clinically significant adverse effects or meaningful PK/PD changes when roluperidone is co‑administered with olanzapine, supporting its use alongside a widely used antipsychotic. It fits into Minerva’s broader plan for a 380-patient confirmatory Phase 3 trial with a 12-week primary endpoint and relapse data expected in 2H 2028. Investors may weigh this against the company’s $293.4 million 2025 net loss, $688.8 million accumulated deficit, and an effective $200,000,000 S-3 shelf.

Key Figures

Shelf registration size: $200,000,000 Phase 3 sample size: 380 patients Primary endpoint duration: 12 weeks +5 more

Shelf registration size

$200,000,000

S-3 shelf filed 2026-03-11

Phase 3 sample size

380 patients

Planned confirmatory Phase 3 C19 trial

Primary endpoint duration

12 weeks

Phase 3 C19 primary endpoint period

Relapse assessment phase

40 weeks

Phase 3 C19 relapse-assessment phase

2025 net loss

$293.4 million

GAAP net loss for 2025 (10-K and 8-K)

Accumulated deficit

$688.8 million

As of December 31, 2025

Cash position

$82.4 million

Cash, cash equivalents and restricted cash at 12/31/2025

Shares outstanding

43,274,398 shares

As of February 28, 2026 (S-3 summary)

Historical Context

5 past events · Latest: Mar 12

5 events

1. Mar 12

   Conference participation

   24h Move

   +5.3%

   Announcement of presentation at The Stifel 2026 Virtual CNS Forum.

2. Mar 11

   Earnings and financing

   24h Move

   -8.1%

   Q4/FY2025 results plus private placement and Phase 3 trial planning.

3. Mar 04

   Conference participation

   24h Move

   -0.4%

   Participation announcement for The Citizens Life Sciences Conference.

4. Jan 26

   KOL event announcement

   24h Move

   +2.5%

   Virtual KOL event to discuss roluperidone and Phase 3 trial design.

5. Nov 19

   Board appointment & funding

   24h Move

   +0.0%

   New director plus private placement to fund Phase 3 and NDA plans.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

open-label, pharmacokinetic, pharmacodynamic, antipsychotic, +1 more

5 terms

open-label medical

"The presentation titled “A Study of Roluperidone Coadministered with Olanzapine...: A Safety Open-Label Trial”"

Open-label describes a situation where everyone involved in a study or process knows the full details, such as who is receiving a treatment or intervention. For investors, understanding whether a project or product is open-label helps gauge the level of transparency and potential biases, influencing trust and decision-making. It’s like knowing whether a test or experiment is conducted openly or behind closed doors.

pharmacokinetic medical

"...highlights safety, pharmacokinetic (PK), and pharmacodynamic (PD) findings from the trial."

Pharmacokinetic describes how a drug moves through and leaves the body — how it is absorbed, spread to tissues, broken down and excreted — like tracking a package from pickup to delivery and disposal. For investors, these properties determine effective dose, safety risks, how often a medicine must be taken, and how reliably it works, which in turn influence clinical trial success, regulatory approval chances, production complexity and a drug’s commercial value.

pharmacodynamic medical

"...highlights safety, pharmacokinetic (PK), and pharmacodynamic (PD) findings from the trial."

Pharmacodynamic describes how a drug acts on the body — the biological effects it produces, how strong those effects are, and how long they last. For investors, pharmacodynamic data show whether a treatment actually works and at what dose, shaping expectations about a drug’s safety, effectiveness, regulatory success and market potential; think of it like testing how well a key turns a lock and whether it reliably opens the door.

antipsychotic medical

"The trial was designed to assess potential interactions between roluperidone and a widely used antipsychotic, olanzapine."

A medication class used to treat psychosis and severe mood or behavioral disturbances by rebalancing brain signaling; think of them as tools that calm overactive brain circuits much like a dimmer reduces an overly bright light. They matter to investors because approval, safety profile, patent status, and insurance coverage directly affect sales, market size, development costs and regulatory risk for companies that make or market these drugs.

negative symptoms of schizophrenia medical

"A Study of Roluperidone Coadministered with Olanzapine in Patients with Negative Symptoms of Schizophrenia"

Persistent reductions in normal behavior and emotion such as diminished motivation, blunted facial expression, social withdrawal, and reduced speech — imagine a phone battery that won’t hold a charge, leaving someone less able or willing to engage. For investors, these symptoms are a central target for new psychiatric drugs and therapies because they drive long-term disability, shape clinical trial outcomes and regulatory approval decisions, and determine potential market need and size.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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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

• Title: Olanzapine Added to Roluperidone, in Patients With Schizophrenia and Moderate to Severe Negative Symptoms: A Safety Open-Label Trial
• Presenter / Co-Author: Michael Davidson, MD
• Session: Pharmaceutical Pipeline
• Session Chair: Dr. Mark Weiser
• Date: Thursday, March 26, 2026
• Session Time: 10:30 AM – 12:00 PM
• Location: Room Verde
• Presentation Time: 11:42 AM – 12:00 PM (CET)
  
  

The presentation will be made available following the conference on Minerva’s website under the Presentations section at: https://tinyurl.com/MinervaPresentations.

About Minerva Neurosciences
Minerva 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’s website.

Contacts:

Investor inquiries:

Frederick Ahlholm
Chief Financial Officer
Minerva Neurosciences, Inc.
info@minervaneurosciences.com

Corey Davis, Ph.D.
LifeSci Advisors, LLC
212-915-2577
cdavis@lifesciadvisors.com

FAQ

What did Minerva (NERV) report about roluperidone co‑administered with olanzapine at SIRS 2026?

The trial showed no clinically significant adverse effects and no meaningful PK/PD changes. According to Minerva, the open‑label safety study found no safety or interaction concerns during combined administration.

When and where did Minerva present the roluperidone plus olanzapine safety data (NERV)?

Minerva presented the data at SIRS 2026 in Florence, Italy on March 25–29, 2026. According to Minerva, the specific presentation occurred March 26 during the Pharmaceutical Pipeline session at 11:42 AM CET.

Does the SIRS 2026 presentation change the roluperidone development timeline for Minerva (NERV)?

The company continues to advance the program and the Phase 3 trial is enrolling. According to Minerva, topline Phase 3 data are anticipated in the second half of 2027.

Will the SIRS 2026 safety trial data include efficacy results for roluperidone (NERV)?

No, the open‑label safety trial reported safety, PK, and PD findings but did not present efficacy endpoints. According to Minerva, the study focused on interaction and tolerability rather than efficacy outcomes.

Where can investors access the Minerva (NERV) SIRS 2026 presentation and slides?

The presentation will be posted on Minerva’s website under Presentations after the conference. According to Minerva, materials will be available via the Presentations section at the company website link provided.