Minerva Neurosciences Presents Data from its Open-label Safety Trial Evaluating 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

News Market Reaction – NERV

+0.66%

2 alerts

+0.66% News Effect

+3.4% Peak Tracked

+$2M Valuation Impact

$279.77M Market Cap

0.1x Rel. Volume

On the day this news was published, NERV gained 0.66%, reflecting a mild positive market reaction. Argus tracked a peak move of +3.4% during that session. Our momentum scanner triggered 2 alerts that day, indicating moderate trading interest and price volatility. This price movement added approximately $2M to the company's valuation, bringing the market cap to $279.77M at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

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

8 metrics

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)

Market Reality Check

Price: $6.18 Vol: Volume 433,888 is 1.02x t...

normal vol

$6.18 Last Close

Volume Volume 433,888 is 1.02x the 20-day average of 425,545, indicating only typical trading activity pre‑announcement. normal

Technical Shares traded above the 200-day MA of 3.58 at a pre‑news price of 6.08, despite being 51.2% below the 52-week high.

Peers on Argus

Among tracked biotech peers, movements were mixed: some down (e.g., one scanner ...

1 Down

Among tracked biotech peers, movements were mixed: some down (e.g., one scanner peer down 0.84%), others up, with no broad, same‑direction move matching NERV’s -7.79% pre‑news decline.

Historical Context

5 past events · Latest: Mar 12 (Neutral)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Mar 12	Conference participation	Neutral	+5.3%	Announcement of presentation at The Stifel 2026 Virtual CNS Forum.
Mar 11	Earnings and financing	Neutral	-8.1%	Q4/FY2025 results plus private placement and Phase 3 trial planning.
Mar 04	Conference participation	Neutral	-0.4%	Participation announcement for The Citizens Life Sciences Conference.
Jan 26	KOL event announcement	Neutral	+2.5%	Virtual KOL event to discuss roluperidone and Phase 3 trial design.
Nov 19	Board appointment & funding	Positive	+0.0%	New director plus private placement to fund Phase 3 and NDA plans.

Pattern Detected

Recent news and conference participation often produced modest price moves, while a major earnings/business update saw a larger negative reaction, suggesting sensitivity to financing and financial disclosures.

Recent Company History

Over the last few months, Minerva’s news flow has centered on roluperidone and investor outreach. Conference and event notices on Jan 26, 2026, Mar 4, 2026, and Mar 12, 2026 prompted small moves between about -0.44% and +5.34%. In contrast, the Mar 11, 2026 earnings and business update, including financing details and trial plans, coincided with a -8.06% reaction. Today’s safety/trial update fits the ongoing narrative of advancing roluperidone toward a confirmatory Phase 3 readout in 2H 2027.

Regulatory & Risk Context

Active S-3 Shelf · $200,000,000

Shelf Active

Active S-3 Shelf Registration 2026-03-11

$200,000,000 registered capacity

An effective S-3 shelf filed on 2026-03-11 registers up to $200,000,000 of securities, with 0 recorded usage so far. This framework enables future offerings of common stock, preferred stock, debt, or warrants via prospectus supplements.

Market Pulse Summary

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 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. Not financial advice.

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.