Minerva Neurosciences Announces First Patient Screened in Global Phase 3 Confirmatory Trial of Roluperidone for the Treatment of Negative Symptoms of Schizophrenia

Rhea-AI Summary

Minerva Neurosciences (Nasdaq: NERV) screened the first patient in its global confirmatory Phase 3 trial of roluperidone for negative symptoms of schizophrenia on March 31, 2026. The trial will enroll ~380 patients across ~40 sites including the US and Europe.

The study follows prior pivotal Phase 2b and Phase 3 trials that showed consistent improvements at the 64 mg dose. Efficacy topline data are expected in 2H 2027, and the design reflects prior FDA discussions.

Positive

• First patient screened in confirmatory Phase 3 (March 31, 2026)
• ~380 patients to be enrolled across roughly 40 sites worldwide
• Prior pivotal C03 and C07 trials showed consistent improvements at 64 mg
• Topline efficacy data expected in 2H 2027

Negative

• No FDA-approved treatments currently exist for negative symptoms
• Regulatory approval depends on successful Phase 3 results expected in 2H 2027
• Clinical and commercialization outcomes remain uncertain until pivotal readout

Key Figures

Planned enrollment: 380 patients Clinical sites: roughly 40 sites Dose level: 64 mg +1 more

4 metrics

Planned enrollment 380 patients Global confirmatory Phase 3 trial of roluperidone

Clinical sites roughly 40 sites Phase 3 trial across US and multiple European countries

Dose level 64 mg Dose that showed consistent improvement in prior C03 and C07 trials

Topline efficacy timing 2H 2027 Expected timing for Phase 3 roluperidone efficacy topline data

Market Reality Check

Price: $6.03 Vol: Volume 148,826 is 0.33x t...

low vol

$6.03 Last Close

Volume Volume 148,826 is 0.33x the 20-day average of 447,988, indicating muted pre-news participation. low

Technical Shares traded above the 200-day MA of 3.67 with a pre-news price of 5.97, despite a -3.4% daily move.

Peers on Argus

Pre-news scanner data flagged the target as moving up, while peers showed mixed ...

1 Up 1 Down

Pre-news scanner data flagged the target as moving up, while peers showed mixed moves (e.g., BIVI down and APLM up). Sector peers in the broader list also show both gains and losses, pointing to stock-specific drivers rather than a unified biotech move.

Previous Clinical trial Reports

1 past event · Latest: Oct 21 (Positive)

Same Type Pattern 1 events

Date	Event	Sentiment	Move	Catalyst
Oct 21	Clinical financing update	Positive	+141.0%	Financing of up to $200M to fund confirmatory Phase 3 and NDA work.

Pattern Detected

For similar clinical-trial-related financing news, the stock previously reacted very strongly to the upside, but the current confirmatory Phase 3 milestone came against a weaker price backdrop.

Recent Company History

Over the past months, Minerva has consistently highlighted roluperidone’s path toward a confirmatory Phase 3 program. In Oct 2025, a financing of up to $200 million to fund the Phase 3 trial and NDA resubmission drove a +140.98% move. Subsequent 2026 updates reiterated plans for a ~380-patient Phase 3 with topline data in 2H 2027, setting the stage for today’s first-patient-screened announcement.

Historical Comparison

+141.0% avg move · For clinical-trial-related news, NERV’s single prior same-tag event moved +140.98%. Today’s -3.4% pr...

clinical trial

+141.0%

Average Historical Move clinical trial

For clinical-trial-related news, NERV’s single prior same-tag event moved +140.98%. Today’s -3.4% pre-news move contrasts with that historically strong upside reaction.

The company has progressed from securing up to $200M to fund a confirmatory Phase 3 to now screening the first patient in that global trial.

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 allows Minerva to issue up to $200,000,000 of various securities, with 0 usage recorded so far. Specific offering terms would be detailed in future prospectus supplements.

Market Pulse Summary

This announcement marks operational execution as Minerva screens the first patient in its global con...

Analysis

This announcement marks operational execution as Minerva screens the first patient in its global confirmatory Phase 3 trial of roluperidone, targeting negative symptoms of schizophrenia with no current FDA-approved treatments. The design builds on prior positive C03 and C07 data and aims for efficacy topline in 2H 2027. Investors may watch enrollment across ~380 patients, future regulatory updates, and any use of the $200,000,000 shelf for funding.

Key Terms

phase 3, monotherapy, negative symptoms, anhedonia, +2 more

6 terms

phase 3 medical

"first patient has been screened in its global, confirmatory Phase 3 clinical trial"

Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.

monotherapy medical

"Phase 3 clinical trial evaluating roluperidone as monotherapy for the treatment"

Monotherapy is a treatment approach that uses only one type of medicine or therapy to address a condition, instead of combining multiple options. For investors, understanding monotherapy matters because it can influence a company's development strategy, risk profile, and potential market size, especially if the single-treatment approach proves effective or faces limitations compared to combination therapies.

negative symptoms medical

"monotherapy for the treatment of negative symptoms of schizophrenia"

Negative symptoms are reductions or losses in normal behaviors and emotions—such as lack of motivation, flattened facial expression, social withdrawal, and reduced speech—commonly seen in psychiatric conditions. For investors, they matter because these symptoms are hard to treat, drive development of therapies, shape clinical trial goals and regulatory decisions, and therefore influence the potential market size and valuation of companies working on effective treatments.

anhedonia medical

"including avolition (severe lack of motivation), anhedonia (inability to experience pleasure)"

Anhedonia is the reduced ability to feel pleasure or interest in things that used to be enjoyable, like hobbies, socializing, or eating; think of it as a dimmer switch turning down the joy in everyday activities. For investors, it matters because anhedonia is a common symptom targeted by drugs, therapies, and diagnostics, so its prevalence and how well treatments address it can affect clinical trial outcomes, regulatory approval prospects, market demand, and a healthcare company's valuation.

clinical trial medical

"global, confirmatory Phase 3 clinical trial evaluating roluperidone"

A clinical trial is a carefully controlled study in which a new medicine, medical device, or treatment is tested on people to see if it is safe and effective. For investors it matters because trial results determine whether a product can win regulatory approval and reach patients, much like a road test decides if a new car can be sold; positive or negative results can sharply change a company’s prospects and stock value.

fda regulatory

"follows productive discussions with the FDA on the overall design"

The FDA is the U.S. federal agency that evaluates and approves medical drugs, devices, biological therapies and certain foods; think of it as the gatekeeper that decides whether a medical product is safe and effective for patients. For investors, FDA decisions determine whether a company can sell a product, affect expected revenue and introduce regulatory risk, so approvals, rejections or safety warnings can quickly move a company's valuation and stock price.

AI-generated analysis. Not financial advice.

Roluperidone has been de-risked by consistent positive results in two prior pivotal trials and remains the only late-stage drug candidate for this high-need population

Efficacy topline data expected 2H 2027

BURLINGTON, Mass., March 31, 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 that the first patient has been screened in its global, confirmatory Phase 3 clinical trial evaluating roluperidone as monotherapy for the treatment of negative symptoms of schizophrenia. Negative symptoms, including avolition (severe lack of motivation), anhedonia (inability to experience pleasure) and social withdrawal can lead to profound personal and functional impairment and represent one of the greatest unmet needs in schizophrenia. There are currently no FDA-approved treatments with this indication.

The Phase 3 trial will enroll approximately 380 patients across roughly 40 clinical sites worldwide, including the United States (US) and multiple European countries. This confirmatory Phase 3 trial follows productive discussions with the FDA on the overall design and efficacy assessments. It builds directly on Minerva’s clinical success in the prior pivotal Phase 2b and Phase 3 trials (C03 and C07), both of which demonstrated consistent improvements in negative symptoms with the 64 mg dose of roluperidone.

“Initiation of this confirmatory Phase 3 trial is an important milestone for Minerva and for patients living with persistent and impairing negative symptoms of schizophrenia,” said Dr. Remy Luthringer, Executive Chairman and CEO of Minerva Neurosciences. “With no approved treatments for this indication in the US, roluperidone remains the only late-stage candidate in development for this population. The study builds directly on our prior experience showing consistent results across the two earlier trials and our execution strategy gives us confidence in our timelines.”

“Patients with schizophrenia often live with persistent negative symptoms such as avolition and anhedonia - challenges that remain even when positive symptoms are controlled with current therapies,” said Dr. Elan Cohen, Principal Investigator at CenExel Marlton, New Jersey and Lead Coordinating Investigator for the trial. “By evaluating roluperidone in a population with stable positive symptoms, this trial isolates its potential to improve these core drivers of disability while laying the groundwork for a broader treatment strategy. Strengthening motivation, cognition, and functioning may ultimately support more comprehensive symptom control over time, and the consistency seen in prior studies makes this confirmatory Phase 3 trial especially compelling.”

About the Phase 3 MIN-101C19 Trial
The global Phase 3 MIN-101C19 trial will enroll approximately 380 adults aged 18–55 with moderate to severe negative symptoms of schizophrenia, confirmed by a Positive and Negative Syndrome Scale (PANSS) negative subscale score greater than 20 and stable positive symptoms for at least six months. The trial utilizes a two-part design. The overall objective of the study is to confirm the effect of roluperidone on primary negative symptoms at 12 weeks compared to placebo and to evaluate longer-term relapse of positive symptoms compared with commonly prescribed antipsychotic medications for an additional 40 weeks.

The trial is designed to minimize variability and maximize sensitivity to treatment effect, including standardized assessments, and comprehensive caregiver engagement. Topline data from the 12-week Phase A portion (i.e., primary efficacy endpoint) of the trial are expected in the second half of 2027. The trial’s operational model includes intensive rater training, real-time monitoring of scoring data, and structured caregiver outreach to support safety tracking, functional assessments, and adherence.

Phase A is a12-week, randomized, double-blind, placebo-controlled phase during which patients will receive 64 mg of roluperidone or placebo to evaluate the primary endpoint: change from baseline in the Marder Negative Symptoms Factor Score (NSFS), which is a factor-analytic composite created from selected PANSS items. The sole key secondary endpoint is the change from baseline in the Personal and Social Performance (PSP) total score. Other secondary endpoints include a broad set of additional clinical measures, including PANSS subscales, Clinical Global Impression – Severity (CGI-S), Clinical Global Impression – Improvement (CGI-I), the Calgary Depression Scale, avolition-specific analyses, and patient and caregiver treatment-satisfaction ratings.

Phase B extends the trial for 40 weeks using a double-dummy, active-controlled, randomized design comparing continued roluperidone with three commonly prescribed antipsychotic medications (risperidone, aripiprazole, or olanzapine). This phase is designed to compare relapse rates between treatment groups. Relapses of positive symptoms will be evaluated using a rigorous, multi-component definition incorporating psychometric endpoints based on PANSS score worsening, and clinically meaningful events such as hospitalization or dangerous behavior.

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.

Forward-Looking Safe Harbor Statement
This press release contains forward-looking statements which are subject to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts, reflect management’s expectations as of the date of this press release, and involve certain risks and uncertainties. Forward-looking statements include, but are not limited to, statements herein with respect to implied or express statements regarding the anticipated clinical benefits and market opportunities associated with roluperidone, including its potential to address clinical and regulatory challenges; and the expected timeline, design, and conduct of Minerva’s Phase 3 trial of roluperidone. These forward-looking statements are based on our current expectations and may differ materially from actual results due to a variety of factors including, without limitation, trials and studies may be delayed and may not have satisfactory outcomes, and earlier trials and studies may not be predictive of later trials and studies; the design and rate of enrollment for clinical trials, including the current design of the confirmatory Phase 3 trial evaluating roluperidone may not enable successful completion of the trial(s); the commercial opportunity for roluperidone in negative symptoms of Schizophrenia may be smaller than anticipated; Minerva may be unable to obtain and maintain regulatory approvals; Minerva may experience uncertainties inherent in the initiation and completion of clinical trials and clinical development; Minerva’s future financial performance and position may not improve, resulting in difficulties in implementing Minerva’s business strategy, and plans and objectives for future operations; the expected sufficiency of Minerva’s existing cash resources and runway may not be accurate resulting in the need for additional financing sooner than anticipated or unexpected liquidity constraints; the internal and external costs required for Minerva’s ongoing and planned activities, and the resulting impact on expense and use of cash, may be higher than expected, which may cause the company to use cash more quickly than expected or to change or curtail some of Minerva’s plans or both; the need to align with collaborators or partners may hamper or delay development and regulatory efforts or increase costs; uncertainties of patent protection and litigation; general economic conditions; and other factors that are described under the caption “Risk Factors” in Minerva’s filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the year ended December 31, 2025, filed with the Securities and Exchange Commission. Copies of reports filed with the SEC are posted on Minerva’s website at http://ir.minervaneurosciences.com/. The forward-looking statements in this press release are based on information available to the Company as of the date hereof, and the Company disclaims any obligation to update any forward-looking statements, except as required by law.

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 milestone did Minerva Neurosciences (NERV) announce on March 31, 2026?

They screened the first patient in a global confirmatory Phase 3 trial for roluperidone on March 31, 2026. According to the company, the trial will enroll ~380 patients across roughly 40 sites including the US and Europe.

How many patients and sites will the NERV Phase 3 roluperidone trial include?

The trial will enroll approximately 380 patients across about 40 clinical sites worldwide. According to the company, sites include locations in the US and multiple European countries to support global enrollment.

When does Minerva expect topline efficacy results for roluperidone (NERV)?

Topline efficacy data are expected in 2H 2027. According to the company, this timeline follows initiation of the confirmatory Phase 3 and builds on prior pivotal trial experience.

What prior clinical evidence supports Minerva's Phase 3 roluperidone study (NERV)?

Two prior pivotal trials (C03 and C07) demonstrated consistent improvements in negative symptoms at the 64 mg dose. According to the company, these results informed the confirmatory Phase 3 design and endpoints.

What patient population is Minerva targeting in the NERV Phase 3 trial?

The trial targets patients with schizophrenia who have persistent negative symptoms and stable positive symptoms. According to the company, this isolates roluperidone's potential to improve motivation, pleasure, and social functioning.

Does roluperidone have any approved indication for negative symptoms in the US?

No, there are currently no FDA-approved treatments for negative symptoms of schizophrenia in the US. According to the company, the confirmatory Phase 3 is intended to support potential approval if results are positive.