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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 it will host a virtual key opinion leader (KOL) event on Tuesday, February 3, 2026 at 10:30 AM ET featuring Gregory Strauss, PhD (Franklin Professor of Psychology, University of Georgia) and Brian Kirkpatrick, MD, MSPH (Peters Professor of Psychiatry, University of Arkansas for Medical Sciences). They will join the company management team to elaborate on the patient burden of the negative symptoms of schizophrenia, the challenges associated with assessing negative symptoms in the current regulatory environment and how the company's upcoming Phase 3 trial of roluperidone is expected to meet those challenges.
To register, click here.
Current antipsychotics do not adequately treat the negative symptoms of schizophrenia despite decades of clinical trials and myriad FDA approvals. Recognizing there has never been a drug approved specifically for negative symptoms, FDA hosted a public meeting in August 2024 to establish the optimal approach in clinical trials. Minerva plans to start a confirmatory Phase 3 trial in 2026 utilizing a novel protocol, which is aligned with FDA considerations and designed to maximize the probability of a successful outcome.
A live question and answer session will follow the formal presentations.
About Gregory Strauss, PhD
Gregory Strauss, PhD, is the Franklin Professor of Psychology and Neuroscience at the University of Georgia where he directs the Clinical Affective Neuroscience Laboratory and Georgia Psychiatric Risk Evaluation Program. His research primarily examines the phenomenology, etiology, assessment, and treatment of negative symptoms in individuals diagnosed with schizophrenia and youth at clinical high-risk for psychosis. He has published over 275 widely cited papers. His research has been recognized with several awards (e.g., rising star award from the Schizophrenia International Research Society (SIRS), early career award from the National Academy of Neuropsychology (NAN), Wechsler early career award from the American Psychological Foundation) and supported by more than $82 million in grants from federal and private organizations such as the National Institutes for Health (NIH), National Science Foundation (NSF), Brain & Behavior Research Foundation, and VA Mental Illness Research and Treatment Psychology Fellowship Program (MIRECC).
About Brian W. Kirkpatrick, MD, MSPH
Brian W. Kirkpatrick, MD, MSPH, is a Peters Professor in the Department of Psychiatry at the University of Arkansas for Medical Sciences. Dr. Kirkpatrick is a nationally and internationally renowned expert on schizophrenia and related disorders, whose pioneering research has advanced many life-changing treatments. He graduated from the University of Texas Medical School at Houston. At the University of North Carolina Chapel Hill, he completed a psychiatry residency, the Robert Wood Johnson Clinical Scholar Program, a Master of Science in Public Health in epidemiology, and a fellowship in neuropharmacology. Dr. Kirkpatrick has focused on schizophrenia and related disorders. He co-chaired the National Institute of Mental Health (NIMH)-sponsored Consensus Development Conference on Negative Symptoms. He has been funded by NIMH, the National Institute of Diabetes and Digestive and Kidney Diseases, the Brain and Behavior Research Foundation, and the Scottish Rite Foundation. He was associate editor of Clinical Schizophrenia and Related Psychoses and has served on the editorial board of Schizophrenia Bulletin. He joined the University of Arkansas for Medical Sciences (UAMS) Department of Psychiatry in 2022 and in 2024 was awarded the John Emmett Peters Endowed Chair in Psychiatry.
About Negative Symptoms of Schizophrenia
Schizophrenia is a complex and disabling psychiatric disorder that affects millions of adults worldwide imposing a substantial health, social, and economic burden. Symptoms of schizophrenia are described in terms of positive, negative and cognitive symptoms.
Negative symptoms are extremely debilitating and ultimately prevent people from being able to live independently. Negative symptoms include blunted affect, alogia, avolition, anhedonia, and asociality. People suffering with impairing negative symptoms often require comprehensive care from healthcare systems and families and experience a reduced quality of life including significantly greater conceptual disorganization and psychosis, increased likelihood of hospitalization, poorer social functioning, pronounced social cognitive impairment, increased likelihood of unemployment or low-quality employment.
Approximately 50% to 60% of people living with schizophrenia experience at least one primary/disease related negative symptom. Although antipsychotics have been shown to reduce positive symptoms (i.e., delusions and hallucinations) and can reduce secondary negative symptoms (i.e., the negative symptoms associated with psychosis, delusions and treatment with antipsychotics) the primary negative symptoms (i.e., fundamental to the disease) do not respond to antipsychotics. While several antipsychotics are approved by the FDA for the treatment of schizophrenia, none are specifically approved to treat negative symptoms, which the FDA has acknowledged is currently an unmet medical need.
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, 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; 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; 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, 2024, filed with the Securities and Exchange Commission on February 25, 2025, as updated by its Quarterly Report on Form 10-Q for the quarter ended September 30, 2025. 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
