Minerva Neurosciences Announces Update on its New Drug Application (NDA) for Roluperidone for the Treatment of Negative Symptoms in Schizophrenia
May 10 2023 - 8:00AM
Minerva Neurosciences, Inc. (Nasdaq: NERV), a clinical-stage
biopharmaceutical company focused on the development of therapies
to treat central nervous system (CNS) disorders, today announced
that on May 8, 2023, it received confirmation from the U.S. Food
and Drug Administration (FDA) that the Company’s New Drug
Application (NDA) for roluperidone for the treatment of negative
symptoms in patients with schizophrenia has been filed in
accordance with the recent Appeal Granted letter dated April 27,
2023 and assigned a standard review classification. The FDA has
assigned a Prescription Drug User Fee Act (PDUFA) goal date of
February 26, 2024. The FDA advised that it identified potential
review issues that had been previously cited in the refuse-to-file
decision letter, which included those discussed at the Type C
meeting in March 2022.
“The filing of the NDA is an important event for Minerva and a
step forward to our goal to treat those patients suffering negative
symptoms of schizophrenia. If approved, we believe roluperidone
could be an important new option to address the serious unmet need
faced by that group of patients with schizophrenia whose negative
symptoms are a major source of disability and adversely impact
their daily quality of life,” said Dr. Remy Luthringer, Executive
Chairman and Chief Executive Officer of Minerva.
About RoluperidoneRoluperidone is an
investigational drug that has been shown to block serotonin, sigma
and α-adrenergic receptors that are all involved in the regulation
of important brain functions, including mood, cognition, sleep, and
anxiety.
Roluperidone was designed to avoid a direct blockade of
dopaminergic receptors (the key pharmacological target for first-
and second-generation antipsychotics), while maintaining blockade
of a specific subtype of serotonin receptor called 5-HT2A (an
additional key target of second-generation antipsychotics) as well
as additional pharmacological targets (sigma2 and
adrenergic-α1A).
About Schizophrenia and Negative
SymptomsSchizophrenia is a chronic, severe, and
debilitating type of mental illness characterized by distortions in
thinking, perception, emotions, language, sense of self and
behavior. Schizophrenia affects 20 million people worldwide. (World
Health Organization).
Negative symptoms can cause individuals with schizophrenia to
withdraw from society, become disinterested or unable to complete
tasks or feel pleasure. Negative symptoms are characterized by five
constructs: blunted affect, alogia, avolition, anhedonia, and
asociality (Marder and Galderisi, 2017).
Negative symptoms are the main cause of the poor functional
outcome of patients suffering from schizophrenia (Harvey et al.,
2020) and may also be one of the main reasons ultra-high risk
adolescents may develop full blown schizophrenia (Gomes and Grace,
2017). There are currently no treatments approved for negative
symptoms of schizophrenia in the US.
Minerva believes that research continues to emerge indicating
that there is a large subgroup of patients with schizophrenia who
have moderate to severe primary negative symptoms and minimal
positive symptoms (Galderisi 2021) and have a low risk of
worsening of positive symptoms even in the absence of antipsychotic
treatments (Harrow 2013;
Moilanen 2016; Murray 2016; Wils 2017;
Wunderink 2013; Landolt 2016).
About Minerva NeurosciencesMinerva
Neurosciences, Inc. (Nasdaq: NERV) is a clinical-stage
biopharmaceutical company focused on developing product candidates
to treat central nervous system (CNS) diseases. Our goal is to
transform the lives of patients with improved therapeutic options.
Minerva’s portfolio of compounds includes roluperidone (MIN-101),
in clinical development for negative symptoms of schizophrenia, and
MIN-301 for Parkinson’s disease. For more information, please
visit our website.
Forward-Looking Safe Harbor StatementThis 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. These statements may be identified
by words such as “aims,” “anticipates,” “believes,” “could,”
“estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,”
“plans,” “possible,” “potential,” “seeks,” “will” and variations of
these words or similar expressions that are intended to identify
forward-looking statements, although not all forward-looking
statements contain these words. Forward-looking statements include,
but are not limited to, statements herein with respect to the
regulatory progress and therapeutic potential of roluperidone for
the treatment of negative symptoms in patients with schizophrenia.
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, whether the FDA
will require additional trials or data which may significantly
delay and put at risk our efforts to obtain regulatory approval;
whether the FDA may meet expected review timelines for our NDA;
whether roluperidone will be successfully marketed if approved;
management’s ability to successfully achieve its goals; our ability
to raise additional capital to fund our operations and corporate
objectives on terms acceptable to us; general economic conditions;
and other factors that are described under the caption “Risk
Factors” in our filings with the Securities and Exchange
Commission, including our Annual Report on Form 10-K for the year
ended December 31, 2022, filed with the Securities and
Exchange Commission on March 8, 2023. Copies of reports filed with
the SEC are posted on our website at
www.minervaneurosciences.com. The forward-looking statements in
this press release are based on information available to us as of
the date hereof, and we expressly disclaim any obligation to update
any forward-looking statements, except as required by law.
Contact:Investor
inquiries:Frederick AhlholmChief Financial OfficerMinerva
Neurosciences, Inc.Info@minervaneurosciences.com
Media inquiries: Helen ShikPrincipalShik
Communications LLCHelen@ShikCommunications.com
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