NERV MINERVA NEUROSCIENCES

Minerva Neurosciences Announces Update on its New Drug Application (NDA) for Roluperidone for the Treatment of Negative Symptoms in Schizophrenia

Minerva Neurosciences Announces Update on its New Drug Application (NDA) for Roluperidone for the Treatment of Negative Symptoms in Schizophrenia

BURLINGTON, Mass., Dec. 28, 2022 (GLOBE NEWSWIRE) -- (Nasdaq: NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system (CNS) disorders, today announced that, following the Type A meeting held on November 30, 2022, the Food and Drug Administration (FDA) has confirmed that the refuse to file letter dated October 14, 2022 remains in effect in respect of the Company’s New Drug Application (NDA) for roluperidone for the treatment of negative symptoms in patients with schizophrenia.

“We are very disappointed to announce that the FDA has confirmed that it will not file our NDA for roluperidone for the treatment of negative symptoms of schizophrenia,” said Dr. Remy Luthringer, Executive Chairman and Chief Executive Officer of Minerva. “We will continue to work with the FDA regarding their feedback and assess the next steps for roluperidone.”

About Schizophrenia and Negative Symptoms

Schizophrenia 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. ().

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 ().

Negative symptoms are the main cause of the poor functional outcome of patients suffering from schizophrenia () and may also be one of the main reasons ultra-high risk adolescents may develop full blown schizophrenia (). 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 () and have a low risk of worsening of positive symptoms even in the absence of antipsychotic treatments (; ;  ;  ; ; ).

About Minerva Neurosciences

Minerva 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

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. 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 in this press release include, but are not limited to, statements with respect to the clinical development of roluperidone as monotherapy for the treatment of negative symptoms of schizophrenia; the timing and outcomes of future interactions with U.S. and foreign regulatory bodies, including the FDA; and management’s ability to successfully achieve its goals. 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 our future interactions with the FDA will have satisfactory outcomes; whether and when, if at all, our NDA for roluperidone will be approved by the FDA; whether the FDA will require additional trials or data which may significantly delay and put at risk our efforts to obtain approval and may not be successful; management’s ability to successfully achieve its goals; our ability to raise additional capital to fund our operations on terms acceptable to us; and general economic conditions. Other factors that may cause our actual results to differ from those expressed or implied in the forward-looking statements in this press release are identified under the caption “Risk Factors” in our filings with the Securities and Exchange Commission, including our Quarterly Report on Form 10-Q for the quarter ended September 30, 2022, filed with the Securities and Exchange Commission on November 9, 2022. Copies of reports filed with the SEC are posted on our website at . 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 Ahlholm

Chief Financial Officer

Minerva Neurosciences, Inc.

Media inquiries:

Helen Shik

Principal

Shik Communications LLC



EN
28/12/2022

Underlying

To request access to management, click here to engage with our
partner Phoenix-IR's CorporateAccessNetwork.com

Reports on MINERVA NEUROSCIENCES

 PRESS RELEASE

Minerva Neurosciences Reports First Quarter 2025 Financial Results and...

Minerva Neurosciences Reports First Quarter 2025 Financial Results and Business Updates BURLINGTON, Mass., May 13, 2025 (GLOBE NEWSWIRE) --  (Nasdaq: NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system disorders, today reported business updates and financial results for the first quarter of 2025 ended on March 31, 2025.    Corporate Update On March 17, 2025, we were formally notified by Nasdaq that we had regained compliance with Nasdaq Listing Rule 5550(b)(3), and as such, will continue to be listed on the Nasdaq...

 PRESS RELEASE

Minerva Neurosciences Reports Fourth Quarter and Fiscal Year 2024 Fina...

Minerva Neurosciences Reports Fourth Quarter and Fiscal Year 2024 Financial Results and Business Updates BURLINGTON, Mass., Feb. 25, 2025 (GLOBE NEWSWIRE) --  (Nasdaq: NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system disorders, today reported business updates and financial results for the fourth quarter and year ended December 31, 2024.    Corporate Update As previously in the first quarter of 2024, the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to our New Drug Application (NDA...

 PRESS RELEASE

Minerva Neurosciences Reports Third Quarter 2024 Financial Results and...

Minerva Neurosciences Reports Third Quarter 2024 Financial Results and Business Updates BURLINGTON, Mass., Nov. 05, 2024 (GLOBE NEWSWIRE) -- (Nasdaq: NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system (CNS) disorders, today reported business updates and financial results for the third quarter of 2024 ending September 30, 2024.    Roluperidone NDA Update As in February 2024, the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to our New Drug Application (NDA) for roluperidone (f/k/a M...

 PRESS RELEASE

Minerva Neurosciences Reports Second Quarter 2024 Financial Results an...

Minerva Neurosciences Reports Second Quarter 2024 Financial Results and Business Updates BURLINGTON, Mass., Aug. 06, 2024 (GLOBE NEWSWIRE) -- (Nasdaq: NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system (CNS) disorders, today reported business updates and financial results for the second quarter of 2024 ending June 30, 2024. Roluperidone NDA Update During the first quarter of this year, the Company that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to its New Drug Applicatio...

 PRESS RELEASE

Minerva Neurosciences Reports First Quarter 2024 Financial Results and...

Minerva Neurosciences Reports First Quarter 2024 Financial Results and Business Updates BURLINGTON, Mass., May 01, 2024 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (Nasdaq: NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system (CNS) disorders, today reported business updates and financial results for the first quarter of 2024 ending March 31, 2024. Roluperidone NDA Update On February 27, 2024, the Company that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to its New Drug Applic...

ResearchPool Subscriptions

Get the most out of your insights

Get in touch