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Minerva Neurosciences Inc

Minerva Neurosciences Inc (NERV)

2.4038
-0.0362
(-1.48%)
At close: May 29 4:00PM
2.4038
-0.0362
( -1.48% )
After Hours: 4:36PM

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Key stats and details

Current Price
2.4038
Bid
2.47
Ask
2.48
Volume
4,230
2.375 Day's Range 2.49
2.2864 52 Week Range 13.49
Market Cap
Previous Close
2.44
Open
2.41
Last Trade
10
@
2.47
Last Trade Time
Financial Volume
$ 10,305
VWAP
2.4363
Average Volume (3m)
32,136
Shares Outstanding
6,993,406
Dividend Yield
-
PE Ratio
-0.56
Earnings Per Share (EPS)
-4.29
Revenue
-
Net Profit
-30.01M

About Minerva Neurosciences Inc

Minerva Neurosciences, Inc. (Nasdaq: NERV) is a clinical-stage biopharmaceutical company focused on the development of product candidates to treat patients suffering from central nervous system diseases. Minerva is developing roluperidone for the treatment of negative symptoms in patients with schiz... Minerva Neurosciences, Inc. (Nasdaq: NERV) is a clinical-stage biopharmaceutical company focused on the development of product candidates to treat patients suffering from central nervous system diseases. Minerva is developing roluperidone for the treatment of negative symptoms in patients with schizophrenia and has exclusive rights to develop MIN-301 for the treatment of Parkinson's disease. Minerva co-developed seltorexant with Janssen Pharmaceutica NV for the treatment of insomnia disorder and adjunctive treatment of Major Depressive Disorder.Minerva has not received any regulatory approvals to commercialize its product candidates and has not generated any revenue from the sales or license of any product candidates. Minerva has incurred significant operating losses since inception and expects to continue to incur net losses and negative cash flows from operating activities for the foreseeable future in connection with clinical and regulatory activities. Show more

Sector
Pharmaceutical Preparations
Industry
Pharmaceutical Preparations
Headquarters
Wilmington, Delaware, USA
Founded
1970
Minerva Neurosciences Inc is listed in the Pharmaceutical Preparations sector of the NASDAQ with ticker NERV. The last closing price for Minerva Neurosciences was $2.44. Over the last year, Minerva Neurosciences shares have traded in a share price range of $ 2.2864 to $ 13.49.

Minerva Neurosciences currently has 6,993,406 shares outstanding. The market capitalization of Minerva Neurosciences is $16.78 million. Minerva Neurosciences has a price to earnings ratio (PE ratio) of -0.56.

NERV Latest News

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...

Minerva Neurosciences Receives Complete Response Letter from FDA for New Drug Application for Roluperidone for the Treatment of Negative Symptoms in Patients with Schizophrenia

BURLINGTON, Mass., Feb. 27, 2024 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (Nasdaq: NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat...

Minerva Neurosciences Reports Fourth Quarter and Fiscal Year 2023 Financial Results and Business Updates

BURLINGTON, Mass., Feb. 22, 2024 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (Nasdaq: NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat...

Minerva Neurosciences Reports 2023 Third Quarter Financial Results and Business Updates

BURLINGTON, Mass., Nov. 07, 2023 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (Nasdaq: NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat...

PeriodChangeChange %OpenHighLowAvg. Daily VolVWAP
1-0.0162-0.6694214876032.422.5452.35156132.45810274CS
40.07383.167381974252.332.622.312135912.44971134CS
12-0.2262-8.600760456272.632.922.2864321362.65029387CS
26-3.1962-57.0755.613.492.2864722924.7937416CS
52-3.5562-59.66778523495.9613.492.28642754869.33964997CS
156-0.5462-18.51525423732.9515.270.3278847732227.34774678CS
260-2.7862-53.68400770715.1915.270.3278848849955.8818704CS

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NERV Discussion

View Posts
Monksdream Monksdream 1 month ago
NERV under $3
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Monksdream Monksdream 2 months ago
NERV under $3
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TheFinalCD TheFinalCD 3 months ago
I got some nerv buying 2.17 selling 2.68
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TheFinalCD TheFinalCD 3 months ago
SOME $NERV https://finance.yahoo.com/news/minerva-neurosciences-receives-complete-response-130000303.html?guccounter=1&guce_referrer=aHR0cHM6Ly9maW52aXouY29tLw&guce_referrer_sig=AQAAAK4u41gCrkp36V9J1KnqxXYmY-pDJHov944hXd73IMozX0-dLZ2JadJjbZE5NOvjWI0OqAQiT0EdWVZXKTmG6LEj8AltTn_0OVLCOooaCGR0jqjPSqzu4rxgazc7xoZMfW7mwM1k5R91Oqx2YUpTKIpdj-ws0s0VbJcMYVSFAtL7

@Maximus_Holla HALT 02/27/2024
07:55:00$NERV
Minerva Neurosciences CmnNASDAQ
T1https://t.co/U4ZmAtIJ0u— THE FINAL COUNTDOWN (@READY_2_PROFIT) February 27, 2024
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Sierra20 Sierra20 3 months ago
Idiot lol
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subslover subslover 11 months ago
PTPI will be running just as high as NERV now at $13.17
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subslover subslover 11 months ago
$12.25
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subslover subslover 11 months ago
Look how this baby quietly snuck back up all of last week to today all on low volume. Didn't come down crashing like most of those other PUMP & DUMPS.
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subslover subslover 11 months ago
Hey TFC, I am just beaming today. I had loaded the boat all the way below $2.00. This kind of news always sends stocks sliding down but the total opposite took place.No doubt in my mind that unknown sources are at work every day with a few daily NASDAQ pumps.
Shorting this one will begin once the public float becomes diluted from the PP. If you do short than GLTY and be careful because these stocks are highly schizophrenic lol
👍️0
TheFinalCD TheFinalCD 11 months ago
wow you went long on this whacky news amazing, I want to short above $10, but could squeeze like a banshee

Message in reply to:
$NERV = $10.10! This is total insanity! I'm not complaining as I am having a HUGE payday. Take a look at the news and tell me why>lol
👍️0
subslover subslover 11 months ago
$NERV = $10.10! This is total insanity! I'm not complaining as I am having a HUGE payday. Take a look at the news and tell me why>lol
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TheFinalCD TheFinalCD 11 months ago
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=172228338&txt2find=nerv
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subslover subslover 11 months ago
PUMP IT BROTHER LOL!!!!!!
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starkd748 starkd748 11 months ago
Kabooom
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subslover subslover 11 months ago
Been loading for 2 months and am so ready to make BANK!
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Awl416 Awl416 11 months ago
Minerva Neurosciences Announces $20 Million in Private Placement Priced at a Premium to Market
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starkd748 starkd748 11 months ago
Yeeehaw
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subslover subslover 12 months ago
Showing signs of northward-bound movement today. Volume picking up as well
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subslover subslover 1 year ago
Back over $7.00
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starkd748 starkd748 1 year ago
Waiting for a re entry
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subslover subslover 1 year ago
Minerva Neurosciences Reports 2023 First Quarter Financial Results and Business Updates
Company to host conference call today at 8:30 a.m. ET
BURLINGTON, Mass., May 15, 2023 (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 reported business updates and financial results for the first quarter ended March 31, 2023.

“The first quarter saw the achievement of a significant milestone for our investigational drug, roluperidone, and for Minerva, as the U.S. Food and Drug Administration (FDA) filed our New Drug Application (NDA) for roluperidone for the treatment of negative symptoms of schizophrenia on April 27, 2023. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of February 26, 2024. We believe roluperidone has a unique mechanism of action and is intended to treat a group of patients that, to date, have not had an approved treatment. This is a completely new approach to treating negative symptoms of schizophrenia and we look forward to continuing to work with the FDA as they undertake their review.

“Successfully treating the negative symptoms of schizophrenia has historically been a significant challenge. If approved, roluperidone will be the first approved treatment for negative symptoms of schizophrenia in the U.S. We believe it has the potential to beneficially impact patients’ quality of life, reduce the burden on families and caregivers and provide physicians with a new treatment option,” said Dr. Remy Luthringer, Executive Chairman and Chief Executive Officer of Minerva.

Recent Business Highlights

The Company submitted a Formal Dispute Resolution Request (FDRR) on March 2, 2023, and met with the FDA on March 28, 2023. At the meeting the Company presented a detailed summary of data to address the issues raised in the Refuse to File letter (RTF) received by the Company in October 2022.
On April 27, 2023, the FDA confirmed filing of Minerva’s NDA for roluperidone for the treatment of negative symptoms in patients with schizophrenia.
On May 8, 2023, the FDA confirmed that they had assigned a PDUFA goal date of February 26, 2024.
First Quarter 2023 Financial Results

Research and development (R&D) expense: Research and development expenses were $2.7 million and $5.0 million for the three months ended March 31, 2023 and 2022, respectively, a decrease of approximately $2.3 million. The decrease in research and development expenses was primarily due to lower non-cash stock compensation costs, and lower consultant and contractor fees related to the NDA that was submitted during 2022. Non-cash stock compensation expense included in research and development expenses was $0.2 million and $0.5 million for the three months ended March 31, 2023 and 2022, respectively.
General and administrative (G&A) expense: General and administrative expenses were $2.7 million and $3.0 million for the three months ended March 31, 2023 and 2022, respectively, a decrease of approximately $0.3 million. The decrease in general and administrative expenses was primarily due to lower non-cash stock compensation costs and lower insurance costs. Non-cash stock compensation expense included in general and administrative expenses was $0.2 million and $0.6 million for the three months ended March 31, 2023 and 2022, respectively.
Non-cash interest expense: For the three months ended March 31, 2023 and 2022 we recognized non-cash interest expense of $2.0 million and $1.8 million, respectively, an increase of $0.2 million. The increase was primarily due to an increase in the carrying value of the liability related to the sale of future royalties for seltorexant to Royalty Pharma, for which upfront milestone payments are being amortized under the interest method over the estimated life of the agreement.
Net loss: Net loss for the first quarter ended March 31, 2023 was $7.0 million, or a loss per share of $1.31 (basic and diluted), as compared to a net loss of $9.8 million for the first quarter ended March 31, 2022, or a loss per share of $1.83 (basic and diluted).
Cash Position: Cash, cash equivalents, and restricted cash as of March 31, 2023 were approximately $36.1 million, compared to $36.2 million as of December 31, 2022. In January 2023 we received a refund of our NDA filing fee of $3.1 million from the FDA. This refund was made in accordance with the Federal Food Drug and Cosmetic Act, which allows a fee waiver for a small business submitting its first human drug application.
Conference Call Information:

The live conference call will begin this morning at 8:30 a.m. ET and may be accessed here and on the Company’s website under Events and Presentations.

The archived webcast will be available on the Company’s website beginning approximately two hours after the event for 90 days.

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), for negative symptoms of schizophrenia, and MIN-301, for Parkinson’s disease. For more information, please visit our website.

Forward-Looking Safe Harbor Statement
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subslover subslover 1 year ago
NERV ==Beautiful close $7.73
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starkd748 starkd748 1 year ago
Weeee
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subslover subslover 1 year ago
Minerva Neurosciences Announces Update on its New Drug Application (NDA) for Roluperidone for the Treatment of Negative Symptoms in Schizophrenia
FDA confirms acceptance of the filing of the NDA for roluperidone

Application has been granted a standard review

FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of February 26, 2024

BURLINGTON, Mass., May 10, 2023 (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 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 a-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-a1A).

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. (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 Ahlholm
Chief Financial Officer
Minerva Neurosciences, Inc.
Info@minervaneurosciences.com

Media inquiries:
Helen Shik
Principal
Shik Communications LLC
Helen@ShikCommunications.com

https://www.globenewswire.com/newsroom/ti?nf=ODgzNTczNCM1NTg1NDAyIzIwMDcyNDU=
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Source: Minerva Neurosciences, Inc
© 2023 GlobeNewswire, Inc.

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Other Financial Information
Recent News & Disclosure Filings
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Awl416 Awl416 1 year ago
Minerva Neurosciences Announces Update on its New Drug Application (NDA) for Roluperidone for the Treatment of Negative Symptoms in Schizophrenia
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starkd748 starkd748 1 year ago
Bong and again
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subslover subslover 1 year ago
Closed $6.00 up 32%. HOD $6.52 making for a weekly gain @ HOD of 87.2%
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subslover subslover 1 year ago
Over $6.00 at this writing! Holy smokes lol
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subslover subslover 1 year ago
Back over $5.00
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subslover subslover 1 year ago
Fractional gain today indicates we are holding the muster test.
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subslover subslover 1 year ago
Another very very nice day here in NERV land
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subslover subslover 1 year ago
$NERV she is starting to get a bit frisky again.
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subslover subslover 1 year ago
$NERV $5.75 up over 100% so far today!
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starkd748 starkd748 1 year ago
Weeeee
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subslover subslover 1 year ago
Minerva Neurosciences Announces the NDA Filing for Roluperidone for the Treatment of Negative Symptoms in Schizophrenia
FDA grants appeal and files NDA
BURLINGTON, Mass., May 01, 2023 (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 announced that the U.S. Food and Drug Administration (FDA) filed the Company’s New Drug Application (NDA) for roluperidone for the treatment of negative symptoms in patients with schizophrenia on April 27, 2023. The decision to file the NDA follows the Company’s request for formal dispute resolution and appeal of FDA’s October 2022 refuse to file letter. The issues cited in the refuse-to-file decision included those discussed at the type C meeting in April 2022. In granting the appeal, the FDA deciding official agreed with the Company that the issues cited in the refuse-to-file decision should be considered during FDA’s review of the NDA.

“We thank the FDA for its thoughtful review and consideration of our materials submitted during the formal dispute resolution process. We look forward to continuing to work with the FDA with the ultimate goal of obtaining approval of roluperidone as the first approved treatment for negative symptoms of schizophrenia for the benefit of patients, their families, caregivers, and physicians,” said Dr. Remy Luthringer, Executive Chairman and Chief Executive Officer of Minerva.

“Negative symptoms are a major source of disability in people with schizophrenia and there have been no approved treatments to date. An approved treatment for negative symptoms could revolutionize the treatment of schizophrenia and would certainly have a major impact on the quality of life of the millions of people affected with this disease,” said Dr. Philip Harvey, Leonard M. Miller Professor of Psychiatry and Behavioral Sciences and Director of the Division of Psychology at the University of Miami Miller School of Medicine.

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. (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 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 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. 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.

Contacts:
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starkd748 starkd748 2 years ago
I sold stochastic rsi hit 100 then I flip yesterday no interest now needs to start all over
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frans frans 2 years ago
sell off all on last friday on the up at 13.6
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starkd748 starkd748 2 years ago
Nice scalp daytrade tho....Just flipped 4s could resist its oversold lol
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starkd748 starkd748 2 years ago
No top in Fri
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subslover subslover 2 years ago
Here is the news and it's very bad! :(
Minerva Neurosciences Receives Refusal to File Letter from FDA for its New Drug Application for Roluperidone for the Treatment of Negative Symptoms in Schizophrenia
October 17 2022 - 08:30AM
GlobeNewswire Inc.
Alert
Print
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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 (CNS) disorders, today announced that the company has received a refusal to file letter from the U.S. Food and Drug Administration (FDA) regarding the company’s New Drug Application (NDA) for roluperidone for the treatment of negative symptoms in patients with schizophrenia. The FDA has indicated that the company can request a Type A meeting to discuss the content of the refusal to file letter.
“We are disappointed that the FDA has not accepted our NDA for roluperidone. Our goal remains to provide a new and much needed therapeutic option to help patients and their families, since there are currently no approved therapies to treat negative symptoms of schizophrenia in the United States,” said Remy Luthringer, Executive Chairman and Chief Executive Officer of Minerva. “The company intends to request a Type A meeting and looks forward to continued discussions with the FDA.”

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. (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). The unmet medical need for treatments for this subgroup of patients is large.

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 website.

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frans frans 2 years ago
some news is in
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starkd748 starkd748 2 years ago
Weeeeee
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frans frans 2 years ago
hope we should see shortly some good news
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starkd748 starkd748 2 years ago
Weeeee
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starkd748 starkd748 2 years ago
In the power zone load n hold
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subslover subslover 2 years ago
NERV can go in the blink of an eye!
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frans frans 2 years ago
no more back here
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subslover subslover 2 years ago
Load load the boat gently down the stream, anything under $9.00 is a dream!
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subslover subslover 2 years ago
Hope you're loaded on NERV.
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subslover subslover 2 years ago
He doesn't post on any social media outlet however he knows stocks well.
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