NERV

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

Retrieved on: 
Tuesday, February 27, 2024
NERV, CRL, Myenteric plexus, FDA, Food, Biopharmaceutical, Schizophrenia, Roluperidone, Symantec Endpoint Protection, Safety, Patient, Neuroscience, NDA, Pharmaceutical industry

The NDA submission lacks data needed to establish that the change in negative symptoms of schizophrenia with roluperidone treatment was clinically meaningful.

Key Points: 
  • The NDA submission lacks data needed to establish that the change in negative symptoms of schizophrenia with roluperidone treatment was clinically meaningful.
  • The submitted safety database included an inadequate number of subjects exposed to roluperidone at the proposed dose (64 mg) for at least 12 months.
  • To address these deficiencies, the FDA stated that Minerva must submit at least one additional positive, adequate, and well-controlled study to support the safety and effectiveness of roluperidone for the treatment of negative symptoms.
  • “There is a critical need for a treatment for the negative symptoms of schizophrenia.

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

Retrieved on: 
Thursday, February 22, 2024
Research, NERV, Myenteric plexus, FDA, Physician, Food, File, Schizophrenia, Sale, PDUFA, Roluperidone, Patient, G&A, Neuroscience, NDA, Insurance, Pharmaceutical industry

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 central nervous system disorders, today reported business updates and financial results for the fourth quarter and year ended December 31, 2023.

Key Points: 
  • 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 central nervous system disorders, today reported business updates and financial results for the fourth quarter and year ended December 31, 2023.
  • Research and development (R&D) expense: For the three months ended December 31, 2023 and 2022, R&D expense was $4.7 million and $3.2 million, respectively.
  • For the years ended December 31, 2023 and 2022, R&D expense was $12.7 million and $14.6 million, respectively.
  • Cash Position: Cash, cash equivalents and restricted cash at December 31, 2023, were approximately $41.0 million, as compared to $36.2 million at December 31, 2022.

Minerva Neurosciences Reports 2023 Third Quarter Financial Results and Business Updates

Retrieved on: 
Tuesday, November 7, 2023
FDA, Research, Sale, Food, Physician, G&A, Neuroscience, Regulation of tobacco by the U.S. Food and Drug Administration, NERV, R, Roluperidone, Schizophrenia, New Drug Application, NDA, Patient, Myenteric plexus, Pharmaceutical industry

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 central nervous system disorders, today reported business updates and financial results for the third quarter ended September 30, 2023.

Key Points: 
  • 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 central nervous system disorders, today reported business updates and financial results for the third quarter ended September 30, 2023.
  • Research and development (R&D) expense: For the three months ended September 30, 2023 and 2022, R&D expense was $3.4 million and $2.4 million, respectively.
  • For the nine months ended September 30, 2023 and 2022, R&D expense was $8.0 million and $11.5 million, respectively.
  • For the nine months ended September 30, 2023 and 2022, non-cash interest expense was $6.1 million and $5.5 million, respectively.

Mitsubishi Motors Booth to Inspire Drivers' Adventurous Spirit at the Japan Mobility Show 2023

Retrieved on: 
Thursday, October 19, 2023
Weather, Tokyo Big Sight, Life, Adventure, Family, Emergency, Sky Campus, Mitsubishi Delica, NERV, Mitsubishi Motors, Friends, Mitsubishi Outlander, Outlander, Leisure, Yamaha Corporation, MPV, Amusement park, Yamaha

TOKYO, Oct 19, 2023 - (JCN Newswire) - Mitsubishi Motors Corporation (hereafter, Mitsubishi Motors) will exhibit at the Japan Mobility Show 2023(1) with the booth theme of "Awaken the adventurous spirit within you.

Key Points: 
  • TOKYO, Oct 19, 2023 - (JCN Newswire) - Mitsubishi Motors Corporation (hereafter, Mitsubishi Motors) will exhibit at the Japan Mobility Show 2023(1) with the booth theme of "Awaken the adventurous spirit within you.
  • Adventures for all - anytime and anywhere" to inspire drivers' spirit of adventure in a variety of settings, from everyday life to uncharted lands.
  • With a sculpted design inspired by mountain ranges, the Unexplored Adventures Area will feature Mitsubishi Motors' electrified crossover MPV concept car which will make its global debut at the Japan Mobility Show.
  • Demonstrations will be held for visitors to experience the first-class quality sound developed by Mitsubishi Motors and Yamaha.

Minerva Neurosciences Reports 2023 Second Quarter Financial Results and Business Updates

Retrieved on: 
Tuesday, August 1, 2023
Insurance, Roluperidone, NERV, Schizophrenia, NDA, G&A, Federated Hermes, Sale, Boehringer Ingelheim, Patient, Physician, Myenteric plexus, Neuroscience, PDUFA, Research, FDA, Pharmaceutical industry, Cryptocurrency

BURLINGTON, Mass., Aug. 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 disorders, today reported business updates and financial results for the second quarter ended June 30, 2023.

Key Points: 
  • BURLINGTON, Mass., Aug. 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 disorders, today reported business updates and financial results for the second quarter ended June 30, 2023.
  • “In the second quarter, we completed an equity financing of $20.0 million, further strengthening our cash position.
  • Roluperidone, if approved, would be the first medication for negative symptoms of schizophrenia, a recognized unmet clinical need,” said Dr. Remy Luthringer, Executive Chairman and Chief Executive Officer of Minerva.
  • On May 8, 2023 , the FDA confirmed that they had assigned a Prescription Drug User Fee Act (PDUFA) goal date of February 26, 2024.

Minerva Neurosciences Announces $20 Million in Private Placement Priced at a Premium to Market

Retrieved on: 
Wednesday, June 28, 2023
Roluperidone, NERV, Schizophrenia, PIPE, The Act, Sale, Boehringer Ingelheim, Myenteric plexus, Neuroscience, Security (finance)

Minerva expects that the gross proceeds from the PIPE will be approximately $20 million, before deducting PIPE-related expenses payable by Minerva.

Key Points: 
  • Minerva expects that the gross proceeds from the PIPE will be approximately $20 million, before deducting PIPE-related expenses payable by Minerva.
  • Minerva intends to use the net proceeds from the PIPE to support potential regulatory approval in the U.S., commercialization activities and market launch of roluperidone, which is being developed for the treatment of negative symptoms in schizophrenia.
  • The PIPE is expected to close on or about June 30, 2023, subject to the satisfaction of customary closing conditions.
  • Under the terms of the PIPE, Boehringer Ingelheim will have the right to designate one individual to attend all meetings of Minerva’s board of directors or any committee thereof in a non-voting, observer capacity.

Minerva Neurosciences Reports 2023 First Quarter Financial Results and Business Updates

Retrieved on: 
Monday, May 15, 2023
Insurance, Roluperidone, Small business, NERV, Schizophrenia, Federal Food, Drug, and Cosmetic Act, New Drug Application, NDA, RTF, G&A, Research, Sale, Waste, Patient, Physician, Myenteric plexus, Neuroscience, PDUFA, R, FDA, Regulation of tobacco by the U.S. Food and Drug Administration, Food, Caregiver, Pharmaceutical industry, Cryptocurrency

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.

Key Points: 
  • 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 Company submitted a Formal Dispute Resolution Request (FDRR) on March 2, 2023, and met with the FDA on March 28, 2023.
  • On May 8, 2023 , the FDA confirmed that they had assigned a PDUFA goal date of February 26, 2024.
  • In January 2023 we received a refund of our NDA filing fee of $3.1 million from the FDA.

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

Retrieved on: 
Wednesday, May 10, 2023
Central nervous system, NERV, Classification, Schizophrenia, Disability, NDA, Quality of life, Type, CNS, Patient, Neuroscience, PDUFA, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Pharmaceutical industry, BURLINGTON

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. 

Key Points: 
  • 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.

Minerva Neurosciences to Report First Quarter 2023 Financial Results and Business Updates on May 15, 2023

Retrieved on: 
Monday, May 8, 2023
Neuroscience, Central nervous system, NERV, CNS, Pharmaceutical industry

BURLINGTON, Mass., May 08, 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 it will release first quarter 2023 financial results and business updates on Monday, May 15, 2023.

Key Points: 
  • BURLINGTON, Mass., May 08, 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 it will release first quarter 2023 financial results and business updates on Monday, May 15, 2023.
  • The Company will host a webcast that day at 8:30 a.m. Eastern Time to discuss the results and updates.
  • The live conference call 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.

Minerva Neurosciences Announces the NDA Filing for Roluperidone for the Treatment of Negative Symptoms in Schizophrenia

Retrieved on: 
Monday, May 1, 2023
Central nervous system, NERV, Schizophrenia, Disability, NDA, Quality of life, CNS, Patient, Physician, Psychiatry, Neuroscience, Behavioural sciences, FDA, Regulation of tobacco by the U.S. Food and Drug Administration, Food, Caregiver, Disease, Pharmaceutical industry, Medicine

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.

Key Points: 
  • 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.
  • “We thank the FDA for its thoughtful review and consideration of our materials submitted during the formal dispute resolution process.
  • “Negative symptoms are a major source of disability in people with schizophrenia and there have been no approved treatments to date.