Antipsychotics

Newron Initiates First Potentially Pivotal Study with Evenamide in Patients with Schizophrenia

Retrieved on: 
Monday, September 6, 2021
Mental Health, Research, FDA, Clinical Trials, Biotechnology, Health, Pharmaceutical, General Health, Science, Psychiatry, Branches of biology, Abnormal psychology, Psychopathology, Sodium channel blockers, Schizophrenia, Antipsychotics, Evenamide, Phenethylamines, Atypical antipsychotic, Management of schizophrenia, Safinamide

Newron Pharmaceuticals S.p.A. (Newron) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system, today announced the initiation of Study 008A, the first potentially pivotal study with evenamide in patients with schizophrenia.

Key Points: 
  • Newron Pharmaceuticals S.p.A. (Newron) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system, today announced the initiation of Study 008A, the first potentially pivotal study with evenamide in patients with schizophrenia.
  • This study is part of Newrons Phase III evenamide clinical trial program that targets patients with schizophrenia experiencing worsening of psychosis on therapeutic doses of atypical antipsychotics, as well as treatment-resistant patients.
  • If successful, Newron believes the study would qualify as the first adequate and well-controlled (pivotal) study with evenamide in patients with schizophrenia who are inadequate responders to antipsychotics.
  • Newron is developing evenamide as the potential first add-on therapy for the treatment of patients with positive symptoms of schizophrenia.

DGAP-News: Newron Initiates First Potentially Pivotal Study with Evenamide in Patients with Schizophrenia

Retrieved on: 
Monday, September 6, 2021
Psychiatry, Abnormal psychology, Branches of biology, Psychopathology, Schizophrenia, Antipsychotics, Evenamide, Phenethylamines, Atypical antipsychotic, Management of schizophrenia, Psychosis

Newron plans to randomize at least 200 patients in study centers in Europe, Asia and Latin America.

Key Points: 
  • Newron plans to randomize at least 200 patients in study centers in Europe, Asia and Latin America.
  • This study is part of Newron's Phase III evenamide clinical trial program that targets patients with schizophrenia experiencing worsening of psychosis on therapeutic doses of atypical antipsychotics, as well as treatment-resistant patients.
  • If successful, Newron believes the study would qualify as the first adequate and well-controlled (pivotal) study with evenamide in patients with schizophrenia who are inadequate responders to antipsychotics.
  • Newron is developing evenamide as the potential first add-on therapy for the treatment of patients with positive symptoms of schizophrenia.

Minerva Neurosciences to Present at JMP Securities Life Sciences Conference

Retrieved on: 
Thursday, June 10, 2021
Data management, Chemical compounds, 5-HT2A antagonists, Antipsychotics, Ketones, Organofluorides, Piperidines, Roluperidone, NERV, NASDAQ, Schizophrenia, JMP

WALTHAM, Mass., June 10, 2021 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (NASDAQ: NERV), a clinical-stage biopharmaceutical company focused on the development of innovative therapies to treat central nervous system (CNS) disorders, today announced that it will participate in the virtual JMP Securities Life Sciences Conference on June 16, 2021 at 10:00 a.m. Eastern Time.

Key Points: 
  • WALTHAM, Mass., June 10, 2021 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (NASDAQ: NERV), a clinical-stage biopharmaceutical company focused on the development of innovative therapies to treat central nervous system (CNS) disorders, today announced that it will participate in the virtual JMP Securities Life Sciences Conference on June 16, 2021 at 10:00 a.m. Eastern Time.
  • The presentation will be webcast and accessible on a live and archived basis through the investor relations section of the Companys web site, http://ir.minervaneurosciences.com .
  • Minervas portfolio of compounds includes: roluperidone (MIN-101), in clinical development for schizophrenia, and MIN-301, in pre-clinical development for Parkinsons disease.
  • Minervas common stock is listed on the NASDAQ Global Market under the symbol NERV.For more information, please visit www.minervaneurosciences.com .

Minerva Neurosciences to Present at Jefferies Virtual Healthcare Conference

Retrieved on: 
Friday, May 28, 2021
Chemical compounds, 5-HT2A antagonists, Antipsychotics, Ketones, Organofluorides, Piperidines, Roluperidone, NERV, Schizophrenia, Chemistry

WALTHAM, Mass., May 28, 2021 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (NASDAQ: NERV), a clinical-stage biopharmaceutical company focused on the development of innovative therapies to treat central nervous system (CNS) disorders, today announced that it will participate in the Jefferies Virtual Healthcare Conference on June 2, 2021 at 11:00 a.m. Eastern Time.

Key Points: 
  • WALTHAM, Mass., May 28, 2021 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (NASDAQ: NERV), a clinical-stage biopharmaceutical company focused on the development of innovative therapies to treat central nervous system (CNS) disorders, today announced that it will participate in the Jefferies Virtual Healthcare Conference on June 2, 2021 at 11:00 a.m. Eastern Time.
  • The presentation will be webcast and accessible on a live and archived basis through the investor relations section of the Companys web site, http://ir.minervaneurosciences.com .
  • Minervas portfolio of compounds includes: roluperidone (MIN-101), in clinical development for schizophrenia, and MIN-301, in pre-clinical development for Parkinsons disease.
  • Minervas common stock is listed on the NASDAQ Global Market under the symbol NERV.For more information, please visit www.minervaneurosciences.com .

Newron Announces Paragraph IV ANDA Filings for Xadago® (safinamide) in the USA

Retrieved on: 
Thursday, May 20, 2021
Biotechnology, FDA, Health, Pharmaceutical, Clinical trials, Sodium channel blockers, Antipsychotics, Evenamide, Phenethylamines, Schizophrenia, Branches of biology, Drugs, Chemistry

Supernus Pharmaceuticals holds the commercialization rights in the USA.

Key Points: 
  • Supernus Pharmaceuticals holds the commercialization rights in the USA.
  • Meiji Seika has the rights to develop and commercialize the compound in Japan and other key Asian territories.
  • Newron is also developing evenamide as the potential first add-on therapy for the treatment of patients with positive symptoms of schizophrenia.
  • Newron may not actually achieve the plans, intentions or expectations disclosed in forward-looking statements and assumptions underlying any such statements may prove wrong.

Newron Announces Paragraph IV ANDA Filing for Xadago® (safinamide) in the USA

Retrieved on: 
Tuesday, May 4, 2021
Science, Other Science, Biotechnology, Research, Pharmaceutical, Health, FDA, Clinical trials, Sodium channel blockers, Antipsychotics, Evenamide, Phenethylamines, Schizophrenia, Branches of biology, Drugs, Chemistry

Supernus Pharmaceuticals holds the commercialization rights in the USA.

Key Points: 
  • Supernus Pharmaceuticals holds the commercialization rights in the USA.
  • Meiji Seika has the rights to develop and commercialize the compound in Japan and other key Asian territories.
  • Newron is also developing evenamide as the potential first add-on therapy for the treatment of patients with positive symptoms of schizophrenia.
  • Newron may not actually achieve the plans, intentions or expectations disclosed in forward-looking statements and assumptions underlying any such statements may prove wrong.

Sunovion Highlights Data from Its Late-Stage Psychiatric Medicine Pipeline at the American College of Neuropsychopharmacology (ACNP) Annual Meeting 2020

Retrieved on: 
Thursday, December 10, 2020
Biotechnology, Mental health, Health, Pharmaceutical, Clinical trials, Antipsychotics, SEP-363856, Thiophenes, Management of schizophrenia, Sunovion, Medicine, Psychiatry, Clinical medicine, SEP-363856, Schizophrenia, SEP-4199, Bipolar Disorder, Sunovion Pharmaceuticals Inc. (Sunovion), Sumitomo Dainippon Pharma Co., Ltd.

Sunovion Pharmaceuticals Inc. (Sunovion) today announced that new data and analyses of late-stage compounds SEP-363856 and SEP-4199 were presented at the 59th Annual Meeting of the American College of Neuropsychopharmacology virtual meeting, which took place December 6-9.

Key Points: 
  • Sunovion Pharmaceuticals Inc. (Sunovion) today announced that new data and analyses of late-stage compounds SEP-363856 and SEP-4199 were presented at the 59th Annual Meeting of the American College of Neuropsychopharmacology virtual meeting, which took place December 6-9.
  • We look forward to continuing clinical investigation of these important compounds and sharing additional data in the future.
  • Continued negative symptom improvements were observed during 26 weeks of additional treatment with SEP-363856 on the BNSS total score and other negative symptom assessments.
  • SEP-363856 is a TAAR1 agonist with 5-HT1A agonist activity that is under investigation for the treatment of schizophrenia and other psychiatric conditions.

DGAP-News: Newron Pharmaceuticals provides clinical and business update

Retrieved on: 
Tuesday, August 11, 2020
Health, Medical research, Sodium channel blockers, Antipsychotics, Evenamide, Phenethylamines, Clinical research, Pharmaceutical industry, Clinical trial

All evenamide pre-clinical studies requested by FDA completed and first clinical safety study initiated; on track to initiate evenamide Phase III program in 2021

Key Points: 
  • All evenamide pre-clinical studies requested by FDA completed and first clinical safety study initiated; on track to initiate evenamide Phase III program in 2021
    Milan, Italy and Morristown, NJ, USA, August 11, 2020 - Newron Pharmaceuticals S.p.A. ("Newron") (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system, today provided a clinical and business update.
  • Newron has now initiated the first clinical safety study (008)."
  • Newron intends to recruit approximately 120 patients into the study at study centers in the United States and India.
  • Newron is also developing evenamide as the potential first add-on therapy for the treatment of patients with positive symptoms of schizophrenia.

Newron Pharmaceuticals to Present at the Jefferies Virtual Healthcare Conference

Retrieved on: 
Friday, May 29, 2020
Health, Clinical trials, Research, Pharmaceutical, Science, Biotechnology, Life sciences, Articles, Biotechnology, Sodium channel blockers, Antipsychotics, Evenamide, Phenethylamines, Xetra, Xetra, Biopharmaceutical

Newron Pharmaceuticals S.p.A. (Newron) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system, today announced that Stefan Weber, CEO, will present at the upcoming Jefferies Virtual Healthcare Conference on Tuesday, June 2nd, 2020 at 9:30 a.m. EDT.

Key Points: 
  • Newron Pharmaceuticals S.p.A. (Newron) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system, today announced that Stefan Weber, CEO, will present at the upcoming Jefferies Virtual Healthcare Conference on Tuesday, June 2nd, 2020 at 9:30 a.m. EDT.
  • Newron (SIX: NWRN, XETRA: NP5) is a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system.
  • Meiji Seika has the rights to develop and commercialize the compound in Japan and other key Asian territories.
  • Newron is also developing Evenamide as the potential first add-on therapy for the treatment of patients with positive symptoms of schizophrenia.

DGAP-News: Newron AGM Result and Clinical and Business Update

Retrieved on: 
Tuesday, March 31, 2020
Sodium channel blockers, Antipsychotics, Evenamide, Phenethylamines, Schizophrenia, Caregiver, Drugs, Human behavior, Humans

Newron today also provides an update on its clinical, business and operational activities, in light of the recent COVID-19 pandemic.

Key Points: 
  • Newron today also provides an update on its clinical, business and operational activities, in light of the recent COVID-19 pandemic.
  • The health and safety of patients, caregivers and our employees is paramount and Newron has proactively taken measures in response to the COVID-19 situation to protect all stakeholders and ensure business continuity.
  • Newron will update the market with any material developments, as appropriate.
  • Newron is also developing Evenamide as the potential first add-on therapy for the treatment of patients with positive symptoms of schizophrenia.