Evenamide

EQS-News: Newron TRS study 6 months’ results: Evenamide substantially improves patients to an extent that they no longer meet protocol entry criteria

Retrieved on: 
Tuesday, October 17, 2023
Incidence, Schizophrenia, LOF, Clinical Global Impression, PANSS, Safety, CEST, Positive, Evenamide, TRS, Strauss, CNS, Peripheral nervous system, Psychosis, Level, XETRA, ECNP, Patient, Pharmaceutical industry, Nursing, Functional neurologic disorder

Newron TRS study 6 months’ results: Evenamide substantially improves patients to an extent that they no longer meet protocol entry criteria

Key Points: 
  • Newron TRS study 6 months’ results: Evenamide substantially improves patients to an extent that they no longer meet protocol entry criteria
    The issuer is solely responsible for the content of this announcement.
  • 95% of patients completed six weeks of treatment, 94% of the completers chose to continue with evenamide treatment into the long-term extension study (Study 015) and 92% of them reached six months of treatment.
  • In contrast to common clinical experience, no patients experienced worsening of their psychoses; consequently, no patients relapsed.
  • Review of the efficacy data indicated that treatment with evenamide resulted in approximately 40% of patients, at six months, no longer meeting the protocol severity criteria used to diagnose treatment resistance.

Newron Announces H1 2023 Results and Provides R&D Update

Retrieved on: 
Friday, August 4, 2023
Science, Neurology, Other Science, Biotechnology, Research, Pharmaceutical, General Health, Health, Business development, US Foods, Partnership, Psychosis, Schizophrenia, TRS, Paragraph, XETRA, AGM, Don, Evenamide, The International Journal of Neuropsychopharmacology, CNS, Movement, Clozapine, Medication, Tablet, Sale, Congress, Incidence, European College of Neuropsychopharmacology, Orange Book, Patient, Canadian International Council, NCE, ECNP, Abbreviated New Drug Application, Phase, FDA, Food, Safety, Peripheral nervous system, Pharmaceutical industry, Medical imaging, Management, Newron Cup

We have reported three striking sets of data from our evenamide development program for treatment-resistant schizophrenia (TRS), presented these results at international psychiatry scientific conferences, and published key results in a peer-reviewed journal.

Key Points: 
  • We have reported three striking sets of data from our evenamide development program for treatment-resistant schizophrenia (TRS), presented these results at international psychiatry scientific conferences, and published key results in a peer-reviewed journal.
  • The exciting results triggered substantial interest from potential partners on future collaboration opportunities for the development of evenamide.”
    In Q1 2023, Newron announced three exciting new sets of data evaluating evenamide as an add-on treatment for patients with TRS.
  • Study 008A is continuing to enroll patients in this indication, and results are expected by end of 2023/early in 2024.
  • Financial Summary (IFRS) H1 2023 and H1 2022:

EQS-News: Newron announces H1 2023 results and provides R&D update

Retrieved on: 
Friday, August 4, 2023
Business development, US Foods, Partnership, Psychosis, CET, Schizophrenia, TRS, Paragraph, XETRA, AGM, Don, Evenamide, The International Journal of Neuropsychopharmacology, CNS, Movement, Clozapine, Sale, Tablet, Congress, Incidence, European College of Neuropsychopharmacology, Orange Book, Patient, Canadian International Council, NCE, ECNP, Abbreviated New Drug Application, Phase, FDA, Food, Safety, Peripheral nervous system, Pharmaceutical industry, Medical imaging, Management, Newron Cup

We have reported three striking sets of data from our evenamide development program for treatment-resistant schizophrenia (TRS), presented these results at international psychiatry scientific conferences, and published key results in a peer-reviewed journal.

Key Points: 
  • We have reported three striking sets of data from our evenamide development program for treatment-resistant schizophrenia (TRS), presented these results at international psychiatry scientific conferences, and published key results in a peer-reviewed journal.
  • Study 008A is continuing to enroll patients in this indication, and results are expected by end of 2023/early in 2024.
  • The results seen validate the rule of glutamate release inhibition in repairing disturbed neural connectivity in the TRS population.
  • Financial Summary (IFRS) H1 2023 and H1 2022:

EQS-News: Newron announces striking six-month interim results from its exploratory clinical trial evaluating evenamide as add-on therapy for patients with treatment-resistant schizophrenia

Retrieved on: 
Sunday, January 22, 2023
Neuroscience, Peripheral nervous system, CET, Clozapine, Newron Cup, Semel Institute for Neuroscience and Human Behavior, Education, Evenamide, Clinical Global Impression, CNS, Patient, Safety, XETRA, UCLA, Congress, PANSS, TRS, Positive, European, Pharmaceutical industry, Psychiatry

85 of the 100 patients completed the 30-week treatment period with evenamide.

Key Points: 
  • 85 of the 100 patients completed the 30-week treatment period with evenamide.
  • The proportion of patients demonstrating a clinically meaningful PANSS improvement (“responders”) at week 30 more than doubled from 16.5% at week six.
  • The addition of evenamide to the current antipsychotic medication of the patients continued to be well tolerated after six months of treatment.
  • Evenamide was well tolerated with few adverse effects and 85 of 100 patients remained on treatment at 30 weeks.

Newron announces striking six-month interim results from its exploratory clinical trial evaluating evenamide as add-on therapy for patients with treatment-resistant schizophrenia

Retrieved on: 
Tuesday, January 3, 2023
Mental Health, Research, Clinical Trials, Biotechnology, Other Health, Health, Pharmaceutical, Other Science, Science, Neuroscience, Peripheral nervous system, CET, Clozapine, Semel Institute for Neuroscience and Human Behavior, Education, Evenamide, Clinical Global Impression, CNS, Medication, Patient, Safety, XETRA, UCLA, Congress, PANSS, TRS, Positive, European, Pharmaceutical industry, Newron Cup, Psychiatry

85 of the 100 patients completed the 30-week treatment period with evenamide.

Key Points: 
  • 85 of the 100 patients completed the 30-week treatment period with evenamide.
  • The proportion of patients demonstrating a clinically meaningful PANSS improvement (“responders”) at week 30 more than doubled from 16.5% at week six.
  • The addition of evenamide to the current antipsychotic medication of the patients continued to be well tolerated after six months of treatment.
  • Evenamide was well tolerated with few adverse effects and 85 of 100 patients remained on treatment at 30 weeks.

Newron provides H1 2022 results and updates on R&D and business activities

Retrieved on: 
Thursday, September 15, 2022
Health, Genetics, General Health, Research, Science, Pharmaceutical, Biotechnology, Safety, Abbreviated New Drug Application, Tablet, Chief information officer, Social Security Government Pension Offset, ESG, Schizophrenia, Director, FDA, Food, Phase, Company, Partnership, Psychosis, Patient, XETRA, Senior management, Orange Book, QI, Levodopa-induced dyskinesia, Annual report, Medication, Congress, Evenamide, Positive, Â, TRS, CINP, US Foods, PANSS, Paragraph, Board, LOF, PD, Peripheral nervous system, Social, Pharmaceutical industry, Cryptocurrency, Lithium, Management, New chemical entity, Operation, Biophysical environment, Newron Cup

We also strengthened our senior leadership team and furthered our commitments to ESG standards, principles and outcomes.

Key Points: 
  • We also strengthened our senior leadership team and furthered our commitments to ESG standards, principles and outcomes.
  • In June 2022, Newron presented key scientific data of evenamide at the 33rd Collegium Internationale Neuro-Psychopharmacologicum (CINP) Hybrid World Congress of Neuropsychopharmacology, in Taipei, Taiwan.
  • Newron sees significant progress in the enrolment of patients for study 014 and expects to complete the process by the end of 2022, with results from the study due in QI/2023.
  • Filippo joined Newron in November 2016 as IT Director and became Director of Operations in January 2022.

DGAP-News: Newron provides H1 2022 results and updates on R&D and business activities

Retrieved on: 
Thursday, September 15, 2022
Safety, Abbreviated New Drug Application, Tablet, Chief information officer, Social Security Government Pension Offset, ESG, Schizophrenia, Director, FDA, Food, Phase, Company, Partnership, Psychosis, Patient, XETRA, Senior management, Orange Book, QI, Levodopa-induced dyskinesia, Annual report, Congress, CET, Evenamide, Positive, Â, TRS, CINP, US Foods, PANSS, Paragraph, Board, LOF, PD, Peripheral nervous system, Social, Cryptocurrency, Pharmaceutical industry, Lithium, Management, New chemical entity, Operation, Biophysical environment, Newron Cup

We also strengthened our senior leadership team and furthered our commitments to ESG standards, principles and outcomes.

Key Points: 
  • We also strengthened our senior leadership team and furthered our commitments to ESG standards, principles and outcomes.
  • In June 2022, Newron presented key scientific data of evenamide at the 33rd Collegium Internationale Neuro-Psychopharmacologicum (CINP) Hybrid World Congress of Neuropsychopharmacology, in Taipei, Taiwan.
  • Newron sees significant progress in the enrolment of patients for study 014 and expects to complete the process by the end of 2022, with results from the study due in QI/2023.
  • Filippo joined Newron in November 2016 as IT Director and became Director of Operations in January 2022.

Newron Announces 2021 Financial Results and Provides Outlook for 2022

Retrieved on: 
Tuesday, March 15, 2022
Mental Health, Health, Other Science, Clinical Trials, Science, Pharmaceutical, Biotechnology, TRS, Patient, Schizophrenia, IFRS, Partnership, EEG, Abbreviated New Drug Application, FDA, Anders (singer), XETRA, BID, EIB, Levodopa-induced dyskinesia, Risk, PD, Evenamide, Paragraph, Medication, Safety, Tablet, Central nervous system, European Investment Bank, EUR, Sale, Orange Book, Food, Psychosis, Peripheral nervous system, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Pharmaceutical industry, Generic drug, Film, Newron Cup

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 its financial results and operational highlights for the year ended December 31, 2021, and provided an outlook for 2022.

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 its financial results and operational highlights for the year ended December 31, 2021, and provided an outlook for 2022.
  • In 2021, Newron announced the results from two short-term explanatory studies of evenamide, study 010 and study 008, which both met their primary objective of safety.
  • Study 008A involves treatment centers across twelve countries in Europe, Asia and Latin America, and results are expected around the end of 2022.
  • Cash and Other current financial assets as at December 31, 2021 were at EUR 34.6 million, compared to EUR 31.3 million at the beginning of the year
    Financial Summary (IFRS) 2021 and 2020:

DGAP-News: Newron announces 2021 financial results and provides outlook for 2022

Retrieved on: 
Tuesday, March 15, 2022
TRS, Patient, Schizophrenia, IFRS, Partnership, EEG, Abbreviated New Drug Application, FDA, Anders (singer), XETRA, BID, EIB, Levodopa-induced dyskinesia, Risk, PD, Evenamide, Paragraph, Safety, CET, Tablet, Central nervous system, Parkinson's disease, European Investment Bank, EUR, Sale, Orange Book, Food, Psychosis, Peripheral nervous system, Plasma protein binding, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Pharmaceutical industry, Film, Newron Cup

Milan, Italy, March 15, 2022, 7 am CET - 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 its financial results and operational highlights for the year ended December 31, 2021, and provided an outlook for 2022.

Key Points: 
  • Milan, Italy, March 15, 2022, 7 am CET - 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 its financial results and operational highlights for the year ended December 31, 2021, and provided an outlook for 2022.
  • In 2021, Newron announced the results from two short-term explanatory studies of evenamide, study 010 and study 008, which both met their primary objective of safety.
  • Study 008A involves treatment centers across twelve countries in Europe, Asia and Latin America, and results are expected around the end of 2022.
  • Cash and Other current financial assets as at December 31, 2021 were at EUR 34.6 million, compared to EUR 31.3 million at the beginning of the year
    Financial Summary (IFRS) 2021 and 2020:

DGAP-News: Change in Newron Board of Directors

Retrieved on: 
Wednesday, December 1, 2021
Patient, CEO, United Arab Emirates, Evenamide, European Union, Company, News, Board of directors, Parkinson, DGAP, XETRA, Schizophrenia, Peripheral nervous system, Board, Director, Parkinson's disease, Intention, Security (finance), Pharmaceutical industry, Management

Milan, Italy - Dec. 1, 2021 - 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 Robert Leslie Holland has informed the Board of Directors of his intention to step down as a Non-Executive member of the Board of Directors, effective December 31, 2021.

Key Points: 
  • Milan, Italy - Dec. 1, 2021 - 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 Robert Leslie Holland has informed the Board of Directors of his intention to step down as a Non-Executive member of the Board of Directors, effective December 31, 2021.
  • Ulrich Kstlin, Chairman of Newron, commented: "The Board of Directors and I would like to thank Bob for his dedication and commitment to Newron since he joined the Board in 2013.
  • At this time, Newron does not anticipate making any Non-Executive Director appointments.
  • Newron is developing evenamide as the potential first add-on therapy for the treatment of patients with positive symptoms of schizophrenia.