reports
- Sean Conroy
Newron Pharmaceuticals - Evenamide notches up another win (study 008A)
Newron Pharmaceuticals has shared positive top-line data for its evenamide programme from its potentially pivotal Phase II/III trial (study 008A) in patients with poorly managed schizophrenia on current antipsychotic therapy, but not considered treatment-resistant. The trial met its primary endpoint of improvement on the Positive and Negative Syndrome Scale (PANSS) score from baseline, and the key secondary endpoint of improvement on the Clinical Global Impression of Severity (CGI-S) scale. Stat...
Newron Announces Positive Top-line Results From Potentially Pivotal Ph...
MILAN--(BUSINESS WIRE)-- 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 (CNS), today announced positive top-line results from its potentially pivotal study 008A, evaluating the safety, tolerability and efficacy of evenamide (30 mg bid) in patients with chronic schizophrenia currently being treated with a second-generation antipsychotic including clozapine, but demonstrating an inadequate response to that treatment. The study met it...
EQS-News: Newron announces positive top-line results from potentially...
EQS-News: Newron Pharmaceuticals S.p.A. / Key word(s): Study results Newron announces positive top-line results from potentially pivotal Phase II/III study 008A with evenamide in schizophrenia patients 30.04.2024 / 07:00 CET/CEST The issuer is solely responsible for the content of this announcement. Newron announces positive top-line results from potentially pivotal Phase II/III study 008A with evenamide in schizophrenia patients Primary endpoint and key secondary endpoint of study met; drug was well tolerated, with no safety concerns identified Glutamatergic inhibiti...
EQS-News: Newron: Positive Topline-Ergebnisse der potenziell zulassung...
EQS-News: Newron Pharmaceuticals S.p.A. / Schlagwort(e): Studienergebnisse Newron: Positive Topline-Ergebnisse der potenziell zulassungsrelevanten Phase II/III-Studie 008A mit Evenamide in Schizophrenie-Patienten 30.04.2024 / 07:00 CET/CEST Für den Inhalt der Mitteilung ist der Emittent / Herausgeber verantwortlich. Newron: Positive Topline-Ergebnisse der potenziell zulassungsrelevanten Phase II/III-Studie 008A mit Evenamide in Schizophrenie-Patienten Primärer Endpunkt und zentraler sekundärer Endpunkt der Studie erreicht; Medikament wurde gut vertragen; keine Sicherheit...
Data from Newron’s study 014/015 and an evenamide clinical development...
MILAN--(BUSINESS WIRE)-- 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 (CNS), presented four posters and two oral presentations at the 2024 Annual Congress of the Schizophrenia International Research Society (SIRS) from 3-7 April in Florence, Italy. The data presented were detailing previously reported scientific results of study 014/015, the future clinical development outlook for evenamide and information on study 008A. Study ...
EQS-News: Data from Newron’s study 014/015 and an evenamide clinical d...
EQS-News: Newron Pharmaceuticals S.p.A. / Key word(s): Study results Data from Newron’s study 014/015 and an evenamide clinical development outlook presented at the 2024 Annual Congress of the Schizophrenia International Research Society (SIRS) 08.04.2024 / 07:00 CET/CEST The issuer is solely responsible for the content of this announcement. Data from Newron’s study 014/015 and an evenamide clinical development outlook presented at the 2024 Annual Congress of the Schizophrenia International Research Society (SIRS) Data from study 014/015, a phase II trial evaluating e...
EQS-News: Newron präsentiert Daten der Studie 014/015 und Pläne für we...
EQS-News: Newron Pharmaceuticals S.p.A. / Schlagwort(e): Studienergebnisse Newron präsentiert Daten der Studie 014/015 und Pläne für weitere klinische Entwicklung von Evenamide auf dem Jahreskongress 2024 der Schizophrenia International Research Society (SIRS) 08.04.2024 / 07:00 CET/CEST Für den Inhalt der Mitteilung ist der Emittent / Herausgeber verantwortlich. Newron präsentiert Daten der Studie 014/015 und Pläne für weitere klinische Entwicklung von Evenamide auf dem Jahreskongress 2024 der Schizophrenia International Research Society (SIRS) Daten der Studie 014/015,...
- Sean Conroy
Newron Pharmaceuticals - Evenamide set for a pivotal year
Newron Pharmaceuticals has reported results for FY23, an active period for its lead asset, evenamide, being developed for treatment-resistant schizophrenia (TRS) and poorly managed schizophrenia (non-TRS). Strong 12-month data were shared in January 2024 from the Phase II trial (study 014/015) in TRS patients, and management is gearing up to launch a potentially pivotal Phase III trial. We expect the next major catalyst to be results of the Phase III trial (study 008A) in non-TRS patients, now a...
Newron Presents 2023 Financial Results and Provides 2024 Outlook
MILAN--(BUSINESS WIRE)-- 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 business year ended December 31, 2023, and provided an outlook for 2024. Highlights 2023: Evenamide (Schizophrenia) Compelling efficacy results across multiple investigation timepoints up to and including one-year from study 014/015 evaluating evenamide as an add-on therapy to a si...
EQS-News: Newron gibt Geschäftsergebnisse 2023 und Ausblick 2024 bekan...
EQS-News: Newron Pharmaceuticals S.p.A. / Schlagwort(e): Jahresbericht Newron gibt Geschäftsergebnisse 2023 und Ausblick 2024 bekannt 19.03.2024 / 07:00 CET/CEST Für den Inhalt der Mitteilung ist der Emittent / Herausgeber verantwortlich. Newron gibt Geschäftsergebnisse 2023 und Ausblick 2024 bekannt Mailand, Italien – 19. März 2024, 07:00 MEZ – Newron Pharmaceuticals S.p.A. („Newron”, SIX: NWRN, XETRA: NP5), ein biopharmazeutisches Unternehmen, das sich auf die Entwicklung neuartiger Therapien für Patienten mit Erkrankungen des zentralen und peripheren Nervensystems ko...
EQS-News: Newron presents 2023 financial results and provides 2024 out...
EQS-News: Newron Pharmaceuticals S.p.A. / Key word(s): Annual Report Newron presents 2023 financial results and provides 2024 outlook 19.03.2024 / 07:00 CET/CEST The issuer is solely responsible for the content of this announcement. Newron presents 2023 financial results and provides 2024 outlook Milan, Italy, March 19, 2024, 07:00 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 f...
- Sean Conroy
Newron Pharmaceuticals - Operational flexibility with new/updated fina...
Newron Pharmaceuticals has announced new arrangements that offer the company improved operational flexibility. We estimate a pro forma gross cash balance of €17.5m (estimated year-end gross cash of €12m plus €5.5m initial equity issue) to extend the company’s cash runway into FY25, well past the top-line readout from the potentially pivotal 008A study (expected this month) and initiation of the Phase III 003 study (anticipated in Q224), both assessing evanamide in schizophrenia subsets. Provided...
Newron announces agreement with the European Investment Bank (EIB) to ...
MILAN--(BUSINESS WIRE)-- 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 (CNS), today reports agreement with the European Investment Bank (EIB) on an amendment to certain terms of its 2018 financing agreement. Under the amendment, repayment of tranches one to three (out of a total of five) of the financing agreement with due dates from June 2024 to April 2025 will be shifted substantially, with tranche one now scheduled for Novemb...
EQS-News: Newron announces agreement with the European Investment Bank...
EQS-News: Newron Pharmaceuticals S.p.A. / Key word(s): Financing Newron announces agreement with the European Investment Bank (EIB) to extend the near-term tranche repayment dates of its 2018 financing agreement 15.03.2024 / 07:00 CET/CEST The issuer is solely responsible for the content of this announcement. Newron announces agreement with the European Investment Bank (EIB) to extend the near-term tranche repayment dates of its 2018 financing agreement EIB agrees to extend repayment dates of tranches one to three of its loan to the Company until end of 2025 and into 2...
EQS-News: Newron gibt Vereinbarung mit der Europäischen Investitionsba...
EQS-News: Newron Pharmaceuticals S.p.A. / Schlagwort(e): Finanzierung Newron gibt Vereinbarung mit der Europäischen Investitionsbank (EIB) über die Verschiebung der Rückzahlungstermine der anstehenden Tranchen seiner Finanzierungsvereinbarung von 2018 bekannt 15.03.2024 / 07:00 CET/CEST Für den Inhalt der Mitteilung ist der Emittent / Herausgeber verantwortlich. Newron gibt Vereinbarung mit der Europäischen Investitionsbank (EIB) über die Verschiebung der Rückzahlungstermine der anstehenden Tranchen seiner Finanzierungsvereinbarung von 2018 bekannt EIB verlängert die Rüc...
EQS-News: Newron enters into an agreement for the subscription of up ...
EQS-News: Newron Pharmaceuticals S.p.A. / Key word(s): Financing Newron enters into an agreement for the subscription of up to 2.05 million newly issued shares; Proceeds of up to EUR 15.0 million 14.03.2024 / 18:32 CET/CEST The issuer is solely responsible for the content of this announcement. Newron enters into an agreement for the subscription of up to 2.05 million newly issued shares Proceeds of up to EUR 15.0* million Milan, Italy, March 14, 2024, 17:45 CET – Newron Pharmaceuticals S.p.A. (“Newron”, or the “Company”) (SIX: NWRN, XETRA: NP5), a biopharmaceutica...
EQS-News: Newron: Zeichnungsvereinbarung über bis zu 2,05 Millionen ne...
EQS-News: Newron Pharmaceuticals S.p.A. / Schlagwort(e): Finanzierung Newron: Zeichnungsvereinbarung über bis zu 2,05 Millionen neu ausgegebene Aktien; Erlös von bis zu EUR 15,0 Mio. 14.03.2024 / 18:32 CET/CEST Für den Inhalt der Mitteilung ist der Emittent / Herausgeber verantwortlich. Newron: Zeichnungsvereinbarung über bis zu 2,05 Millionen neu ausgegebene Aktien Erlös von bis zu EUR 15,0* Mio. Mailand, Italien, 14. März 2024, 17:45 CET – Newron Pharmaceuticals S.p.A. („Newron“, oder das „Unternehmen“) (SIX: NWRN, XETRA: NP5), ein biopharmazeutisches Unternehmen, das...
- Sean Conroy
Newron Pharmaceuticals - TRS data green-lights evenamide Phase III pla...
Newron has announced positive 12-month data from its Phase II extension trial (study 015) assessing evenamide in 161 patients with treatment-resistant schizophrenia (TRS). The results demonstrate desirable safety and tolerability, as well as durable efficacy of evenamide, showing statistically significant improvements (p-value
Newron Reports Exceptional One-year Results of Study 014/15 With Evena...
MILAN--(BUSINESS WIRE)-- 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 (CNS), today reported positive final, one-year results from its open label study 014/015, evaluating its investigational drug evenamide as an add-on to antipsychotics for the management of treatment-resistant schizophrenia (TRS). The data demonstrated that treatment with evenamide was associated with sustained clinically significant benefit that increased throu...
EQS-News: Newron reports exceptional one-year results of study 014/15 ...
EQS-News: Newron Pharmaceuticals S.p.A. / Key word(s): Study results Newron reports exceptional one-year results of study 014/15 with evenamide in treatment-resistant schizophrenia (TRS) 04.01.2024 / 07:00 CET/CEST The issuer is solely responsible for the content of this announcement. Newron reports exceptional one-year results of study 014/15 with evenamide in treatment-resistant schizophrenia (TRS) Treatment with evenamide demonstrated significant, clinically important, progressive, sustained and long-lasting improvement on PANSS total, CGI-S and Level of Functioning...
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