Clozapine

EQS-News: Newron presents 2023 financial results and provides 2024 outlook

Retrieved on: 
Wednesday, April 10, 2024
Psychosis, Schizophrenia, Clozapine, XETRA, Patient, CNS, Business development, Peripheral nervous system, Psychedelic literature, Safety, TRS, PANSS, EIB, Canadian International Council, Pharmaceutical industry

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 financial results and operational highlights for the business year ended December 31, 2023, and provided an outlook for 2024.

Key Points: 
  • 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 financial results and operational highlights for the business year ended December 31, 2023, and provided an outlook for 2024.
  • Results from the first 100 patients to complete six months (30 weeks) of treatment with evenamide were reported in January, followed by results in February 2023 from the same 100-person cohort at the one-year (52 weeks) timepoint.
  • These data were further strengthened, post-period in January 2024, with the final results from study 015 reviewing all study participants after one year of treatment.
  • Patient enrollment has completed and results from this study are expected in April 2024.

EQS-News: 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)

Retrieved on: 
Wednesday, April 10, 2024
SIRS, Schizophrenia, Clozapine, XETRA, Incidence, Patient, CNS, Peripheral nervous system, Safety, TRS, Schizophrenia International Research Society, Pharmaceutical industry

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.

Key Points: 
  • 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.
  • As previously announced by Newron, the study showed that the addition of evenamide to antipsychotics was well tolerated, with low incidence of treatment-emergent adverse events.
  • Treatment with evenamide was associated with sustained, clinically significant benefit that increased throughout the one-year course of treatment.
  • Study 008A is a four-week, randomized, double-blind and placebo-controlled study assessing the efficacy, tolerability, and safety of evenamide (30 mg bid).

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)

Retrieved on: 
Monday, April 8, 2024
Mental Health, Research, Neurology, Biotechnology, Health, Pharmaceutical, General Health, Other Science, Science, SIRS, Schizophrenia, Medication, Clozapine, XETRA, Incidence, Patient, CNS, Peripheral nervous system, Safety, TRS, Schizophrenia International Research Society, Pharmaceutical industry

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.

Key Points: 
  • 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.
  • As previously announced by Newron, the study showed that the addition of evenamide to antipsychotics was well tolerated, with low incidence of treatment-emergent adverse events.
  • Treatment with evenamide was associated with sustained, clinically significant benefit that increased throughout the one-year course of treatment.
  • Study 008A is a four-week, randomized, double-blind and placebo-controlled study assessing the efficacy, tolerability, and safety of evenamide (30 mg bid).

Newron Presents 2023 Financial Results and Provides 2024 Outlook

Retrieved on: 
Tuesday, March 19, 2024
Mental Health, Research, Neurology, Biotechnology, Health, Pharmaceutical, General Health, Other Science, Science, Psychosis, Schizophrenia, Medication, Clozapine, XETRA, Patient, CNS, Business development, Peripheral nervous system, Psychedelic literature, Safety, TRS, PANSS, EIB, Canadian International Council, Pharmaceutical industry

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.

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 business year ended December 31, 2023, and provided an outlook for 2024.
  • Results from the first 100 patients to complete six months (30 weeks) of treatment with evenamide were reported in January, followed by results in February 2023 from the same 100-person cohort at the one-year (52 weeks) timepoint.
  • These data were further strengthened, post-period in January 2024, with the final results from study 015 reviewing all study participants after one year of treatment.
  • Patient enrollment has completed and results from this study are expected in April 2024.

Solace Behavioral Health Selects Core Solutions' Cx360 HER

Retrieved on: 
Tuesday, March 12, 2024
Health, Documentation, Growth, Schizophrenia, Clozapine, MIPS, LCSW, Transcranial magnetic stimulation, TMS, Mental health, Consolation, MD, Senior counsel, Ketamine, EHR, Core

KING OF PRUSSIA, Pa., March 12, 2024 /PRNewswire/ -- Core Solutions, Inc., (Core) is pleased to announce that Solace Behavioral Health has selected its Cx360 behavioral health electronic health record (EHR) solution. This selection reflects the organization's ongoing commitment to incorporating cutting-edge solutions that strengthen access to mental health and substance use care and deliver positive outcomes.

Key Points: 
  • KING OF PRUSSIA, Pa., March 12, 2024 /PRNewswire/ -- Core Solutions, Inc., (Core) is pleased to announce that Solace Behavioral Health has selected its Cx360 behavioral health electronic health record (EHR) solution.
  • Solace is one of the largest behavioral health providers in Florida, offering a wide range of therapies and techniques at its four locations.
  • In addition to traditional behavioral health services, such as psychiatric evaluation, counseling, addiction treatment, intensive outpatient, and detox, Solace offers solutions that help distinguish the organization from other providers.
  • Core Solutions and its Cx360 EHR will further enable our team to leverage targeted interventions that empower clients on their journey to improved health."

Keystone Lab Announces Addition of Tianeptine to Testing Menu

Retrieved on: 
Tuesday, February 13, 2024
Clozapine, Anxiety, Opioid use disorder, Modafinil, Diphenhydramine, FDA, Pain, MC5, Aripiprazole, Food and Drug Administration, Forensic toxicology, Loperamide, Death, Keystone, Neptune, Abdominal pain, Patient, CLIA, Urine, Tianeptine, Depression

ASHEVILLE, N.C., Feb. 13, 2024 /PRNewswire/ -- Keystone Lab , a dual-CAP accredited and CLIA certified lab based in Asheville, NC, has officially added tianeptine to its in-house urine clinical toxicology menu.

Key Points: 
  • ASHEVILLE, N.C., Feb. 13, 2024 /PRNewswire/ -- Keystone Lab , a dual-CAP accredited and CLIA certified lab based in Asheville, NC, has officially added tianeptine to its in-house urine clinical toxicology menu.
  • Keystone provides clinical and forensic toxicology testing services throughout the southeastern U.S. and is one of few labs in the southeast to offer testing for tianeptine.
  • In addition to tianeptine and its metabolite, tianeptine metabolite MC5, Keystone has also added clozapine, N-desmethylclozapine, aripiprazole, aripiprazole metabolite OPC-3373, modafinil, diphenhydramine, loperamide, and 7OH-mitragynine to its in-house menu.
  • "By adding tianeptine testing in-house, Keystone is able to listen to its clients and provide the best service possible to their patients."

Research Team at UNC Validates PixCell Medical's HemoScreen as Game-Changer for Clozapine Monitoring in Psychiatry

Retrieved on: 
Wednesday, November 29, 2023
Research, Safety, POC, Psychiatry, Risk, Patient, FDA, ANC, CBC, University, UNC, Health care, Agranulocytosis, Medical device, Clozapine

The research, which evaluated three point-of-care instruments for complete blood count analysis, has positioned HemoScreen as the optimal solution for the management of Clozapine treatment.

Key Points: 
  • The research, which evaluated three point-of-care instruments for complete blood count analysis, has positioned HemoScreen as the optimal solution for the management of Clozapine treatment.
  • Dr. Yaara Ben Yosef, PixCell Medical's director of clinical affairs, emphasized; "This research demonstrates that HemoScreen is the superior choice for monitoring patients on Clozapine therapy.
  • This groundbreaking research cements PixCell Medical's HemoScreen as the gold standard for complete blood count analysis in Clozapine therapy.
  • Healthcare providers can confidently rely on HemoScreen to ensure the safety and efficacy of Clozapine treatment for patients with treatment-resistant schizophrenia.

Gedeon Richter: A new hope for treatment-resistant schizophrenia?

Retrieved on: 
Thursday, October 5, 2023
Scott Richter, Congress, Safety, Cariprazine, Clozapine, World Psychiatric Association, TRS, Gedeon Richter (company), Gedeon Richter, Patient, Pharmaceutical industry, Schizophrenia, Psychiatry

Schizophrenia is a chronic psychiatric disorder characterized by positive, negative, cognitive, and mood symptoms, affecting 1% of the population.

Key Points: 
  • Schizophrenia is a chronic psychiatric disorder characterized by positive, negative, cognitive, and mood symptoms, affecting 1% of the population.
  • Although antipsychotics are effective in the treatment of positive symptoms, the management of negative, cognitive, and affective symptoms often remains challenging.
  • Cariprazine is a 3rd generation antipsychotic medication with a unique receptor profile and proven efficacy in persistent negative symptoms.
  • At the Gedeon Richter and Recordati supported Meet-the-Expert session, Professor Christoph U. Correll talked about the activating-sedating effects of antipsychotics with special focus on cariprazine.

Newron to Present Three Posters on Its Clinical Program Evaluating Evenamide in the Treatment of Schizophrenia at the 36th European College of Neuropsychopharmacology Congress

Retrieved on: 
Wednesday, October 4, 2023
Health, Neurology, Other Science, General Health, Science, Pharmaceutical, Biotechnology, CINP, Schizophrenia, TRS, XETRA, Clozapine, Medication, Congress, European College of Neuropsychopharmacology, Patient, ECNP, SIRS, Peripheral nervous system, Pharmaceutical industry, Newron Cup

Full results from all 161 patients who were randomized in study 014 and who completed six months of participation in study 015 will be presented.

Key Points: 
  • Full results from all 161 patients who were randomized in study 014 and who completed six months of participation in study 015 will be presented.
  • Study 015 is an international, randomized, open-label, rater-blinded, phase II extension study of evenamide as an add-on therapy to an antipsychotic (excluding clozapine) in patients with moderate to severe TRS, not responding to their current antipsychotic medication.
  • Newron presented the data from all 161 patients at the six-week time point and data from the first 100 patients randomized in study 014 who completed one-year of participation in these studies at the 34th CINP World Congress of Neuropsychopharmacology and at the 2023 SIRS Annual Congress in May 2023.
  • The design of a potentially pivotal, international, randomized, double-blind, placebo-controlled, Phase III study aims to demonstrate the efficacy and tolerability of two doses (15 and 30 mg bid) of evenamide as an add-on treatment in TRS patients not benefiting from their current antipsychotic treatment will also be presented at the ECNP.

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: