PANSS

Newron Reports Compelling Additional Data Documenting the Efficacy of Evenamide in Pivotal Study 008A in Poorly Responding Schizophrenia Patients

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понедельник, мая 13, 2024
Mental Health, Research, FDA, Clinical Trials, Biotechnology, Other Health, Health, Pharmaceutical, Science, Patient, Weight gain, Positive, Psychosis, PANSS, Metabolic syndrome, Medication, Safety, Clozapine, Evenamide, MD, EPS, CNS, Observation, Clinical Global Impression, Schizophrenia, XETRA, Peripheral nervous system, Blood, ANCOVA, Pharmaceutical industry

Study 008A is the first well-designed study demonstrating efficacy of an adjunctive treatment in benefiting patients who do not respond to their current antipsychotic.

Key Points: 
  • Study 008A is the first well-designed study demonstrating efficacy of an adjunctive treatment in benefiting patients who do not respond to their current antipsychotic.
  • Evenamide also is the first glutamate modulator to demonstrate efficacy in inadequately responding patients with schizophrenia in a placebo-controlled study.
  • Ravi Anand, MD, Chief Medical Officer of Newron, stated: “These new efficacy results from study 008A attest to the clinical relevance of the benefits for patients, based on the primary and key secondary endpoints.
  • Most importantly, the benefits noted on the efficacy measures increased up to Day 29, thus suggesting larger and enduring effects during longer term treatment.

Royalty Pharma Reports First Quarter 2024 Results

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четверг, мая 9, 2024
FDA, Ulcerative colitis, KarXT, Food, MorphoSys, European Commission, Marketing, New Drug Application, Cystic fibrosis, PDSS, PANSS, Tourette syndrome, Lupus, Docetaxel, Roche, Schizophrenia, Novartis, ADP, Pfizer, Incidence, Bristol Myers Squibb, Patient, Neurology, Acquisition, Sacituzumab govitecan, Olanzapine, Civil service commission, Multiple sclerosis, Positive, Vertex, Sanofi, Teva Pharmaceuticals, Astellas Pharma, European Medicines Agency, Lung cancer, Pharmaceutical industry

During 2024, Royalty Pharma announced new transactions of up to $619 million.

Key Points: 
  • During 2024, Royalty Pharma announced new transactions of up to $619 million.
  • In January 2024, Royalty Pharma acquired a royalty interest in ecopipam for an upfront payment of $49 million and up to $44 million in milestone payments contingent on the achievement of certain regulatory milestones.
  • In May 2024, Royalty Pharma announced a transaction to acquire royalties and milestones on frexalimab owned by ImmuNext for approximately $525 million in cash including estimated transaction costs.
  • Royalty Pharma has provided guidance for full year 2024, excluding transactions and borrowings announced after the date of this release, as follows:

Teva and Medincell Announce Positive Phase 3 Efficacy Results from SOLARIS Trial Evaluating TEV-‘749 (olanzapine) as a Once-Monthly Subcutaneous Long-Acting Injectable in Adults with Schizophrenia

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среда, мая 8, 2024
Health, Neurology, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Schizophrenia, TEVA, Positive, Medication, PANSS, Patient, Teva Pharmaceuticals, Olanzapine

Results demonstrated that TEV-‘749 met its primary endpoint as measured by a change in the PANSS total score from baseline after 8 weeks compared to placebo.

Key Points: 
  • Results demonstrated that TEV-‘749 met its primary endpoint as measured by a change in the PANSS total score from baseline after 8 weeks compared to placebo.
  • These differences from placebo were clinically meaningful and statistically significant with adjusted P-values of
  • Currently, there is no long-acting olanzapine treatment option available for schizophrenia that does not risk post-injection delirium/sedation syndrome (PDSS).
  • Schizophrenia is often a chronic life-long disease, but by using medication consistently, people can find the treatment help they deserve.

Teva and Medincell Announce Positive Phase 3 Efficacy Results from SOLARIS Trial Evaluating TEV-‘749 (olanzapine) as a Once-Monthly Subcutaneous Long-Acting Injectable in Adults with Schizophrenia

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среда, мая 8, 2024
Mental Health, Research, Neurology, Clinical Trials, Biotechnology, Managed Care, Health, Pharmaceutical, Science, Schizophrenia, Multimedia, TEVA, Positive, Medication, PANSS, Patient, Teva Pharmaceuticals, Olanzapine

These differences from placebo were clinically meaningful and statistically significant with adjusted P-values of

Key Points: 
  • These differences from placebo were clinically meaningful and statistically significant with adjusted P-values of
  • Key secondary endpoints of CGI-S (Clinical Global Impressions – schizophrenia) and PSP (Personal and Social Performance Scale) total score were also statistically significant after adjusting for multiplicity.
  • Currently, there is no long-acting olanzapine treatment option available for schizophrenia that does not risk post-injection delirium/sedation syndrome (PDSS).
  • Additional efficacy and safety findings from the Phase 3 SOLARIS study are planned for presentation at a medical meeting later this year.

Reviva Reports Full Year 2023 Financial Results and Recent Business Highlights

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понедельник, апреля 15, 2024
Molecule, BCPP, Safety, NDA, PANSS, WCG, CNS, KOL, Schizophrenia, OLE, MPH, Central nervous system, FCCP, Pharmaceutical industry

CUPERTINO, Calif., April 15, 2024 (GLOBE NEWSWIRE) -- Reviva Pharmaceuticals Holdings, Inc. (NASDAQ: RVPH) (“Reviva” or the “Company”), a late-stage pharmaceutical company developing therapies that seek to address unmet medical needs in the areas of central nervous system (CNS), inflammatory and cardiometabolic diseases, today reported financial results for the full year ended December 31, 2023 and summarized recent business highlights.

Key Points: 
  • “2023 was an exciting and productive year for Reviva that included significant progress in the late-stage development of our brilaroxazine program for schizophrenia.
  • As of December 31, 2023, the Company’s cash and cash equivalents totaled approximately $23.4 million compared to approximately $18.5 million as of December 31, 2022.
  • The financial and related data for 2022 included in this press release, including in this “Financial Results” section and in the attached tables, is reflective of the restatement adjustments to the Company’s previously issued financial statements for the year ended December 31, 2022.
  • The financial information in this press release has been updated to reflect the effects of the restatement adjustments.

Newron Announces Positive Top-line Results From Potentially Pivotal Phase II/III Study 008A With Evenamide in Schizophrenia Patients

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вторник, апреля 30, 2024
Mental Health, Research, FDA, Clinical Trials, Biotechnology, Other Health, Health, Pharmaceutical, Science, Clinical Global Impression, Clozapine, NCE, XETRA, Safety, Psychiatry, MD, PANSS, Common, Extrapyramidal system, CNS, Schizophrenia, Vomiting, Incidence, Patient, Peripheral nervous system, Evenamide, Headache, Positive, Medication, Pharmaceutical industry

Study 008A was a four-week, international, randomized, double-blind and placebo-controlled add-on Phase II/III study performed in 45 centers in 11 countries in Europe, Asia and Latin America.

Key Points: 
  • Study 008A was a four-week, international, randomized, double-blind and placebo-controlled add-on Phase II/III study performed in 45 centers in 11 countries in Europe, Asia and Latin America.
  • 291 patients were randomized to treatment either with evenamide or placebo as add-on to their current antipsychotic therapy.
  • Two hundred and eighty of the 291 patients completed the study with only three patients discontinuing the study due to adverse events, two of them on evenamide and one patient on placebo who died during the study.
  • Ravi Anand, MD, Chief Medical Officer of Newron, stated: “The results seen in study 008A with evenamide are ground-breaking and unique from many perspectives.

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

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среда, апреля 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.

Anavex Life Sciences Initiates Placebo-Controlled U.S. Phase 2 Clinical Trial of ANAVEX®3-71 in Schizophrenia

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понедельник, марта 18, 2024
EEG, U.S. FDA, Schizophrenia, Deficit spending, Data analysis, Memory, Alzheimer's disease, Central nervous system, Part, Delusion, Patient, CNS, ERP, Biomarker, Doctor of Philosophy, Parkinson's disease, Quality of life, Personalized medicine, Life, Trial of the century, Positive, Rett syndrome, Hallucination, PANSS, Therapy, SIGMAR1, DSM-IV codes, FDA, Pharmaceutical industry

NEW YORK, March 18, 2024 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative, neurodevelopmental, and psychiatric disorders, including Alzheimer's disease, Parkinson's disease, Rett syndrome, schizophrenia, and other central nervous system (CNS) diseases, today announced that the first patient in its U.S. FDA cleared placebo-controlled Phase 2 clinical study of ANAVEX®3-71 for the treatment of schizophrenia has been screened ahead of schedule.

Key Points: 
  • “Initiating our Phase 2 trial of ANAVEX®3-71 in schizophrenia ahead of schedule is a testament to the hard work and dedication of our clinical study team,” stated Christopher U Missling, PhD, President and Chief Executive Officer of Anavex.
  • “Schizophrenia is a challenging disorder that can impair social and occupational functions and overall quality of life for the nearly 24 million people affected worldwide.
  • The placebo-controlled Phase 2, two-part, in-patient trial, ANAVEX®3-71-SZ-001 ( NCT06245213 ), will investigate the effects of ANAVEX®3-71 in patients with schizophrenia.
  • In addition to the electrophysiological biomarkers, Anavex is applying novel neuroinflammatory, metabolomic, and transcriptomic biomarkers at the intersection of schizophrenia pathophysiology and ANAVEX®3-71’s novel, dual mechanism of action.

Bristol Myers Squibb Presents New Interim Long-Term Efficacy Data from the EMERGENT-4 Trial Evaluating KarXT in Schizophrenia at the 2024 Annual Congress of the Schizophrenia International Research Society

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суббота, апреля 6, 2024
Biotechnology, Pharmaceutical, Health, Mental Health, BMY, Circulatory system, Head, SIRS, Schizophrenia, Xanomeline, Assessment, Patient, Bristol Myers Squibb, MD, Positive, Efficacy, Congress, Prolactin, Clinical trial, Safety, PANSS, FDA, Schizophrenia International Research Society, Pharmaceutical industry

Bristol Myers Squibb (NYSE: BMY) today announced new interim results from the Phase 3 EMERGENT-4 open-label extension trial evaluating the long-term efficacy, safety and tolerability of KarXT (xanomeline-trospium) in adults with schizophrenia.

Key Points: 
  • Bristol Myers Squibb (NYSE: BMY) today announced new interim results from the Phase 3 EMERGENT-4 open-label extension trial evaluating the long-term efficacy, safety and tolerability of KarXT (xanomeline-trospium) in adults with schizophrenia.
  • Long-term efficacy data from the trial were presented in a poster titled, “Maintenance of Efficacy of KarXT (Xanomeline and Trospium) in Schizophrenia” (Poster F264) at the Annual Congress of the Schizophrenia International Research Society (SIRS) being held April 3-7, 2024, in Florence, Italy.
  • In the interim analysis, KarXT was associated with significant improvement in symptoms of schizophrenia across all efficacy measures at 52 weeks.
  • In long-term trials, KarXT was generally well tolerated, with a side effect profile consistent with prior trials of KarXT in schizophrenia.

Newron Presents 2023 Financial Results and Provides 2024 Outlook

Retrieved on: 
вторник, марта 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.