Positive

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

Retrieved on: 
Monday, March 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.

BioXcel Therapeutics Reports Financial Results for the Fourth Quarter and Full Year 2023

Retrieved on: 
Tuesday, March 12, 2024
The Orange Book, Patent Cooperation Treaty, Agitation, Administration, Conference call, Type, PCT, Conference, Database, Schizophrenia, Intelligence, Caregiver, Webcast, Patient, DSM-IV codes, Neuroscience, Fast Track, Food and Drug Administration, CMC, Wind, Orange Book, SCNC, Positive, Microsatellite instability, Dexmedetomidine, Clinical trial, Therapy, Safety, Patent, Research and development, Collection, FDA, Approved drug, Dementia, CAD, Food, Pharmaceutical industry

NEW HAVEN, Conn., March 12, 2024 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience and immuno-oncology, today provided an update on its late-stage TRANQUILITY and SERENITY clinical programs. In addition, the Company reported its financial results for the fourth quarter and full year 2023.

Key Points: 
  • In addition, the Company reported its financial results for the fourth quarter and full year 2023.
  • Net Revenue: Net revenue from IGALMI was $376,000 for the fourth quarter of 2023, compared to $238,000 for the same period in 2022.
  • Net Loss: BioXcel Therapeutics had a net loss of $22.3 million for the fourth quarter of 2023, compared to a net loss of $54.8 million for the same period in 2022.
  • ET to provide an update on recent operational highlights and to discuss its fourth quarter and full year 2023 financial results.

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

Retrieved on: 
Saturday, April 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.

Positive Action, Inc. Launches Pasela Digital Interactive Platform for Social and Emotional Learning

Retrieved on: 
Wednesday, March 27, 2024
Software as a service, PAI, Genome, Education, School, Climate, Differentiated instruction, Public policy, Policy, Bullying, Absenteeism, Student, Positive, Content, Randomized controlled trial, Positive Action campaign, Management

TWIN FALLS, Idaho, March 27, 2024 /PRNewswire/ -- Positive Action, Inc. ("PAI"), a leading education and technology company for evidence-based social and emotional learning (SEL) programs, announced today that it has launched Pasela™, a software as a service (SaaS) platform that enables digital implementation of the Positive Action® Program.

Key Points: 
  • TWIN FALLS, Idaho, March 27, 2024 /PRNewswire/ -- Positive Action, Inc. ("PAI"), a leading education and technology company for evidence-based social and emotional learning (SEL) programs, announced today that it has launched Pasela™, a software as a service (SaaS) platform that enables digital implementation of the Positive Action® Program.
  • "Positive Action remains one of the most effective educational programs available, and Pasela vastly improves the scalability of our products."
  • The Positive Action Program offers more than 2,000 lessons that have been scientifically validated through multiple randomized controlled trials.
  • In addition, the platform includes a suite of fully interactive features that streamline and simplify the implementation process.

Karuna Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Provides General Business Update

Retrieved on: 
Thursday, February 22, 2024
Mental Health, Health, Neurology, Clinical Trials, Pharmaceutical, Biotechnology, Acquisition, PANSS, Blood pressure, KRTX, NEI, FDA, Food, Schizophrenia, PDUFA, Psychiatry, Bristol Myers Squibb, Safety, Psychosis, Therapy, Patient, Congress, Positive, NDA, Pharmaceutical industry

Karuna Therapeutics, Inc. (NASDAQ: KRTX), a biopharmaceutical company driven to discover, develop, and deliver transformative medicines for people living with psychiatric and neurological conditions, today announced financial results for the fourth quarter and full year ended December 31, 2023, and provided a general business update.

Key Points: 
  • Karuna Therapeutics, Inc. (NASDAQ: KRTX), a biopharmaceutical company driven to discover, develop, and deliver transformative medicines for people living with psychiatric and neurological conditions, today announced financial results for the fourth quarter and full year ended December 31, 2023, and provided a general business update.
  • Results from the EMERGENT-2 trial published in The Lancet in December 2023.
  • Announced positive results from the Phase 1b Ambulatory Blood Pressure Monitoring trial in schizophrenia in the fourth quarter of 2023.
  • Presented additional data from the EMERGENT program at the 2023 Neuroscience Education Institute (NEI) Congress and the CNS Summit in the fourth quarter of 2023.

KBRA Assigns Ratings to Franklin BSP Capital Corporation

Retrieved on: 
Tuesday, February 6, 2024
Professional Services, Finance, Risk management, JV, Mergers and acquisitions, Post road, FV, Environment, Outlook, KBRA, Investment, LTV, BDC, Siena, Positive, Security (finance)

In connection with the BDC merger described below, KBRA withdraws the BBB- issuer and senior unsecured debt ratings of Franklin BSP Lending Corporation ("FBLC") and assigns BBB- issuer and senior unsecured debt ratings to Franklin BSP Capital Corporation ("FBCC").

Key Points: 
  • In connection with the BDC merger described below, KBRA withdraws the BBB- issuer and senior unsecured debt ratings of Franklin BSP Lending Corporation ("FBLC") and assigns BBB- issuer and senior unsecured debt ratings to Franklin BSP Capital Corporation ("FBCC").
  • FBLC, which KBRA has rated since 2015, was a non-listed BDC with a $2.8 billion investment portfolio at fair value (FV), as of September 30, 2023.
  • There is no change to FBCC’s Adviser, Franklin BSP Capital Adviser L.L.C, and the underlying strategy remains the same.
  • Additional information regarding KBRA policies, methodologies, rating scales and disclosures are available at www.kbra.com .

KBRA Assigns Rating to Blue Owl Capital Corporation's $600 Million 5.95% Senior Unsecured Notes Due 2029

Retrieved on: 
Thursday, January 18, 2024
Banking, Professional Services, Finance, OBDC, BDC, Business Development Company, KBRA, Positive, SPV, BBB, Blue Owl Capital, Risk, Environment, Investment, Risk management, Lisp (programming language), RIC, Outlook, Bank

KBRA assigns a rating of BBB to Blue Owl Capital Corporation's (NYSE: OBDC or "the company") $600 million 5.95% senior unsecured notes due March 15, 2029.

Key Points: 
  • KBRA assigns a rating of BBB to Blue Owl Capital Corporation's (NYSE: OBDC or "the company") $600 million 5.95% senior unsecured notes due March 15, 2029.
  • OBDC maintains solid access to the capital markets with a diversified funding mix of secured bank facilities, CLOs, and senior unsecured debt.
  • The company is managed by Blue Owl Credit Advisors LLC, an indirect subsidiary of Blue Owl Capital,Inc.
  • The company’s investment strategy coincides with the strategies of Blue Owl Capital Corporation II (KBRA Issuer/Senior Unsecured Debt ratings of BBB/Positive Outlook), Blue Owl Capital Corporation III (KBRA Issuer/Senior Unsecured Debt ratings of BBB/Stable Outlook), and Blue Owl Credit Income Corp. (KBRA Issuer/Senior Unsecured Debt ratings of BBB/Stable Outlook).

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

Retrieved on: 
Tuesday, January 16, 2024
Schizophrenia, Patient, Weight gain, Dementia, Delusion, DSM-IV codes, Positive, SIGMAR1, Rett syndrome, Personalized medicine, Parkinson's disease, Alzheimer's disease, FDA, Therapy, Doctor of Philosophy, PANSS, Hallucination, Pharmaceutical industry

NEW YORK, Jan. 16, 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 and neurodevelopmental disorders, including Alzheimer's disease, Parkinson's disease, Rett syndrome, and schizophrenia, today announced the initiation of the U.S. FDA cleared placebo-controlled Phase 2 trial of ANAVEX®3-71 for the treatment of schizophrenia, which is expected to begin in Q2 2024. ANAVEX®3-71 positive initial Phase 1 results in healthy volunteers were previously reported.1

Key Points: 
  • ANAVEX®3-71 positive initial Phase 1 results in healthy volunteers were previously reported.1
    ANAVEX®3-71 (formerly AF710B) is a dual SIGMAR1 receptor agonist and M1 positive allosteric modulator with agonistic effects.
  • As currently approved treatments only control a subset of symptoms, patients continue to exhibit severe impairments in social and occupational functioning and poor quality of life.
  • The placebo-controlled Phase 2 ANAVEX®3-71-SZ-001 study, will consist of two-parts to explore multiple ascending doses in individuals with schizophrenia followed by a 28-day treatment period in a larger cohort.
  • While current antipsychotic therapies can be effective in managing positive symptoms, like hallucinations and delusions, they may not fully address persistent negative symptoms or cognitive difficulties.

Newron Reports Exceptional One-year Results of Study 014/15 With Evenamide in Treatment-resistant Schizophrenia (TRS)

Retrieved on: 
Thursday, January 4, 2024
Science, Biotechnology, Research, Pharmaceutical, Health, Mental Health, Clinical Trials, Other Health, Psychiatry, XETRA, ADOS, Medication, Positive, Incidence, Clinical Global Impression, CNS, Molecular medicine, PANSS, EKG, Weight gain, Longevity, Peripheral nervous system, TRS, Patient, Pharmaceutical industry

The data demonstrated that treatment with evenamide was associated with sustained clinically significant benefit that increased throughout the one-year course of treatment.

Key Points: 
  • The data demonstrated that treatment with evenamide was associated with sustained clinically significant benefit that increased throughout the one-year course of treatment.
  • In contrast to common clinical experience, no patient “relapsed” during the one-year treatment period.
  • Ravi Anand, Newron’s Chief Medical Officer, said: “Treatment with evenamide as an add-on to antipsychotics in TRS patients has produced benefits that have never been reported before.
  • The presentation for this conference call can be downloaded as of today, January 4, 2024, at 7 am CET, on Newron’s website ( https://www.newron.com/investors/reports-and-presentation/year/2024 ).

EQS-News: Newron reports exceptional one-year results of study 014/15 with evenamide in treatment-resistant schizophrenia (TRS)

Retrieved on: 
Thursday, January 4, 2024
Psychiatry, XETRA, ADOS, Positive, Incidence, Clinical Global Impression, CNS, Molecular medicine, PANSS, EKG, Weight gain, Longevity, Peripheral nervous system, TRS, Patient, Pharmaceutical industry

The data demonstrated that treatment with evenamide was associated with sustained clinically significant benefit that increased throughout the one-year course of treatment.

Key Points: 
  • The data demonstrated that treatment with evenamide was associated with sustained clinically significant benefit that increased throughout the one-year course of treatment.
  • In contrast to common clinical experience, no patient “relapsed” during the one-year treatment period.
  • 25% of all patients achieved “remission” (see “About remission”), never described before in TRS patients.
  • The presentation for this conference call can be downloaded as of today, January 4, 2024, at 7 am CET, on Newron’s website ( https://www.newron.com/investors/reports-and-presentation/year/2024 ).