Neurofilament light polypeptide

Denali Therapeutics Reports Third Quarter 2023 Financial Results and Business Highlights

Retrieved on: 
Tuesday, November 7, 2023
Neurofilament light polypeptide, MPS II, CLE, Biomarker, Therapy, MS, BioRxiv, ETV, Ulcerative colitis, BBB, ALS, PTV, ATV, ROFN, Definitive, Traffic barrier, Hunter syndrome, Phase 10, Denali, MPS, Antibody, Biology, Safety, Patient, AFL, Plaque, Fluid mechanics, ASO, ARIA, RIPK1, Asos, Research, Cerebrospinal fluid, ISR, SGSH, DSM-IV codes, Nerve, Brain, Society, Total, OTV, N-sulfoglucosamine sulfohydrolase, Hunting, LUMA, Glycogen storage disease, Manuscript, UC, CSF, Amyloid-related imaging abnormalities, Takeda, COMPASS, Pathology, CNS, Sanfilippo, Neuroinflammation, Collaboration, Multiple sclerosis, Sanfilippo syndrome, IDS, Cognition, Mutation, SAN, Pharmaceutical industry, Medical imaging, Fine chemical, Cryptocurrency, Biogen, LRRK2, Metabolism, Sanofi

SOUTH SAN FRANCISCO, Calif., Nov. 07, 2023 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (Nasdaq: DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain barrier (BBB) for the treatment of neurodegenerative diseases and lysosomal storage diseases, today reported financial results for the third quarter ended September 30, 2023, and provided business highlights.

Key Points: 
  • SOUTH SAN FRANCISCO, Calif., Nov. 07, 2023 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (Nasdaq: DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain barrier (BBB) for the treatment of neurodegenerative diseases and lysosomal storage diseases, today reported financial results for the third quarter ended September 30, 2023, and provided business highlights.
  • Denali has selected five ASO targets for further development and is focused on advancing two OTV candidates towards clinical development.
  • 2023 Guidance on Operating Expenses:
    Cash, cash equivalents, and marketable securities were approximately $1.12 billion as of September 30, 2023.
  • General and administrative expenses were $25.3 million and $23.3 million for the three months ended September 30, 2023 and 2022, respectively.

BioVie Announces Completion of Last Patient Treatment Visit in Phase 3 Trial of NE3107 in Mild to Moderate Alzheimer's Disease

Retrieved on: 
Tuesday, September 26, 2023
Database, AFL, Risk, SAP, Dementia, Patient, AD, FDA, Neurofilament light polypeptide, EDC, Pharmaceutical industry

Enrolled patients had underlying medical conditions that are known risk factors for dementia that NE3107 has the potential to improve.

Key Points: 
  • Enrolled patients had underlying medical conditions that are known risk factors for dementia that NE3107 has the potential to improve.
  • “Now that the last patient has completed the last treatment visit, our clinical team can begin the process leading to database lock,” stated Dr. Joseph Palumbo, BioVie’s Head of R&D and Chief Medical Officer.
  • “We do not need to show a reversal of cognitive decline as demonstrated in the Phase 2 trial for the current trial to be considered successful.
  • The trial’s Statistical Analysis Plan (SAP) that pre-specifies the analyses and treatment populations and subgroups will be submitted to the FDA prior to locking the EDC.

Athira Pharma Reports Second Quarter 2023 Financial Results and Pipeline and Business Updates

Retrieved on: 
Thursday, August 10, 2023
ACT, Cognition, Amgen, Communication, Enzyme inhibitor, GFAP, Doctor of Philosophy, Glial fibrillary acidic protein, AFL, UCLA Anderson School of Management, Survival, Food and Drug Administration, GST, G&A, Toxicity, Biomarker, Inflammation, Pathology, R, Massachusetts Institute of Technology, Plasma, Business administration, AAIC, Patient, AbbVie, Investment, Division, Administration, Corporation, Frontotemporal dementia, Management, Growth, ADAS, Research and development, FDA, Master of Business Administration, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, IND, Chemical engineering, ALS, Therapy, Food, Neurofilament light polypeptide, Neuroinflammation, Conference, Fine chemical, Pharmaceutical industry, Medical imaging, Cryptocurrency, Science

BOTHELL, Wash., Aug. 10, 2023 (GLOBE NEWSWIRE) -- Athira Pharma, Inc. (NASDAQ: ATHA), a late clinical-stage biopharmaceutical company focused on developing small molecules to restore neuronal health and slow neurodegeneration, today reported financial results for the quarter ended June 30, 2023, and provided pipeline and business updates.

Key Points: 
  • Based on FDA interactions, the Company believes that all registrational pathways remain viable and contingent on LIFT-AD results.
  • The Company appointed seasoned finance and corporate strategy executive Andrew Gengos as Chief Financial Officer and Chief Business Officer.
  • R&D expenses were $21.6 million for the quarter ended June 30, 2023, compared with $14.8 million for the quarter ended June 30, 2022.
  • G&A expenses were $10.0 million for the quarter ended June 30, 2023, compared with $8.8 million for the quarter ended June 30, 2022.

Fujirebio expands its assay menu in the field of neurodegenerative diseases with the launch of the fully automated Lumipulse® G NfL CSF and Lumipulse® G NfL Blood tests

Retrieved on: 
Tuesday, March 28, 2023
Medical Supplies, Neurology, Genetics, Cardiology, Biotechnology, Managed Care, Health, Other Science, Science, Cerebrospinal fluid, AFL, Prognosis, Multiple sclerosis, DSM-IV codes, Traumatic brain injury, Frontotemporal dementia, Fujirebio, CSF, Research, ALS, Neurofilament light polypeptide, Medical imaging

Group Holdings Inc. and its wholly-owned subsidiary Fujirebio today announced the availability of the Lumipulse G NfL CSF and Lumipulse G NfL Blood assays for the fully automated random-access LUMIPULSE® G immunoassay systems.

Key Points: 
  • Group Holdings Inc. and its wholly-owned subsidiary Fujirebio today announced the availability of the Lumipulse G NfL CSF and Lumipulse G NfL Blood assays for the fully automated random-access LUMIPULSE® G immunoassay systems.
  • These CLEIA (chemiluminescent enzyme immunoassay) assays allow for the quantitative measurement of Neurofilament light (NfL) in human Cerebrospinal fluid (CSF) and plasma/serum, respectively, within just 35 minutes.
  • This standardized immunoassay system family is widely available and used in routine labs active in the field of neurological diseases with its current assay menu.
  • The LUMIPULSE G platform meets the necessary throughput, quality, and regulatory requirements to support possible future routine use of NfL in addition to the existing portfolio.

Prilenia Announces Topline Results for Pridopidine in Phase 2 ALS Study

Retrieved on: 
Thursday, February 23, 2023
Health, Neurology, Clinical Trials, General Health, Pharmaceutical, Biotechnology, Safety, Therapy, Mouse, Disease, Research, Massachusetts General Hospital, FDA, HD, Patient, Department of Neurology, Xuanwu hospital, DSM-IV codes, AFL, Harvard Medical School, Neurofilament light polypeptide, Human, Master of Science, Hospital, Multiple sclerosis, Speech, ALS, Pharmaceutical industry, Medical device

“In particular, the impact of pridopidine on speech measures was notable, likely due to its S1R mechanism of action.

Key Points: 
  • “In particular, the impact of pridopidine on speech measures was notable, likely due to its S1R mechanism of action.
  • This study showed for the first time in humans that S1R agonism with pridopidine has the potential to impact ALS,” said Dr. Michael R. Hayden, CEO and Founder of Prilenia.
  • “This study adds to the growing body of evidence that S1R activation has beneficial neuroprotective effects, and this gives us a compelling rationale for further development of pridopidine in ALS.
  • Additional analyses are underway, including from the open-label extension study, and complete study results will be presented at upcoming scientific meetings.

Enigma Biointelligence Collaborates with Siemens Healthineers CLIA Laboratory to Provide Laboratory Services in the Field of Neurodegenerative Diseases

Retrieved on: 
Tuesday, November 9, 2021
Biotechnology, Health, Science, Research, Clinical Trials, Neurodegeneration, Biomarker, Industry, Plasma, Lists of publishing companies, AFL, Neurofilament light polypeptide, Siemens, EBI, Siemens Healthineers, Â, CA, Research, Neuro, Enigma, Patient, Medical imaging

Enigma Biomedical Intelligence (EBI) today announced that it is working together with the Siemens Healthineers CLIA Laboratory in Berkeley, CA, to provide blood testing capabilities to academic and commercial institutions interested in research in the field of neuro-degenerative diseases.

Key Points: 
  • Enigma Biomedical Intelligence (EBI) today announced that it is working together with the Siemens Healthineers CLIA Laboratory in Berkeley, CA, to provide blood testing capabilities to academic and commercial institutions interested in research in the field of neuro-degenerative diseases.
  • Siemens Healthineers CLIA Laboratory has and will perform plasma-based tests in order for EBI to correlate the test results with clinical data focused on the needs of EBIs collaborators.
  • Siemens Healthineers CLIA laboratory, currently offers a range of testing services for different neuro biomarkers, including Neurofilament Light chain (NfL).
  • Lee-Anne Gibbs, President of Enigma Biomedical Group said, This is another major step forward in enabling critical biomarker research into neurodegenerative diseases.

Michigan-based Memorial Healthcare: First in U.S. to use new Neurofilament Light Chain technology for multiple sclerosis patients

Retrieved on: 
Tuesday, September 10, 2019
Biomarkers, Neurofilament light polypeptide, Neurofilament, Neurology

OWOSSO, Mich., Sept. 10, 2019 /PRNewswire/ -- The Memorial Healthcare Institute for Neurosciences and Multiple Sclerosis, and its Chief of Neurology, Rany Aburashed, D.O., are the first in the U.S. to use Neurofilament Light Chain testing prospectively for patients with multiple sclerosis.

Key Points: 
  • OWOSSO, Mich., Sept. 10, 2019 /PRNewswire/ -- The Memorial Healthcare Institute for Neurosciences and Multiple Sclerosis, and its Chief of Neurology, Rany Aburashed, D.O., are the first in the U.S. to use Neurofilament Light Chain testing prospectively for patients with multiple sclerosis.
  • We are optimistic that this testing can hopefully help us determine the degree of underlying structural damage occurring from a condition.
  • Neurofilament light chain is a polypeptide that provides the structural framework and support to nerve cells.
  • For more information about Memorial Healthcare, its Institute for Neurosciences and Multiple Sclerosis or the neurofilament light chain (NfL) research study, visit memorialhealthcare.org/service/neurology or call 989-723-1390.