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BioWorld - Wednesday, July 9, 2025
Home » neurofilament light chain

Articles Tagged with ''neurofilament light chain''

Neuronata-R

Corestemchemon preps US BLA filing for stem cell ALS therapy

June 10, 2025
By Marian (YoonJee) Chu
No Comments
Corestemchemon Inc. is planning to file a BLA for Neuronata-R (lenzumestrocel) by the end of 2025 to gain accelerated approval from the U.S. FDA, company officials confirmed to BioWorld during a June 2 interview. Neuronata-R is an autologous bone marrow-derived mesenchymal stem cell therapy that first gained approval in South Korea in 2014 to delay the progression of amyotrophic lateral sclerosis (ALS), a progressive neurodegenerative disorder also known as Lou Gehrig’s disease.
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Neuronata-R

Corestemchemon preps US BLA filing for stem cell ALS therapy

June 9, 2025
By Marian (YoonJee) Chu
No Comments
Corestemchemon Inc. is planning to file a BLA for Neuronata-R (lenzumestrocel) by the end of 2025 to gain accelerated approval from the U.S. FDA, company officials confirmed to BioWorld during a June 2 interview. Neuronata-R is an autologous bone marrow-derived mesenchymal stem cell therapy that first gained approval in South Korea in 2014 to delay the progression of amyotrophic lateral sclerosis (ALS), a progressive neurodegenerative disorder also known as Lou Gehrig’s disease.
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Genetic/congenital

CMT2E murine model reveals early axonal damage

March 21, 2025
Charcot-Marie-Tooth disease type 2E (CMT2E) is a slow and progressive neuropathy characterized by axonal dysfunction. Its clinical phenotype includes muscle weakness and atrophy, sensory loss and reduced nerve conduction velocity, among others.
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Multiple sclerosis, neurons concept art.

Interim analysis allows Immunic to stick with phase III MS studies

Oct. 22, 2024
By Lee Landenberger
It’s a go for the two phase III Ensure studies of Immunic Inc.’s lead asset in treating relapsing multiple sclerosis. An unblinded data monitoring committee’s interim futility analysis concluded that the placebo-controlled, pivotal studies using vidofludimus calcium may continue as planned, with the program expected by the company to be completed in 2026.
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Cerebellum, brain stem, spinal cord

Alterity’s ATH-434 shows early response in multiple system atrophy

July 23, 2024
By Tamra Sami
Aussie biotech Alterity Therapeutics Ltd. released interim data of an open-label phase II trial for lead candidate ATH-434 for treating multiple system atrophy that showed 43% of participants improved, with 29% showing either stable or improved neurological symptoms.
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Cerebellum, brain stem, spinal cord

Alterity’s ATH-434 shows early response in multiple system atrophy

July 18, 2024
By Tamra Sami
Aussie biotech Alterity Therapeutics Ltd. released interim data of an open-label phase II trial for lead candidate ATH-434 for treating multiple system atrophy that showed 43% of participants improved, with 29% showing either stable or improved neurological symptoms.
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Siemens NfL Assay

Siemens gets CE mark for neurofilament light chain blood test for MS

June 17, 2024
By Shani Alexander
Siemens Healthineers AG has received CE mark for a neurofilament light chain assay to help with the early diagnosis of multiple sclerosis and aid in predicting the risk of relapse in patients suffering from the disease. The test developed in collaboration with Novartis Pharma AG will be launched in Europe later this year.
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Roche MS test secures FDA breakthrough device designation

Nov. 10, 2023
By Shani Alexander
The U.S. FDA granted Roche Holding AG breakthrough device designation for its Elecsys Neurofilament Light Chain test for multiple sclerosis. The Elecsys NfL test can aid in the detection of disease activity in adults, 18-55 years old, with relapsing-remitting multiple sclerosis or secondary progressive multiple sclerosis. It also provides critical information for managing the disease.
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Nodthera says oral NLRP3 inhibitor reduces inflammation in the brain

July 11, 2023
By Nuala Moran
Nodthera Ltd. claims to be first to demonstrate it is possible to modulate the NLRP3 inflammasome in the brain, after showing there were reductions in inflammatory and disease-specific biomarkers in blood and cerebrospinal fluid after seven days of daily administration of its lead product, NT-0796, an oral NLRP3 inhibitor.
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Clinical data illustration

NfL yardage gain for Denali as marker adds weight to MPS II thesis

June 20, 2023
By Randy Osborne
For the second time in a week, measures of serum neurofilament light chain (NfL) took center stage, this time as Denali Therapeutics Inc. unveiled interim data from the open-label, single-arm phase I/II study testing DNL-310 in children with mucopolysaccharidosis II (MPS II), also known as Hunter syndrome.
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