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Labcorp has launched the Elecsys pTau-181 test to measure phosphorylated Tau 181 protein to help rule out Alzheimer’s-related amyloid pathology in individuals (≥55yrs.)
The test delivers a 97.9% negative predictive value to help rule out Alzheimer’s pathology in symptomatic pts & offers a less invasive, more accessible alternative to brain scans or lumbar punctures…
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The US FDA has received 510(k) premarket notification for the multi-analyte algorithmic blood test to diagnose Alzheimer’s disease
Submission was backed by data across three independent cohorts & 1,800+ pts, published in the Alzheimer’s & Dementia: Diagnosis, Assessment & Disease Monitoring
The blood test uses Quanterix’s Simoa tech to integrate five AD biomarkers (p-Tau217,…
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SciNeuro has entered into a global licensing & collaboration deal with Novartis to advance its amyloid beta-targeted antibody program for Alzheimer’s disease
The program has identified de novo antibody candidates using SciNeuro’s blood–brain barrier shuttle tech, with Novartis leading global development & commercialization after collaboration on early development
As per the deal, SciNeuro will…
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Neurodegenerative care is at a pivotal inflection point, shifting from symptomatic relief to strategies that restore cellular resilience. Blarcamesine (ANAVEX 2-73) advances this upstream approach by activating SIGMAR1 to rebalance autophagy, targeting a core driver of neurodegeneration
Phase IIb/III findings demonstrated a statistically significant slowing of cognitive decline, with the most pronounced benefit seen in patients carrying the…
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ADEL has entered into an exclusive worldwide license agreement with Sanofi for the development & commercialization of ADEL-Y01 & related backup compounds
As per the deal, ADEL will receive a non-refundable payment of $80M upfront plus development & commercial milestones, representing the total deal value of ~$1.04B, tiered royalties on net sales ranging up…
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The Japanese PMDA has received NDA for Leqembi SC autoinjector to treat adults with early Alzheimer’s disease (AD)
NDA is supported by sub-studies from the P-III (Clarity AD) OLE study in pts with mild cognitive impairment due to AD or mild AD dementia, showing that Leqembi (500mg, SC: two 250mg injections) administered QW, provided exposure equivalent to Q2W IV…
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The UK’s MHRA has approved Leqembi (IV, Q4W) as a maintenance therapy for early Alzheimer’s pts after completing 18mos. of Q2W Leqembi treatment
Leqembi is approved in 51 countries for early AD & under review in 9, while the Q4W maintenance is approved in the UK, China, the US, & others, with 4 applications…
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Health Canada has approved Leqembi with conditions for adults with mild cognitive impairment or mild dementia due to early Alzheimer’s disease who are ApoE ε4 non-carriers or heterozygotes with confirmed amyloid pathology
Approval was based on the P-III (Clarity AD) trial assessing Leqembi vs PBO in pts with MCI or mild dementia due to…
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The US FDA has cleared the Elecsys pTau181 test to measure phosphorylated Tau 181 protein to help rule out Alzheimer’s-related amyloid pathology in individuals (≥55yrs.)
Elecsys pTau181 was evaluated in a non-interventional study of 312 participants, showing 97.9% negative predictive value (NPV) in an early disease-stage, low-prevalence population
Elecsys pTau217 is an in-vitro diagnostic…
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The EC has approved Kisunla to treat early symptomatic Alzheimer’s disease in adults with mild impairment or dementia & confirmed amyloid pathology who are ApoE4 heterozygotes or non-carriers
Approval was based on P-III (TRAILBLAZER-ALZ 2) study (n=1736, ≥18mos.) & P-IIIb (TRAILBLAZER-ALZ 6) trial (n=843, 60-85yrs.) assessing Kisunla (QM) vs PBO in AD pts
The TRAILBLAZER-ALZ 2 trial showed…

