Shots: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 pathologyApproval was based on the P-III (Clarity AD) trial assessing Leqembi vs PBO in pts with MCI or mild dementia due to…
Shots: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 populationElecsys pTau217 is an in-vitro diagnostic…
Shots: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-carriersApproval 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 ptsThe TRAILBLAZER-ALZ 2 trial showed…
Shots:Avant Technologies and Austrianova signed a joint venture and licensing agreement to form Klothonova, a 50/50 Nevada-based Joint Venture focused on developing cell-based therapies using encapsulated Klotho-producing cellsUnder the terms of the agreement, Klothonova will leverage Austrianova’s proprietary cell-encapsulation technology to develop and commercialize therapies for Alzheimer’s disease, heart disease, cancer, kidney disease,…
Shots:VectorY has entered into an option & license deal with Shape to assess Shape’s SHP-DB1 (AAV capsid) for vectorized Abs payloads against 3 targets & may secure an exclusive license for their delivery if evaluation succeedsAs per the deal, VectorY will handle development & commercialization of resulting therapies in exchange for an upfront…
Shots:Eisai & Biogen have reported EU launch of Leqembi, starting with Austria on Aug 25, 2025 & Germany on Sep 1, 2025, following EC approval in Apr 2025Approval was based on the P-III (Clarity AD) trial assessing Leqembi (n=757) vs PBO (n=764) in pts with MCI or mild dementia due to AD &…
Shots:Roche has received the CE mark approval for its Elecsys pTau181 test to measure phosphorylated Tau 181 protein to help rule out Alzheimer’s-related amyloid pathologyApproval was backed by a global study of 787 pts (55–80yrs.) across the US, EU, & Australia, showing 93.8% negative predictive value (NPV) based on a 22.5% prevalence of…
Shots:JCR & Acumen have entered into a joint collaboration, option, & license agreement to develop a novel therapy to treat Alzheimer’s disease leveraging JCR’s J-Brain Cargo techAs per the deal, JCR will receive an upfront payment & an option payment if Acumen exercises its exclusive option to develop, manufacture, & commercialize up to…
Shots:Cognition has reported topline P-II (MAGNIFY/COG2201) trial data assessing zervimesine (200mg, QD, PO) vs PBO in adults with GA secondary to dry AMD; trial concluded after enrolling ~100 of 246 planned subjectsIn the trial, nearly 2/3 pts completed 12mos. & 1/3 completed 18mos. of dosing, showing a 28.6% slower GA progression & ~12%,…
Shots:Veravas has launched VeraBIND Tau to detect both symptomatic & pre-symptomatic pts with Alzheimer's disease (AD) or other tau-related neurodegenerative disorders (tauopathies)In an analytical verification study, VeraBIND Tau showed 96% sensitivity, 90% specificity, & 92% agreement with tau PET imaging, detecting Alzheimer’s-related tau & offering VeraBIND Tau score, a semi-quantitative measure of pathologically…

