Company: APM
Filing Date: 2025-07-15
Form Type: DRS
Source: 0001213900-25-063906
Chunk: 325

Company: Aptorum Group Ltd
Filing Date: 2025-07-15
Form: DRS
Chunk 325
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 Eli Lilly announced that the FDA has approved its anti -amyloidbeta monoclonal antibody Kisunla (donanemab) for the treatment of patients with MCI and mild AD ( https: // investor.lilly.com /news -releases /news -release -details /lillys -kisunlatm - donanemab-azbt - approved-fda - treatment-early). DiamiR believes that these approvals support DiamiR’s thesis that enrolling earlier stage MCI and/or mild dementia patients is an effective strategy for drug developers. In July 2023, CMS announced Medicare coverage for lecanemab priced at $26,500 per year. While DiamiR’s CogniMIR ®test was not used in either of these studies, DiamiR believes that over time, blood -basedtests for AD will play a role in identifying the “right patient for the right drug”, and that DiamiR’s test may, upon completion of additional studies, become a useful tool for this use. Currently, few diagnostic tools are available for identifying these early -stagesubjects, and those that are available maybe limited in their effectiveness. Historically, these tests have been based on imaging and cerebrospinal fluid analysis as well as more recently on the analysis or protein markers in the blood. DiamiR believes that its innovative platform technology may prove to have utility in identification of pre -symptomatic, MCI and early dementia patients, opening up a significant opportunity for DiamiR to develop a pharma services business to support clinical studies for Alzheimer’s therapies. In May 2025, the FDA granted 510(k) clearance for the Fujirebio’s Lumipulse ®G pTau 217/ β -Amyloid1 -42Plasma Ratio in -vitrodiagnostic (IVD) test for the assessment of amyloid pathology in patients being evaluated for Alzheimer’s disease and other causes of cognitive decline. The test, intended for use in adult patients aged 50 years and older presenting at a specialized care setting with signs and symptoms of cognitive decline, is the first FDA cleared blood -basedIVD test in the U.S. to aid to identify patients with amyloid pathology associated with AD. Currently it is accepted that AD dementia is preceded by 10 -20years of the disease development, initially without clinical symptoms (pre -symptomaticAD), and then eventually manifested as MCI, followed by onset of dementia and clinical AD symptoms. Not