Biological Markers
BridgeBio Shifts Filing Plans After Phase 3 Success in Rare Disease Drug BBP-418
BridgeBio; BBP-418; Phase 3 success; limb-girdle muscular dystrophy type 2I/R9; FDA filing; rare disease drug; NDA (New Drug Application); ribitol; full approval; biomarker; acoramidis; commercial strategy
ESMO Spotlight: Flagship ADCs move into early-stage cancer to validate chemo-displacement ambitions
ESMO 2025; antibody-drug conjugates; ADCs; early-stage cancer; chemo-displacement; trastuzumab deruxtecan; ENHERTU; datopotamab deruxtecan; DATROWAY; breast cancer; HER2-positive; triple-negative breast cancer; biomarkers; toxicity management
Lunit AI Predicts Immunotherapy Outcomes in Colorectal, Kidney, and Lung Cancer at ESMO 2025
Lunit AI; SCOPE IO; immunotherapy; colorectal cancer; kidney cancer; lung cancer; biomarkers; ESMO 2025; treatment prediction; AI pathology
FDA Considers Noninvasive Endpoint for MASH Trials, Boosts Biotech Shares
FDA; noninvasive endpoint; liver disease; MASH; clinical trials; biomarker; biotech stocks; Madrigal Pharmaceuticals; Viking Therapeutics; Inventiva; Altimmune
Personalizing Metabolic Care with Digital Twins: Recent Developments
digital twins; metabolic health; AI healthcare; personalized medicine; biomarkers; diabetes management; obesity reversal; real-time guidance; GLP-1; Twin Health
Roche Doubles Down on Alzheimer’s with Next-Gen Amyloid-Lowering Drug Trontinemab
Roche; Alzheimer’s disease; trontinemab; amyloid-lowering drug; Brainshuttle; Phase III trial; TRONTIER studies; drug development; biomarkers; early intervention
Advancements in Predicting Tumor Response and Expanding Therapy Eligibility Using Epigenomic Biomarkers
epigenomic biomarkers; tumor response prediction; personalized cancer therapy; DNA methylation; AI-driven diagnostics
ALTO-203 Misses Depression Endpoint but Shows Positive Biomarker and Cognitive Signals
ALTO-203; Alto Neuroscience; Phase 2 trial; major depressive disorder; EEG biomarkers; theta/beta ratio; attention; wakefulness; William Blair; drug activity; future development
Recent Developments in Immune Profiling for Early Immuno-Oncology Trials
immune profiling; immuno-oncology; clinical trials; AI in immunotherapy; multi-omic strategies; tumor microenvironment; spatial proteomics; biomarker discovery; personalized medicine
Roche Advances Prasinezumab Into Phase III Trials for Parkinson’s Despite Mixed Phase II Results
Roche; prasinezumab; Parkinson’s disease; Phase III trial; clinical trials; alpha-synuclein antibody; Prothena; PADOVA study; PASADENA study; biomarker; disease-modifying treatment