Oculis’ Privosegtor wins FDA breakthrough therapy status for Optic Neuritis
The FDA designation follows visual-function results from the Phase 2 ACUITY trial
The FDA designation follows visual-function results from the Phase 2 ACUITY trial
The trial aims to measure AF burden—the percentage of time patients spend in arrhythmia—as its primary efficacy endpoint
Blood tests measuring biomarkers such as p-tau217 are emerging as accurate, accessible alternatives
The trial’s primary endpoint is the mean change in HbA1c from baseline, while secondary endpoints include changes in fasting blood glucose, body weight, and overall safety
Ventyx's clinical pipeline includes multiple small molecules with potential for oral therapies addressing chronic inflammation
The approval follows robust data from the SWIFT and ANCHOR Phase III trials
The therapy was well tolerated through Week 24, with a safety profile consistent with Alumis’ Phase 2 data
ADHD is a common, chronic neurodevelopmental disorder that often begins in childhood and can persist into adulthood
The investigational subcutaneous hepcidin mimetic peptide is designed to regulate iron and red blood cell production
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