News | January 09, 2026
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 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
REDEMPLO is the first and only Health Canada-approved siRNA therapy for FCS
The privately held biotech brings a first-in-class oncology program focused on small molecule–targeted protein degradation
The trial aims to measure AF burden—the percentage of time patients spend in arrhythmia—as its primary efficacy endpoint
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
WCK 5222 is the first New Chemical Entity (NCE) discovered and developed in India to be submitted for pan-European marketing authorisation
The work will leverage ProBioGen’s CHO.RiGHT expression platform, powered by its proprietary DirectedLuck transposase technology, alongside PsiBot smart automation
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