Sobi receives positive CHMP opinion for TRYNGOLZA® (olezarsen) for the treatment of severe hypertriglyceridemia (sHTG)
RegulatorypositiveTRYNGOLZAPositive
AI Analysis
Summary
Sobi received a positive CHMP opinion for TRYNGOLZA (olezarsen) for severe hypertriglyceridemia, supported by Phase 3 CORE and CORE2 data showing up to 72% triglyceride reduction and an 85% reduction in acute pancreatitis events versus placebo.
Clinical Trial Data
Phase
Phase 3
Primary Endpoint
Met
Outcome Details
Positive CHMP opinion for TRYNGOLZA (olezarsen) for severe hypertriglyceridemia, based on Phase 3 CORE and CORE2 results showing up to 72% placebo-adjusted mean reduction in triglycerides and an 85% reduction in acute pancreatitis event rate versus placebo.
Importance:8/10
Sentiment:
0.80
CHMPpositive opinionolezarsenTRYNGOLZAsevere hypertriglyceridemiasHTGEU regulatoryacute pancreatitisCORECORE2
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Published by PR Newswire Biotech on October 16, 2026 11:12 AM