Severe hypertriglyceridemia (sHTG)
IONSIonis PharmaceuticalsCatalyst overview
Research summary
This catalyst tracks a Approved update for IONIS-APOCIII-LRx (Olezarsen) in Severe hypertriglyceridemia (sHTG). The expected timing is based on the latest available company guidance and may change.
6/25/24- Enrollment completed in CORE, CORE2 & ESSENCE trials. 5/19/25- ESSENCE topline data announced. 9/2/25- Positive CORE & CORE2 topline results reported. Submit sNDA by YE 2025. 11/8/25- Detailed data from CORE & CORE2 studies presented at AHA'25. 01/11/26:- sNDA submitted to FDA for sHTG TRYNGOLZA; potential 2026 approval and launch anticipated. 02/26/26:- FDA accepted sNDA for olezarsen in sHTG with Priority Review; PDUFA action date June 30, 2026. 06/04/26:- New Ph3 CORE/CORE2 analyses to present at ADA, NLA, ENDO June 6-14, 2026. PDUFA June 30, 2026. 06/24/26:- FDA approved TRYNGOLZA for sHTG to reduce TG and pancreatitis risk. U.S. availability July. 08/20/26:- One-year open-label extension data at ESC 2026 Aug 28. EMA reviewing sHTG application.
Verification
Confirm timing and program details against the company announcement or filing.