Catalyst overview
Research summary
This catalyst tracks a Phase 3 data readout for Plozasiran (ARO-APOC3) in Severe hypertriglyceridemia. The expected timing is based on the latest available company guidance and may change.
SHASTA-2,3,4 trials: 5/28/24- SHASTA-3 and SHASTA-4 initiated. 6/23/25- Completed enrollment in SHASTA-3, SHASTA-4, & MUIR-3. Study completion in mid-2026 with subsequent data readout & regulatory submissions. 12/2/25– Granted FDA Breakthrough Therapy Designation. 11/25/25:- Sanofi-Visirna deal grants Sanofi Greater China plozasiran rights; Visirna gets $130M upfront and up to $265M milestones. 03/28/26:- SHASTA-2 OLE showed durable TG reductions; no pancreatitis. Ph3 SHASTA-3/4 & MUIR-3 complete Mid-2026; sNDA Year-End 2026. 04/24/26:- Phase 3 SHASTA-5 added to program; SHASTA-3/4 and MUIR-3 remain ongoing. 05/26/26:- EAS 2026: renal/hepatic impairment data support no dose adjustment; PALISADE pregnancy case reported. Ph3 completes Mid-2026. 06/22/26:- SHASTA-3/4/5 and MUIR-3 Ph3 trials cited with NCT IDs; timelines unchanged. 07/22/26:- SHASTA-3/4 topline positive. Detailed data at ESC Aug 30, 2026. U.S. sNDA planned Q4 2026. 08/04/26:- PRV acquired; plozasiran sNDA planned before end 2026 to expand into sHTG.
Verification
Confirm timing and program details against the company announcement or filing.