Arrowhead develops RNA interference medicines; REDEMPLO (plozasiran) is approved for familial chylomicronemia syndrome in the U.S., EU, Canada, Australia and China, but not yet for severe hypertriglyceridemia.
REDEMPLO, a quarterly injection that lowers triglycerides, is approved for the rare disease FCS. In SHASTA-3 and SHASTA-4, it cut triglycerides 79-81% and acute pancreatitis events 78% in severe hypertriglyceridemia, a much larger market. Arrowhead plans to file by year-end 2026 under FDA's STAR pilot, which allows a six-month review. Ionis's olezarsen, which also targets APOC3, won approval in that indication in June 2026. Cash and investments of $1.57 billion fund a broad RNAi pipeline.
Thesis checklist
0 risks need attention
Why it is in this state
The evidence, what would weaken it and the source filing
Why it is in this state
The evidence, what would weaken it and the source filing
Why it is in this state
The evidence, what would weaken it and the source filing
Why it is in this state
The evidence, what would weaken it and the source filing
Next decision point
Tests: sHTG application is submitted and approved
Does Arrowhead submit the sHTG application on schedule, and does FDA accept it under the STAR pilot?
Strong, inconclusive and weak outcomes
What to look for in the result and how each would move the checklist
Price and material events
Select an event marker to read the update below. Marker colors show Thesis status.
REDEMPLO is approved in FCS; the larger severe hypertriglyceridemia filing comes by year-end
REDEMPLO approved in FCS; sNDA label on pancreatitis differentiation determines plozasiran's larger sHTG market reach
REDEMPLO approved in five markets; sHTG label expansion with pancreatitis claim vs. approved olezarsen is next value inflection
REDEMPLO approved and commercially accelerating; the bet is whether Phase 3 sHTG data earns a label expansion into a market dwarfing FCS
About this history: every entry shows when the Thesis moved and what it said. The reasoning behind each move (the evidence, the analysis and the source filing) and the earnings write-ups are part of a subscription.
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Disease areas: Kidney diseases, Neuromuscular diseases, Neurology and pain, Infectious diseases, Lung and respiratory diseases, Liver and digestive diseases, Obesity, diabetes and heart disease, Rare genetic and metabolic diseases
Catalyst calendar · Upcoming FDA decisions · Thesis changes
Competitive landscape
38 peers tracked
Cash: Market-data provider estimate; measurement period unavailable.
Debt: Market-data provider estimate; a complete comparable filing balance is unavailable.
Quarterly burn: Estimated from trailing free cash flow; measurement period unavailable.
Net cash and estimated runway require verified matching measurement periods. Missing debt components are not assumed to be zero.
Runway: No underlying guidance available.