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Arrowhead's Plozasiran Phase 3 Results Strengthen Redemplo Prospects for FCS

Jul 22, 2026, 2:46 PM EDT1 sourcesAI-analyzed

Why it may matterVerify against the original reporting

Strong Phase 3 efficacy on triglyceride reduction and pancreatitis outcomes, favorable safety, and near-term NDA path; precedent from similar programs suggests swift valuation re-rating on positive pivotal data; ultimate upside depends on FDA approvals and commercialization.

AI summary

What happened, with direct paths to the underlying reporting

Arrowhead reported Phase 3 plozasiran results showing robust triglyceride reductions and fewer pancreatitis events, prompting an FDA supplemental NDA submission planned for by end-2026. The data support a favorable safety profile and potential multi-region approvals under the Redemplo brand, driving near-term upside and longer-term regulatory milestones.

Phase 3 SHASTA-3/4 hit primary endpoint; TGs reduced vs placebo.
Plozasiran 25 mg quarterly reduced TG by 79% and 81% at 12 months.
In TG>500 mg/dL group, pancreatitis events fell 78%.
100% pancreatitis reduction in TG>880 mg/dL with prior pancreatitis.
FDA supplemental NDA planned by end-2026; Redemplo approved in multiple regions.

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