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Arrowhead's Plozasiran delivers deep TG reductions and AP risk drop in sHTG

Aug 30, 2026, 11:33 AM EDT1 sourcesAI-analyzed

Why it may matterVerify against the original reporting

Compelling TG and AP risk reductions across two pivotal studies raise the probability of regulatory approval and commercial launch; sNDA timing by end-2026 with Priority Voucher adds optionality and potential upside on favorable regulatory decision.

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Arrowhead reports SHASTA-3/SHASTA-4 show deep TG reductions and meaningful AP risk reductions in broad sHTG. Median TG declines reached 79% and 81% at 12 months, with over 90% under 500 mg/dL and more than half under 150 mg/dL. The company intends an sNDA with the FDA by end-2026, aided by a Priority Review Voucher.

SHASTA-3/SHASTA-4: TG down 79% and 81% at Month 12.
Over 90% hit TG <500 mg/dL; >50% hit <150 mg/dL at Month 12.
AP events down 78%; higher-risk TG≥500 with prior AP sees 91% reduction.
Highest-risk TG≥880 mg/dL with prior AP: 100% reduction vs placebo.
sNDA planned by end-2026; Priority Review Voucher purchased.

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