Movement Alert｜Arrowhead Pharmaceuticals Pre-Market Rise 6.66%, FDA Review Pilot Entry Speeds Plozasiran sNDA Path

Market Focus10-14

On October 14, Arrowhead Pharmaceuticals rose 6.66% in Pre-Market Trading, trading at $62.6/share, with turnover of $1.6679 million.

The move followed the company’s disclosure that the FDA accepted Plozasiran for severe hypertriglyceridemia into the Split Real Time Application Review pilot, which can shorten review time for the planned supplemental NDA to 6 months rather than the standard 10 months, while allowing Arrowhead to retain its priority review voucher.

The regulatory update builds on earlier late-stage momentum: Plozasiran previously met primary and secondary endpoints in two phase 3 studies in severe hypertriglyceridemia, with reports highlighting meaningful triglyceride reductions, fewer acute pancreatitis events, and a favorable safety profile. Arrowhead has said it plans to submit the sNDA by year-end, so the faster review framework strengthens visibility on the regulatory timeline.

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