Arrowhead Says US FDA Includes Plozasiran in Split Real Time Application Review Pilot Program
MT newswire2026/10/07 12:1108:11 AM EDT, 10/07/2026 (MT Newswires) -- Arrowhead Pharmaceuticals (ARWR) has been granted an entry by the US Food and Drug Administration into the Split Real Time Application Review pilot program for the company's planned supplemental new drug application, or sNDA, for plozasiran for severe hypertriglyceridemia, Arrowhead said Wednesday. The pilot's goal is to shorten the time between a complete sNDA submission and FDA action date, the company said. Arrowhead said it remains on track to submit an sNDA for plozasiran by year-end and will then seek regulatory approvals in other jurisdictions. Shares of the company were up 1.7% in recent pre-bell activity on Wednesday.
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