Arrowhead Pharmaceuticals (NASDAQ: ARWR) Confirmed on the Fiscal Q2 2026 Conference Call Tuesday August 4 That the Company Has Acquired a Priority Review Voucher (PRV) Providing the Option to Shorten a Future FDA New Drug Application Review From the Standard 10-Month Timeline to a 6-Month Timeline; Simultaneously REDEMPLO (Plozasiran, ApoC-III-Targeting siRNA Approved November 2025 for Familial Chylomicronemia Syndrome and Now Advanced to Phase 3 SHASTA-3 and SHASTA-4 Positive Win July 23, 2026 for Severe Hypertriglyceridemia) Prescription Volume Approximately Doubled Over Fiscal Q3 With Continued Momentum Into the Current Quarter
Arrowhead Pharmaceuticals (NASDAQ: ARWR) confirmed on the Fiscal Q2 2026 conference call Tuesday August 4, 2026 that the company has acquired a Priority Review Voucher (PRV), a transferable FDA-issued voucher that provides the option to shorten a future FDA new drug application review from the standard 10-month timeline to a 6-month timeline. PRVs are issued to sponsors that develop drugs for rare pediatric diseases, tropical diseases, or specific medical countermeasures under FDA statutory authority; they are transferable and can be sold on the secondary market where recent transactions have priced PRVs in the $100-200 million range. Arrowhead did not disclose the specific candidate to which the PRV will be applied but the timing (following the July 23, 2026 Phase 3 SHASTA-3 and SHASTA-4 positive readouts for plozasiran/Redemplo in severe hypertriglyceridemia) suggests the voucher may support the sNDA filing planned before end of 2026 for the severe hypertriglyceridemia indication. Separately, REDEMPLO (plozasiran) prescription volume has approximately doubled over fiscal Q3 following the November 2025 FDA approval for familial chylomicronemia syndrome, with continued momentum into the current quarter. Arrowhead management expressed continued satisfaction with the launch trajectory approximately 8.5 months after initial approval.