Peptide News Digest

#Prv

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Regulatory · View digest

Arrowhead Pharmaceuticals (NASDAQ: ARWR) Discloses on Its August 4 Fiscal Q2 2026 Conference Call the Full Terms of the Priority Review Voucher (PRV) Acquisition: $215 Million Paid to an Undisclosed Seller Under an Asset Purchase Agreement Expected to Close in Fiscal Q4 2026, Applied to the Plozasiran (Redemplo, ApoC-III-Targeting siRNA) Supplemental New Drug Application (sNDA) for Severe Hypertriglyceridemia (sHTG) Planned Before End of 2026 Following the July 23, 2026 Phase 3 SHASTA-3 and SHASTA-4 Positive Readouts (79-81% Median Triglyceride Reduction, Significant Pancreatitis-Event Reduction); Arrowhead Projects a 3x Return on the $215 Million PRV Investment by Shifting the Plozasiran sHTG Uptake Curve Forward by Approximately Four Months (FDA Review Timeline Compressed From Standard 10 Months to 6 Months)

Arrowhead Pharmaceuticals (NASDAQ: ARWR) disclosed the full terms of its Priority Review Voucher (PRV) acquisition first mentioned on the August 4, 2026 fiscal Q2 2026 conference call. Terms: $215 million paid to an undisclosed seller under an asset purchase agreement expected to close in fiscal Q4 2026. Applied to: the plozasiran (Redemplo) supplemental new drug application (sNDA) for severe hypertriglyceridemia (sHTG), planned for submission before end of 2026 following the July 23, 2026 Phase 3 SHASTA-3 and SHASTA-4 positive readouts (79% SHASTA-3 and 81% SHASTA-4 median triglyceride reductions at Month 12 versus approximately 27% for placebo, plus statistically significant reductions in acute pancreatitis events). Return projection: Arrowhead management projects a 3x return on the $215 million PRV investment by shifting the plozasiran sHTG commercial uptake curve forward by approximately four months (the PRV compresses FDA new drug application review from the standard 10-month timeline to a 6-month priority review timeline). PRVs are transferable FDA-issued regulatory instruments awarded to sponsors that develop drugs for rare pediatric diseases, tropical diseases, or specific medical countermeasures; recent secondary-market transactions have priced PRVs in the $100-250 million range depending on demand and pipeline urgency. Redemplo (plozasiran) was FDA-approved November 2025 for familial chylomicronemia syndrome; the sHTG indication would substantially expand the addressable patient population.

Regulatory · View digest

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.