Plozasiran Development Progress
Full enrollment achieved in SHASTA-3, SHASTA-4, and MUIR-3 Phase III studies for plozasiran, with completion expected by mid-2026. Market authorization applications for FCS are progressing, with a U.S. PDUFA date set for November 18, 2025.
Zodasiran Phase III Initiation
YOSEMITE Phase III study for zodasiran as a treatment for HoFH initiated, with the first patient enrolled. The study targets 60 subjects over 12 months to assess LDL-cholesterol reduction.
Visirna Therapeutics Deal with Sanofi
Sanofi to acquire rights to plozasiran in Greater China, providing $130 million upfront and up to $265 million in milestone payments. Arrowhead retains a 56% ownership in Visirna.
Strong Financial Position
Cash and investments totaled $900.4 million as of June 30, 2025. Upcoming $100 million milestone payment from Sarepta expected to further bolster financials.
Broad Pipeline and Strategic Initiatives
Arrowhead is on track with its '20 in 25' initiative, aiming to have 20 drug candidates in clinical studies or at market by the end of 2025. The company is focused on expanding its cardiometabolic and CNS franchises.