Arrowhead Pharmaceuticals received U.S. Food and Drug Administration approval for its lead RNA interference (RNAi) therapy, REDEMPLO (plozasiran), on November 18 2025. The approval authorizes REDEMPLO as an adjunct to diet for reducing triglycerides in adults with familial chylomicronemia syndrome (FCS), a rare genetic disorder that affects roughly 6,500 people in the United States.
The approval was based on the Phase 3 PALISADE study, which demonstrated a median 80 % reduction in triglyceride levels in patients receiving REDEMPLO compared with a 17 % reduction in the placebo group. The study also reported a lower incidence of acute pancreatitis in the treatment arm, underscoring the drug’s clinical benefit in a population that historically has limited therapeutic options.
REDEMPLO’s clinical profile gives it a competitive edge over Ionis Pharmaceuticals’ existing FCS therapy, Tryngolza. In addition to a more convenient quarterly at‑home dosing schedule, Arrowhead’s pricing strategy positions REDEMPLO at a significantly lower cost than Tryngolza, potentially expanding access for patients and improving market penetration.
Arrowhead’s balance sheet has been strengthened by recent financing activities. The company secured a $500 million senior secured credit facility with Sixth Street and received milestone payments of $50 million from Royalty Pharma and $130 million from Sanofi for Greater China rights. These inflows, combined with a robust cash position, give Arrowhead a runway of more than three years to support commercial launch and ongoing pipeline development.
CEO Christopher Anzalone described the approval as a “transformational milestone” that marks Arrowhead’s transition from a development‑stage company to a commercial‑stage organization. He emphasized that the company’s RNAi platform has matured, with four candidates in pivotal Phase 3 studies, and that the commercial buildout is ready to support a day‑one launch of REDEMPLO.
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