Arrowhead Targets U.S. REDEMPLO Launch for Q2 2027, Subject to FDA Approval

Arrowhead Pharmaceuticals is targeting a potential U.S. launch of REDEMPLO for severe hypertriglyceridemia in the second quarter of 2027, with FDA review and approval still required before the treatment can launch.

The FDA’s STAR pilot provides a six-month priority review framework for the application. Arrowhead reiterated a $3 billion to $4 billion U.S. sales opportunity for REDEMPLO, but said it is too early to provide sales guidance.

In a commercial update, Arrowhead said new-to-brand prescriptions rose 63% from the prior quarter-end and payer formularies covered more than 160 million U.S. lives. Arrowhead Chairman, CEO and President Dr. Christopher Anzalone said, “Simply put, commercial progress with REDEMPLO is critical.”

Arrowhead’s fiscal 2026 results included revenue of $450.82 million and a GAAP loss of $5.11 per share, as detailed in its fiscal year-end results.