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Arrowhead Gains FDA Approval for Redemplo as Results Surge and Shares Hit Three-Year High

The company plans to begin U.S. sales before year‑end for its siRNA therapy addressing severe familial chylomicronemia syndrome.

Overview

  • The FDA approved Redemplo for adults with familial chylomicronemia syndrome, the first and only approved siRNA medicine to reduce triglycerides in this population.
  • Arrowhead reported fiscal-year revenue of $829.4 million, up from $3.5 million a year earlier, with its attributable net loss narrowing to $1.63 million from $599.49 million.
  • Shares climbed to a three-year intraday high of $59.15 and closed up about 23% at $57.71 following the approval and earnings update.
  • Arrowhead said it is targeting the start of Redemplo sales in the U.S. before the end of the year.
  • FCS affects as many as 6,500 people in the U.S. and is marked by triglyceride levels far above normal and a heightened risk of acute, recurrent pancreatitis.