Arrowhead Pharmaceuticals (ARWR) said Monday that it submitted a new drug application to the US Food and Drug Administration for its experimental drug, plozasiran, to treat familial chylomicronemia syndrome, a rare disease that could lead to potentially fatal pancreatitis.
The company said the application is supported by data from a phase 3 study that met primary and key secondary endpoints, including reductions in triglycerides and the incidence of acute pancreatitis.
The drugmaker also said it plans to seek approval for plozasiran from other regulatory authorities in 2025.
Shares of the company were up more than 3% in recent premarket activity.
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