An FDA approval later this year for Arrowhead’s plozasiran in FCS would put it in direct competition with Ionis’ Tryngolza.

Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that the U.S. Food and Drug Administration (FDA) has accepted ...

Pharmaceuticals announced that the U.S. FDA has accepted the New Drug Application for investigational plozasiran for the ...

In FCS, mutations in the lipoprotein lipase gene lead to an accumulation of chylomicrons in plasma resulting in severe hypertriglyceridemia.

Arrowhead Pharmaceuticals (NASDAQ:ARWR) said the FDA has accepted its New Drug Application for its drug plozasiran for the ...

Arrowhead Pharmaceuticals said Friday that the Food and Drug Administration accepted the company's new drug application for its treatment of familial chylomicronemia syndrome, a severe and rare ...

In 2024, there were numerous trials and a few regulatory moves related to advancements in lipid management for the prevention ...

The most significant recent development for Arrowhead is the submission of a New Drug Application (NDA) for plozasiran, an RNAi therapeutic designed to treat familial chylomicronemia syndrome (FCS).

The reliance of Arrowhead Pharmaceuticals, Inc. on Vanscoy Rare Pharmacy for the distribution of plozasiran presents a significant business risk, as any financial instability or altered buying ...

Based on the “compelling” Phase 3 trial data generated from Arrowhead’s plozasiran, an RNA interference therapeutic targeting apolipoprotein C-III in familial chylomicronemia syndrome ...

Earlier this month, we submitted our first NDA to the U.S. FDA for investigational plozasiran, paving the way for Arrowhead to potentially launch our first commercial product in 2025, subject to ...

Arrowhead said it intends to investigate plozasiran as a treatment for other diseases on that spectrum, including severe hypertriglyceridemia and mixed hyperlipidemia.