Arrowhead’s ARO-AAT Fast Track’d for liver disease

The FDA has granted Fast Track designation to Arrowhead Pharmaceuticals’ (NASDAQ:ARWR) ARO-AAT, the RNA interference (RNAi) therapeutic developed as a treatment for a rare genetic liver disease associated with alpha-1 antitrypsin deficiency (AATD).

Arrowhead will initiate SEQUOIA (AROAAT2001), a Phase 2/3 clinical study in the U.S. and Europe, and AROAAT2002, a Phase 2 open-label clinical study in Europe.

The Fast Track designation provides for more frequent interactions with the FDA review team and a rolling review of the NDA.

Shares are up 2% premarket.

https://seekingalpha.com/news/3474235-arrowheads-aro-aat-fast-trackd-liver-disease