Benzinga | Aug 9, 2021 10:57AM EDT

Calliditas' Chronic Orphan Liver Disease Candidate Receives FDA Fast Track Tag

* The FDA has granted Fast Track Designation to Calliditas Therapeutics AB's (NASDAQ:CALT) lead NOX inhibitor candidate setanaxib for primary biliary cholangitis (PBC).

* Setanaxib has previously been granted orphan drug designation for PBC in the US and Europe.

* In the Phase 2 trial, setanaxib demonstrated evidence of anti-fibrotic activity, combined with a favorable tolerability profile, as well as a statistically significant impact on fatigue.

* Calliditas is planning to initiate a pivotal Phase 2/3 study in PBC, starting in 2H 2021.

* Price Action: CALT shares traded higher by 1.37% at $29.65 on the last check Monday.

* Related content: Benzinga's Full FDA Calendar.