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

by Vandana Singh, Benzinga Editor

August 9, 2021 10:57 AM | 1 min read |

The FDA has granted Fast Track Designation to Calliditas Therapeutics AB's 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.