Aclaris wins FDA fast-track status for modzatinib in moderate-to-severe lichen planus, eyes Phase 2b start in Q4 2026
ACRS•FDA Fast Track designation granted
Aclaris Therapeutics received FDA Fast Track designation for modzatinib (ATI-2138) in moderate to severe lichen planus.
No clinical results were presented; a phased multi-part Phase 2b trial is slated to start in Q4 2026.
Development path and pipeline impact
The designation supports an accelerated development path, with more frequent FDA engagement and potential rolling NDA review.
The move strengthens Aclaris’s positioning in a disease area with no approved therapies, expanding its immuno-inflammatory pipeline optionality.
