USFDAAug 6, 2026, 04:37 PM
Aclaris Therapeutics' Modzatinib Gets FDA Fast Track Designation
AI Summary
Aclaris Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for modzatinib (ATI-2138) for moderate to severe lichen planus (LP). This designation covers oral erosive LP, cutaneous LP, and lichen planopilaris, conditions for which there are currently no approved therapies. The company plans to initiate a phased multi-part Phase 2b trial of modzatinib in LP in the fourth quarter of 2026, benefiting from the expedited review process and increased FDA interaction provided by the Fast Track status.
Key Highlights
- Modzatinib (ATI-2138) received FDA Fast Track Designation.
- Designation is for moderate to severe lichen planus (LP), including oral erosive LP, cutaneous LP, and lichen planopilaris.
- Aclaris expects to initiate a phased multi-part Phase 2b trial of modzatinib in LP in Q4 2026.
- Fast Track designation facilitates development and expedites review of investigational therapies.
- The designation allows for more frequent interactions with the FDA and potential rolling review of an NDA.
- There are currently no approved therapies for lichen planus.
Price Impact
More from ACRS