modzatinib (ATI-2138)

August 6, 2026: Aclaris Therapeutics (NASDAQ: ACRS) said the FDA granted Fast Track designation to modzatinib (ATI-2138) for moderate to severe lichen planus, including oral erosive lichen planus, cutaneous lichen planus, and lichen planopilaris. The company said there are currently no approved therapies for this disease.

The catalyst is a regulatory designation intended to expedite development and review; the release notes Fast Track can enable more frequent FDA interactions, rolling NDA review, and possible Priority Review eligibility if criteria are met.

Aclaris also said it expects to start a phased multi-part Phase 2b trial of modzatinib in lichen planus in Q4 2026. The release does not provide clinical efficacy or safety data.