Aclaris wins FDA fast-track status for modzatinib in moderate-to-severe lichen planus, eyes Phase 2b start in Q4 2026

Reuters2026/08/06 22:08

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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.
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.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Aclaris Therapeutics Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 202608061635PRIMZONEFULLFEED9805485) on August 06, 2026, and is solely responsible for the information contained therein.

Disclaimer: The content of this article solely reflects the author's opinion and does not represent the platform in any capacity. This article is not intended to serve as a reference for making investment decisions.

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Aclaris wins FDA fast-track status for modzatinib in moderate-to-severe lichen planus, eyes Phase 2b start in Q4 2026

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