Aclaris Therapeutics, Inc. (ACRS) News & EventsACRSNews & EventsAclaris Therapeutics, Inc.

Aclaris Receives FDA Fast Track Designation for Moderate to Severe Lichen Planus

Aclaris Therapeutics announced that the U.S. Food and Drug Administration has granted Fast Track Designation for modzatinib for moderate to severe lichen planus 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 the fourth quarter of 2026. Fast Track designation is intended to facilitate the development and expedite the review of investigational therapies that treat serious conditions and fill an unmet medical need. The designation provides for more frequent interactions with the FDA regarding the development plan and clinical trial design, supporting a potentially more efficient path to registration. Fast Track designation also allows for rolling review of a New Drug Application (NDA), meaning completed sections may be submitted and reviewed on an ongoing basis rather than waiting until every section of the NDA is completed before the entire application can be reviewed. "Lichen planus is a serious, clinically concerning disease with debilitating symptoms that can affect the quality of life of patients suffering from this disorder; unfortunately, there are currently no approved therapies," said Dr. Jesse Hall, Chief Medical Officer of Aclaris "This is an important milestone for our company; we look forward to more frequent interactions with the FDA as we move modzatinib into a Phase 2b trial later this year."

Aclaris Therapeutics Files Automatic Mixed Securities Shelf

Aclaris Therapeutics files automatic mixed securities shelf

Aclaris Q2 Revenue of $1.6M Exceeds Expectations

Reports Q2 revenue $1.6M, consensus $1.38M. As of June 30, Aclaris had cash, cash equivalents and marketable securities of $170.6M vs. $151.4M as of December 31, 2025. The company believes that its cash, cash equivalents and marketable securities will be sufficient to fund its operations through the end of 2028, without giving effect to any potential business development transactions or additional financing activities. "The first half of 2026 was a period of strong execution across the organization, positioning Aclaris for an exciting second half of the year with numerous expected key catalysts," stated CEO Neal Walker. "We expect to provide three clinical data readouts, including placebo-controlled top line results from our two Phase 1b POC trials of our anti-TSLP/IL-4Ralpha bispecific antibody ATI-052 in both asthma and atopic dermatitis and the Phase 2 AD trial of our anti-TSLP monoclonal antibody bosakitug. Other key catalysts include initiation of a Phase 2b clinical program with ATI-052 and a Phase 2b trial in lichen planus with modzatinib. Finally, our data presented recently at the FASEB Immunoreceptors and Immunotherapy conference support the best-in-class potential of our investigational ITK inhibitor ATI-9494, for which we expect to file an IND late this year."