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WAYNE, Pa. - Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a $168 million market cap biotech company currently trading at $1.55, announced positive top-line results from its Phase 2a trial of ATI-2138, an oral inhibitor targeting interleukin-2-inducible T cell kinase (ITK) and Janus kinase 3 (JAK3), in patients with moderate-to-severe atopic dermatitis. According to InvestingPro analysis, the stock appears undervalued based on its Fair Value metrics, with analysts setting price targets ranging from $2 to $16.
The open-label, single-arm trial evaluated 14 patients who received 10mg of ATI-2138 twice daily for 12 weeks. According to the company’s press release statement, the study met its primary safety endpoint, with ATI-2138 demonstrating a favorable tolerability profile with no severe adverse events or treatment-emergent adverse events reported. InvestingPro data shows the company maintains strong liquidity with a current ratio of 5.06, though it reported an EBITDA of -$54 million in the last twelve months.
Efficacy results showed that patients experienced a mean improvement of 60.5% in the Eczema Area and Severity Index (EASI) score at week 12, with a median improvement of 76.8%. Additionally, 62.5% of patients achieved a clinically meaningful reduction in itch intensity, defined as a four-point or greater improvement on the Peak Pruritus Numerical Rating Scale.
The drug demonstrated significant pharmacodynamic effects, with near-complete ITK target occupancy observed across the dosing interval. Analyses of skin samples showed downregulation of inflammatory markers associated with ITK pathways.
"The objectives of this trial were to confirm the strong tolerability profile across multiple doses of ATI-2138 over 12 weeks, to test the mechanism in AD before initiating our work in other diseases including alopecia areata, and to further validate ITK as an important therapeutic target," said Dr. Neal Walker, Chief Executive Officer of Aclaris.
Based on these results, Aclaris plans to further develop ATI-2138 for alopecia areata while exploring other potential indications. The company is also advancing preclinical work on next-generation ITK inhibitors, with expectations for new investigational new drug applications beginning in 2026. With the company’s next earnings report due on August 6, investors can access detailed financial analysis and 8 additional key insights through InvestingPro’s comprehensive research reports, available for over 1,400 US stocks.
The trial included 10 patients in the per protocol analysis, with demographics split evenly between male and female participants, and half self-identifying as African American.
In other recent news, Aclaris Therapeutics has been added to the Russell 3000 and Russell 2000 indexes as part of the 2025 Russell US Indexes annual reconstitution. This inclusion will last for one year. Aclaris has also started a Phase 2 trial for its atopic dermatitis drug, bosakitug, following promising results from a Phase 2a study. The trial will involve about 90 patients and will focus on measuring changes in the Eczema Area and Severity Index (EASI) over 24 weeks.
Analyst firm H.C. Wainwright has maintained its Buy rating on Aclaris stock, setting a price target of $16, citing strong results from bosakitug’s clinical studies. Meanwhile, Wedbush initiated coverage with an Outperform rating and a price target of $8, highlighting Aclaris’s focus on developing treatments for immunology and inflammation. The company is also advancing its lead small molecule, ATI-2138, with expected Phase 2 trial results in June 2025. These developments underscore Aclaris’s ongoing efforts in advancing its drug pipeline.
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