Aclaris Therapeutics Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on immuno-inflammatory diseases, has released new preclinical data showing strong efficacy of its investigational drug ATI-2138 in a murine model of severe alopecia areata (AA), an autoimmune condition that causes hair loss.
In the study, ATI-2138 demonstrated rapid, near-complete, and sustained hair regrowth, outperforming Pfizer Inc.’s (NYSE: PFE) approved therapy Litfulo (ritlecitinib). Alopecia areata typically presents as patchy hair loss but can progress to alopecia universalis, the most severe form of the disease.
The preclinical evaluation used a reversal model of murine alopecia universalis, in which hair loss was first established before treatment began. Mice were randomized to receive either control chow or chow formulated with ATI-2138 at doses of 100 or 300 parts per million (ppm), or ritlecitinib at 300 ppm. Hair regrowth was measured at baseline and at weeks two, four, and six.
Results showed a rapid onset of hair regrowth in mice treated with 300 ppm ATI-2138, with an average of 37% regrowth observed by week two. By week four, regrowth reached 87%, compared with 25% and 48%, respectively, in the ritlecitinib group. By week six, mice receiving ATI-2138 achieved a mean hair regrowth of 93%, exceeding the 78% observed in mice treated with ritlecitinib. Animals receiving control chow showed no measurable improvement throughout the study.
Aclaris said it is evaluating additional potential indications for ATI-2138, including other forms of alopecia, and plans to initiate a Phase 2b clinical trial in the first half of 2026.
The company has previously reported encouraging clinical data for ATI-2138. In July 2025, Aclaris announced positive top-line results from an open-label Phase 2a trial involving 14 patients with moderate-to-severe atopic dermatitis. That study met its primary and key secondary endpoints and confirmed a favorable tolerability profile for the drug candidate.
Aclaris shares have shown notable momentum in recent trading. The stock is trading approximately 22.6% above its 20-day simple moving average and 53.7% above its 100-day average. Over the past 12 months, shares have gained more than 58%, placing the stock closer to its 52-week highs.
Technical indicators show mixed but generally positive signals. The relative strength index (RSI) stands at 60.43, indicating neutral conditions, while the moving average convergence divergence (MACD) remains above its signal line, suggesting bullish momentum. Key resistance is identified at $4.50, with support around $3.00.
Analysts currently maintain a bullish outlook on the stock, assigning a consensus Buy rating and an average price target of $10.73. HC Wainwright & Co. recently reiterated its Buy rating with a $16 price target.
According to Benzinga Pro data, Aclaris Therapeutics shares were up 1.44% at $3.88 at the time of publication.
