Aclaris Initiates Phase 1b Trial of ATI-052 for Asthma
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Feb 24 2026
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Should l Buy ACRS?
Aclaris Therapeutics has initiated a placebo-controlled Phase 1b proof-of-concept trial of ATI-052, the Company's potential best-in-class investigational bispecific anti-TSLP/IL-4Ralpha antibody, in asthma. This announcement follows the recent initiation of the Company's Phase 1b POC trial of ATI-052 in atopic dermatitis. Planning is ongoing for a Phase 2b program encompassing asthma and atopic dermatitis as potential first indications. The Company expects to initiate this program in the second half of 2026. The randomized, double-blind, placebo-controlled Phase 1b POC trial will evaluate the safety, tolerability, and efficacy of ATI-052 compared to placebo in approximately 16 patients with asthma on GINA steps 2-4 treatment prior to screening. Endpoints that will be assessed include safety and tolerability parameters; pharmacokinetic parameters; respiratory pharmacodynamic biomarker assessments including FeNO; blood PD biomarker assessments including blood eosinophil count and endogenous cytokines/chemokines and inflammation markers in plasma/serum; and efficacy measures including FEV1. Top line results from this trial and the ongoing Phase 1b POC trial in AD are expected in the second half of 2026.
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Analyst Views on ACRS
Wall Street analysts forecast ACRS stock price to rise
3 Analyst Rating
3 Buy
0 Hold
0 Sell
Strong Buy
Current: 3.490
Low
8.00
Averages
11.33
High
16.00
Current: 3.490
Low
8.00
Averages
11.33
High
16.00
About ACRS
Aclaris Therapeutics, Inc. is a clinical-stage biopharmaceutical company. The Company is engaged in developing a pipeline of drug candidates to address the needs of patients with immuno-inflammatory diseases. It has a multi-stage portfolio of drug candidates powered by a robust research and development engine. Its KINect drug discovery platform, combined with its preclinical development capabilities, allows it to identify and advance potential product candidates that it may develop independently or in collaboration with third parties. It has two segments: therapeutics and contract research. The therapeutics segment is focused on identifying and developing therapies to address unmet needs for immuno-inflammatory diseases. The contract research segment is engaged in the provision of laboratory services. Its drug candidates include Bosakitug (ATI-045), ATI-2138 and ATI-052. Its other investigational product candidates include Lepzacitinib (ATI-1777) and Zunsemetinib (ATI-450).
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Aclaris Reports Significant Clinical Results for ATI-2138 in Atopic Dermatitis
- Significant Clinical Outcomes: At the 2026 American Academy of Dermatology Annual Meeting, Aclaris reported that patients receiving ATI-2138 showed a 77% improvement in Eczema Area and Severity Index (EASI) scores over 12 weeks, highlighting the drug's potential in treating atopic dermatitis.
- Multiple Metrics Improvement: The treatment group experienced a 70% improvement in affected body surface area, a 50% reduction in Peak Pruritus Numerical Rating Scale (PP-NRS) scores, and a 65% enhancement in Dermatology Life Quality Index (DLQI), further validating ATI-2138's broad applicability in immuno-inflammatory diseases.
- Good Tolerability: ATI-2138 demonstrated excellent tolerability at a low dose of 10 mg BID, achieving near-complete ITK target occupancy, which may reduce drug burden and enhance dosing flexibility for patients.
- Research and Development Potential: Aclaris's pipeline indicates that ATI-2138 is not only effective in atopic dermatitis but also holds promise for other immune-inflammatory diseases reliant on T cell function, supporting its potential as a best-in-class therapy.
See More
Aclaris Q4 Earnings Miss Expectations with Significant Revenue Decline
- Disappointing Earnings: Aclaris Therapeutics reported a Q4 GAAP EPS of -$0.16, missing expectations by $0.02, indicating ongoing pressure on profitability that may affect investor confidence.
- Significant Revenue Decline: The company generated $1.3 million in revenue, an 85.9% year-over-year drop, falling short of the expected $0.77 million, reflecting weak market demand and sales challenges that could strain future cash flow.
- Decreased Cash Reserves: As of December 31, 2025, Aclaris had cash, cash equivalents, and marketable securities totaling $151.4 million, down from $203.9 million in 2024, highlighting pressures on operational and R&D expenditures.
- Clinical Trial Progress: Despite poor financial results, Aclaris reported positive interim results from the ATI-052 Phase 1a trial, potentially laying the groundwork for future therapeutic advantages and demonstrating the company's R&D potential.
See More
Aclaris ATI-2138 Shows Superior Efficacy in Hair Loss Treatment
- Preclinical Results: Aclaris Therapeutics' ATI-2138 demonstrated rapid and near-complete hair regrowth in a murine model, achieving 87% regrowth at week 4 compared to Pfizer's Litfulo at 48%, indicating a significant therapeutic advantage in treating autoimmune alopecia.
- Future Trial Plans: Aclaris is set to initiate a Phase 2b trial for ATI-2138 in the first half of 2026, exploring its potential for additional alopecia indications, reflecting the company's confidence in the drug's market prospects.
- Strong Stock Performance: ACRS shares are trading at $3.88, 22.6% above the 20-day simple moving average and have increased by 58.16% over the past year, showcasing robust short-term and medium-term momentum that suggests investor optimism about the company's future.
- Analyst Ratings: The stock carries a 'Buy' rating with an average price target of $10.73, while HC Wainwright & Co. maintains a target of $16, indicating strong market recognition of Aclaris' growth potential.
See More
Aclaris Therapeutics Added to Nasdaq Biotechnology Index Effective December 19, 2025
- Index Inclusion: Aclaris Therapeutics has been added to the Nasdaq Biotechnology Index effective December 19, 2025, marking a significant recognition in the biopharmaceutical sector that enhances its market image and investor confidence.
- Market Standards: The Nasdaq Biotechnology Index aims to track the performance of securities classified as biotechnology or pharmaceutical, and Aclaris's inclusion indicates it meets various eligibility criteria, including minimum market capitalization and average daily trading volume, thereby strengthening its competitive position in the industry.
- Annual Evaluation: The index is evaluated annually in December using a modified capitalization-weighted methodology, and Aclaris's addition may attract more investor attention, potentially improving its stock liquidity and market performance.
- R&D Potential: As a clinical-stage biopharmaceutical company focused on immuno-inflammatory diseases, Aclaris's inclusion not only elevates its industry standing but may also bring additional funding support for its R&D pipeline, aiding in the development of new products to meet patient needs.
See More
Aclaris Therapeutics Added to Nasdaq Biotechnology Index
- Inclusion in Index: Aclaris Therapeutics (ACRS) has been added to the Nasdaq Biotechnology Index.
- Announcement Timing: The announcement regarding the inclusion was made late Friday.
See More
Aclaris Therapeutics Added to Nasdaq Biotechnology Index Effective December 19, 2025
- Index Inclusion: Aclaris Therapeutics was added to the Nasdaq Biotechnology Index at the close of trading on December 19, 2025, marking a significant recognition in the biopharmaceutical sector that enhances its market image and investor confidence.
- Market Standards: The Nasdaq Biotechnology Index requires companies to meet minimum market capitalization and average daily trading volume standards, and Aclaris's inclusion reflects its stability and growth potential in the biopharmaceutical industry.
- R&D Strength: Aclaris focuses on developing novel product candidates for immuno-inflammatory diseases, boasting a multi-stage product pipeline that underscores its ongoing commitment to addressing patient needs.
- Investor Attention: Inclusion in the index may attract more institutional investors, potentially driving up the company's stock price and strengthening its competitive position in the biopharmaceutical market.
See More
Aclaris Reports Significant Clinical Results for ATI-2138 in Atopic Dermatitis
- Significant Clinical Outcomes: At the 2026 American Academy of Dermatology Annual Meeting, Aclaris reported that patients receiving ATI-2138 showed a 77% improvement in Eczema Area and Severity Index (EASI) scores over 12 weeks, highlighting the drug's potential in treating atopic dermatitis.
- Multiple Metrics Improvement: The treatment group experienced a 70% improvement in affected body surface area, a 50% reduction in Peak Pruritus Numerical Rating Scale (PP-NRS) scores, and a 65% enhancement in Dermatology Life Quality Index (DLQI), further validating ATI-2138's broad applicability in immuno-inflammatory diseases.
- Good Tolerability: ATI-2138 demonstrated excellent tolerability at a low dose of 10 mg BID, achieving near-complete ITK target occupancy, which may reduce drug burden and enhance dosing flexibility for patients.
- Research and Development Potential: Aclaris's pipeline indicates that ATI-2138 is not only effective in atopic dermatitis but also holds promise for other immune-inflammatory diseases reliant on T cell function, supporting its potential as a best-in-class therapy.
See More
Aclaris Q4 Earnings Miss Expectations with Significant Revenue Decline
- Disappointing Earnings: Aclaris Therapeutics reported a Q4 GAAP EPS of -$0.16, missing expectations by $0.02, indicating ongoing pressure on profitability that may affect investor confidence.
- Significant Revenue Decline: The company generated $1.3 million in revenue, an 85.9% year-over-year drop, falling short of the expected $0.77 million, reflecting weak market demand and sales challenges that could strain future cash flow.
- Decreased Cash Reserves: As of December 31, 2025, Aclaris had cash, cash equivalents, and marketable securities totaling $151.4 million, down from $203.9 million in 2024, highlighting pressures on operational and R&D expenditures.
- Clinical Trial Progress: Despite poor financial results, Aclaris reported positive interim results from the ATI-052 Phase 1a trial, potentially laying the groundwork for future therapeutic advantages and demonstrating the company's R&D potential.
See More
Aclaris ATI-2138 Shows Superior Efficacy in Hair Loss Treatment
- Preclinical Results: Aclaris Therapeutics' ATI-2138 demonstrated rapid and near-complete hair regrowth in a murine model, achieving 87% regrowth at week 4 compared to Pfizer's Litfulo at 48%, indicating a significant therapeutic advantage in treating autoimmune alopecia.
- Future Trial Plans: Aclaris is set to initiate a Phase 2b trial for ATI-2138 in the first half of 2026, exploring its potential for additional alopecia indications, reflecting the company's confidence in the drug's market prospects.
- Strong Stock Performance: ACRS shares are trading at $3.88, 22.6% above the 20-day simple moving average and have increased by 58.16% over the past year, showcasing robust short-term and medium-term momentum that suggests investor optimism about the company's future.
- Analyst Ratings: The stock carries a 'Buy' rating with an average price target of $10.73, while HC Wainwright & Co. maintains a target of $16, indicating strong market recognition of Aclaris' growth potential.
See More
Aclaris Therapeutics Added to Nasdaq Biotechnology Index Effective December 19, 2025
- Index Inclusion: Aclaris Therapeutics has been added to the Nasdaq Biotechnology Index effective December 19, 2025, marking a significant recognition in the biopharmaceutical sector that enhances its market image and investor confidence.
- Market Standards: The Nasdaq Biotechnology Index aims to track the performance of securities classified as biotechnology or pharmaceutical, and Aclaris's inclusion indicates it meets various eligibility criteria, including minimum market capitalization and average daily trading volume, thereby strengthening its competitive position in the industry.
- Annual Evaluation: The index is evaluated annually in December using a modified capitalization-weighted methodology, and Aclaris's addition may attract more investor attention, potentially improving its stock liquidity and market performance.
- R&D Potential: As a clinical-stage biopharmaceutical company focused on immuno-inflammatory diseases, Aclaris's inclusion not only elevates its industry standing but may also bring additional funding support for its R&D pipeline, aiding in the development of new products to meet patient needs.
See More
Aclaris Therapeutics Added to Nasdaq Biotechnology Index
- Inclusion in Index: Aclaris Therapeutics (ACRS) has been added to the Nasdaq Biotechnology Index.
- Announcement Timing: The announcement regarding the inclusion was made late Friday.
See More
Aclaris Therapeutics Added to Nasdaq Biotechnology Index Effective December 19, 2025
- Index Inclusion: Aclaris Therapeutics was added to the Nasdaq Biotechnology Index at the close of trading on December 19, 2025, marking a significant recognition in the biopharmaceutical sector that enhances its market image and investor confidence.
- Market Standards: The Nasdaq Biotechnology Index requires companies to meet minimum market capitalization and average daily trading volume standards, and Aclaris's inclusion reflects its stability and growth potential in the biopharmaceutical industry.
- R&D Strength: Aclaris focuses on developing novel product candidates for immuno-inflammatory diseases, boasting a multi-stage product pipeline that underscores its ongoing commitment to addressing patient needs.
- Investor Attention: Inclusion in the index may attract more institutional investors, potentially driving up the company's stock price and strengthening its competitive position in the biopharmaceutical market.
See More
