ACRS

WAYNE, Pa. (AP) — WAYNE, Pa. (AP) — Aclaris Therapeutics Inc. (ACRS) on Thursday reported a loss of $19.8 million in its first quarter. On a per-share basis, the Wayne, Pennsylvania-based company said it had a loss of 15 cents. The results topped Wall Street expectations. The average estimate of six analysts surveyed by Zacks Investment Research was for a loss of 16 cents per share. The specialty pharmaceutical company posted revenue of $2 million in the period, also surpassing Street forecasts. Six analysts surveyed by Zacks expected $1.4 million. The company's shares closed at $4.80. A year ago, they were trading at $1.28. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on ACRS at https://www.zacks.com/ap/ACRS

- Full Top Line Results from Phase 1a SAD/MAD Trial of ATI-052 Exceed Aclaris’ Target Profile, Validating Potential Best-in-Class Potency Advantage and Opportunity for Extended Dosing - - Unique Dual Mechanism of ATI-2138 Supports Planned Phase 2b Clinical Trial in Lichen Planus - - Strong Cash Runway Expected to Enable Development of Pipeline Through 2028 - WAYNE, Pa., May 07, 2026 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel product candidates for immuno-inflammatory diseases, today announced its financial results for the first quarter of 2026 and provided a corporate and clinical update. “Since the start of 2026, we have made great progress toward our goal of developing best-in-class compounds to address a variety of immuno-inflammatory diseases,” stated Dr. Neal Walker, Chief Executive Officer and Chair of the Board of Directors of Aclaris. “Most recently, the positive results from our Phase 1a SAD/MAD trial of our bispecific antibody ATI-052 confirmed its potential as having a best-in-class PK/PD profile with an extended dosing schedule of up to every three months. We look forward to an exciting rest of the year with expected milestones including delivery of placebo-controlled top line results from our Phase 1b proof-of-concept trials of ATI-052 in both asthma and atopic dermatitis and the Phase 2 trial of our anti-TSLP monoclonal antibody bosakitug in atopic dermatitis.” First Quarter 2026 Highlights and Recent Updates Pipeline: Biologics: Antibody Franchise Provided Positive Full Top Line Results of Phase 1a Single (SAD) and Multiple Ascending Dose (MAD) Trial of Investigational Bispecific Anti-TSLP/IL-4Rα Antibody ATI-052 Confirming Potency and Potential for Extended Dosing: ATI-052 exhibited a potential best-in-class pharmacokinetic (PK) profile, including an estimated half-life of approximately 45 days. The pharmacodynamic (PD) results validate the potency of ATI-052, including robust target engagement demonstrated by complete and sustained inhibition through at least week 20 of ex vivo TSLP stimulated CCL17 (TARC) and at least week 12 of ex vivo IL-4 stimulated CCL17 in the 480 mg MAD cohort. The combination of the strong and sustained PK duration and PD effect supports the potential for up to every three-month dosing. ATI-052 was well tolerated and demonstrat...

Rigel Pharmaceuticals (RIGL) came out with quarterly earnings of $0.44 per share, missing the Zacks Consensus Estimate of $0.74 per share. This compares to earnings of $0.63 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of -40.54%. A quarter ago, it was expected that this drug developer would post earnings of $1.33 per share when it actually produced earnings of $1.14, delivering a surprise of -14.29%. Over the last four quarters, the company has surpassed consensus EPS estimates two times. Rigel, which belongs to the Zacks Medical - Drugs industry, posted revenues of $58.82 million for the quarter ended March 2026, missing the Zacks Consensus Estimate by 2.39%. This compares to year-ago revenues of $53.33 million. The company has topped consensus revenue estimates two times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Rigel shares have lost about 31% since the beginning of the year versus the S&P 500's gain of 5.2%. While Rigel has underperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Rigel was unfavorable. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #4 (Sell) for the stock. So, the shares are expected to underperform the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It will...

- Positive Full Results from Phase 1a Trial of Anti-TSLP/IL-4Rα Bispecific Antibody ATI-052 Exceed Aclaris’ Target Profile, Validating Potential Best-in-Class Potency Advantage and Opportunity for Extended Dosing - - Estimated Half-Life of Approximately 45 Days; Unlocks Opportunity for up to Three-Month Dosing Interval - - Complete and Sustained Inhibition of TSLP-Induced and IL-4 Induced CCL17 (TARC) Provides Potential to Raise Efficacy Ceiling in Th2-Driven Diseases - - Enrollment and Dosing Ongoing in Phase 1b Trials in Asthma and Atopic Dermatitis (AD) with Top Line Results Expected in the Second Half of 2026 - - Lichen Planus Selected as Lead Indication for ATI-2138; Potential to be First Mechanistically Complete Therapeutic Candidate Designed to Address Root Inflammation and Symptoms - - Management to Host a Conference Call to Discuss Update Today at 8:30 AM EST - WAYNE, Pa., April 28, 2026 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel product candidates for immuno-inflammatory diseases, today provided a clinical update on its biologic and oral inhibitor compounds including positive full top line results from the first-in-human Phase 1a single (SAD) and multiple ascending dose (MAD) trial of its anti-TSLP/IL-4Rα bispecific antibody ATI-052 and the selection of lichen planus (LP) as the lead indication for its selective ITK/JAK3 inhibitor ATI-2138. “These results validate that ATI-052 is a highly potent and well tolerated bispecific antibody that has the potential to be highly effective in a variety of inflammatory and immunological disorders,” said Dr. Neal Walker, Chief Executive Officer of Aclaris. “Based on the strong safety and tolerability profile and dose proportional pharmacokinetic and pharmacodynamic profiles that support the potential for an extended dosing schedule of up to every three months and the potential for synergistic efficacy resulting from its dual inhibition of TSLP and IL-4Rα, we are rapidly progressing this molecule through two proof-of-concept studies and plan to initiate a Phase 2b program in the fourth quarter of 2026.” Continued Dr. Walker, “We also intend to initiate a phased multi-part Phase 2b basket study in lichen planus with ATI-2138 later this year. ATI-2138 is the only known drug that hits pathogenic T cells, the key drivers of in...

- Participants with Atopic Dermatitis Receiving ATI-2138 Experienced Improvements in Key Clinical Measures including Disease Severity, Itch, and Quality of Life - WAYNE, Pa., March 27, 2026 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel product candidates for immuno-inflammatory diseases, today provided additional results from its Phase 2a trial of ATI-2138, a potent and selective investigational oral covalent inhibitor of ITK and Janus kinase 3 (JAK3), presented in an electronic poster at the 2026 American Academy of Dermatology (AAD) Annual Meeting in Denver, CO. “We have continued to achieve important milestones for our potential best-in-class ITK inhibitor franchise, including the presentation of additional positive results from our open-label Phase 2a trial of ATI-2138 at this year’s AAD meeting,” said Dr. Jesse Hall, Chief Medical Officer of Aclaris. “Beyond the previously disclosed efficacy measures, patients receiving ATI-2138 experienced substantial improvements in disease severity, itch, affected percentage of body surface area, and disease-related quality of life measures. In total, these results further validate the strong mechanistic rationale for the use of ATI-2138 in a wide variety of immuno-inflammatory diseases.” 2026 American Academy of Dermatology (AAD) Annual Meeting In an ePoster (74636) entitled, “Results from an Open-Label Phase 2 Trial of ATI-2138, an Investigational Oral Covalent Inhibitor of Interleukin-2-Inducible T Cell Kinase (ITK) And Janus Kinase 3 (JAK3), in Patients with Moderate-To-Severe Atopic Dermatitis (AD),” the Company provided results showing that ATI-2138 was well tolerated and exposure to the compound led to rapid and sustained improvements in clinical signs and symptoms of AD. The ePoster can be accessed here. At end of treatment (week 12), patients receiving a low dose (10 mg BID) of ATI-2138 experienced a 77% improvement in extent and severity of atopic dermatitis (AD) as measured by the Eczema Area and Severity Index (EASI). Additional week 12 results presented at AAD included that patients receiving ATI-2138 experienced: A 70% improvement in the affected percentage of Body Surface Area (BSA) score. A 50% improvement in improvement in Peak Pruritus Numerical Rating Scale (PP-NRS), a validated scale for evaluating worst itch i...

WAYNE, Pa., March 20, 2026 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel product candidates for immuno-inflammatory diseases, today announced that an ePoster on the results from its open-label Phase 2a trial of ATI-2138, a potent and selective investigational oral covalent inhibitor of interleukin-2-inducible T cell kinase (ITK) and Janus kinase 3 (JAK3), will be available during the 2026 American Academy of Dermatology (AAD) Annual Meeting in Denver, CO. The poster will include results not previously reported from Aclaris’ Phase 2a trial in patients with moderate-to-severe atopic dermatitis (AD). Electronic Poster Details: About Aclaris Therapeutics, Inc. Aclaris Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing a pipeline of novel product candidates to address the needs of patients with immuno-inflammatory diseases who lack satisfactory treatment options. The company has a multi-stage portfolio of product candidates powered by a robust R&D engine. For additional information, please visit www.aclaristx.com and follow Aclaris on LinkedIn. Aclaris Therapeutics Contact: Will Roberts Senior Vice President Corporate Communications and Investor Relations (484) 329-2125 [email protected]

WAYNE, Pa., Feb. 26, 2026 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel product candidates for immuno-inflammatory diseases, today announced its financial results for the fourth quarter and full year ended 2025 and provided a corporate update. “2025 was a year of strong business execution and continued momentum in each of our potential best-in-class programs and positioned us for an exciting 2026 with important milestones and data readouts expected from each program,” stated Dr. Neal Walker, Chief Executive Officer and Chair of the Board of Directors of Aclaris. “2026 started with derisking events for two of our key programs, ITK and ATI-052; this included compelling ATI-052 interim Phase 1a SAD/MAD results showing strong safety and tolerability profiles, robust target engagement reinforcing the potency of the compound even at very low doses, and the opportunity for extended dosing supported by dose proportional pharmacokinetic and pharmacodynamic profiles. Since then, we have initiated two Phase 1b POC trials with ATI-052, with top line results expected from both trials in the second half of this year. With a strong cash position and several meaningful catalysts across our biologics and ITK pipeline expected this year, including top line results from the Phase 2 trial of our anti-TSLP monoclonal antibody bosakitug in AD, we are looking forward to an exciting and productive year.” Fourth Quarter 2025 Highlights and Recent Updates Pipeline: Biologics: Antibody Franchise Provided Positive Interim Results of Phase 1a Single (SAD) and Multiple Ascending Dose (MAD) Trial of Investigational Bispecific Anti-TSLP/IL-4Rα Antibody ATI-052; Complete Top Line Results from SAD and MAD Cohorts Expected in the Second Quarter of 2026: ATI-052 was well tolerated and demonstrated a favorable safety profile across all single and multiple ascending dose cohorts in this Phase 1a trial. Interim results included a dose proportional pharmacokinetic (PK) profile and concentration-dependent pharmacodynamics (PD) validating the potency and specificity of the compound, including robust target engagement and near complete target occupancy even at very low doses. These results support the potential for up to every three months dosing. Additional SAD and MAD results from this trial are expected in the...

WAYNE, Pa. (AP) — WAYNE, Pa. (AP) — Aclaris Therapeutics Inc. (ACRS) on Thursday reported a loss of $19.8 million in its fourth quarter. The Wayne, Pennsylvania-based company said it had a loss of 16 cents per share. The results missed Wall Street expectations. The average estimate of five analysts surveyed by Zacks Investment Research was for a loss of 15 cents per share. The specialty pharmaceutical company posted revenue of $1.3 million in the period, which also missed Street forecasts. Five analysts surveyed by Zacks expected $1.9 million. For the year, the company reported that its loss narrowed to $64.9 million, or 53 cents per share. Revenue was reported as $7.8 million. The company's shares closed at $3.31. A year ago, they were trading at $2.06. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on ACRS at https://www.zacks.com/ap/ACRS

On February 2, BML Capital Management disclosed in a Securities and Exchange Commission filing that it sold out of Alumis (NASDAQ:ALMS), liquidating 1,210,415 shares in an estimated $4.83 million trade. According to a Securities and Exchange Commission (SEC) filing dated February 2, BML Capital Management reported a complete sale of its 1,210,415-share stake in Alumis (NASDAQ:ALMS). As a result, the fund's quarter-end position value in Alumis decreased by $4.83 million, and it now holds no shares. Top holdings after the filing: NASDAQ: ACRS: $42.89 million (38.0% of AUM) NASDAQ: AVIR: $26.74 million (23.7% of AUM) NASDAQ: ORMP: $9.03 million (8.0% of AUM) NASDAQ: TIL: $7.10 million (6.3% of AUM) NASDAQ: PMVP: $6.62 million (5.9% of AUM) As of February 2, shares of Alumis were priced at $26.42, up a staggering 255.1% over the prior year and well outperforming the S&P 500’s roughly 15% gain in the same period. Alumis develops clinical-stage therapies for autoimmune and neuroinflammatory disorders, including ESK-001 and A-005 targeting TYK2 inhibition. The company operates a biopharmaceutical business model focused on advancing proprietary drug candidates through clinical trials toward regulatory approval and commercialization. It targets patients with autoimmune diseases such as plaque psoriasis, systemic lupus erythematosus, and neurodegenerative conditions. Alumis is a clinical-stage biotechnology company specializing in the development of novel therapies for autoimmune and neuroinflammatory diseases. The company leverages expertise in TYK2 inhibition to advance a pipeline of differentiated drug candidates addressing significant unmet medical needs. With a focus on innovation and clinical rigor, Alumis seeks to establish a competitive position in the biopharmaceutical sector through targeted therapeutic development. BML Capital’s move is a reminder that even disciplined portfolio decisions can collide with fast-moving catalysts. The sale was completed by December 31, as of the filing’s period-end date, before Alumis announced its January upsized public offering and before shares went on to surge roughly 200% in the weeks that followed. At the time, the decision was defensible. Alumis was a clinical-stage biotech with no approved products and heavy R&D spend. As of the third quarter, the company reported $377.7 million in cash and marketable securities, but a...

- Positive Interim Results of Phase 1a Single (SAD) and Multiple Ascending Dose (MAD) Trial Reinforce Potential Best-in-Class Potency Advantage of ATI-052 - - Trial Results Support Potential for Extended Dosing of up to Every Three Months - - Initiation of Phase 1b Proof-of-Concept (POC) Trials in Atopic Dermatitis (AD) and Asthma Now Expected in First Quarter of 2026; Planning Underway for Advancement of ATI-052 into Phase 2b Trial in AD in the Second Half of 2026 - - Management to Host a Conference Call to Discuss Update Today at 8:00 AM EST - WAYNE, Pa., Jan. 06, 2026 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel product candidates for immuno-inflammatory diseases, today announced positive interim results from the first-in-human Phase 1a single (SAD) and multiple ascending dose (MAD) trial of its anti-TSLP/IL-4Rα bispecific antibody ATI-052. “Aclaris has experienced significant momentum across our pipeline over the past few months; consistent with that strong momentum, we are pleased to report positive interim results from our Phase 1a SAD/MAD trial of ATI-052 that exceeded our expectations,” said Dr. Neal Walker, Chief Executive Officer of Aclaris. “ATI-052 demonstrated a strong safety and tolerability profile, dose proportional pharmacokinetic profile, and concentration-dependent pharmacodynamics even at the lowest dose – all of which support its best-in-class potential in a variety of inflammatory and immunological diseases due to its ability to uniquely impact multiple pathways of inflammation.” Dr. Walker continued, “These impressive results further validate ATI-052 and reinforce its potential best-in-class potency; given these results, we are rapidly advancing the clinical development of the compound. We expect to initiate Phase 1b proof-of-concept trials in AD and asthma shortly, and planning is already underway for initiation of a Phase 2b trial in AD in the second half of 2026.” Interim Phase 1a SAD/MAD Results The randomized, blinded, placebo-controlled Phase 1a portion of the first-in-human study was designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of subcutaneously administered ATI-052 in healthy adults receiving single ascending doses (SAD) and multiple ascending doses (MAD). In the SAD portion, four cohorts o...

WAYNE, Pa. (AP) — WAYNE, Pa. (AP) — Aclaris Therapeutics Inc. (ACRS) on Thursday reported a loss of $14.6 million in its third quarter. On a per-share basis, the Wayne, Pennsylvania-based company said it had a loss of 12 cents. The results beat Wall Street expectations. The average estimate of five analysts surveyed by Zacks Investment Research was for a loss of 13 cents per share. The specialty pharmaceutical company posted revenue of $3.3 million in the period, which also topped Street forecasts. Five analysts surveyed by Zacks expected $1.6 million. The company's shares closed at $2.26. A year ago, they were trading at $2.22. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on ACRS at https://www.zacks.com/ap/ACRS

- Positive Results from Phase 2a Trial of ITK/JAK3 Inhibitor ATI-2138 Presented at the 2025 European Academy of Dermatology and Venereology (EADV) Congress, Further Validating ITK as Therapeutic Target; Initiation of Phase 2 Trial in an Additional Indication Expected in the First Half of 2026 - - Timelines Reiterated for Top Line Clinical Results from Ongoing Trials of Investigational Anti-TSLP Monoclonal Antibody Bosakitug (ATI-045) and Anti-TSLP/IL-4R Bispecific Antibody ATI-052 - - Initiation of Phase 1b Proof-of-Concept Trials of ATI-052 in Asthma and Atopic Dermatitis (AD) Expected in the First Half of 2026 - - Strong Cash Runway Expected to Fund Operations into the Second Half of 2028 - WAYNE, Pa., Nov. 06, 2025 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel product candidates for immuno-inflammatory diseases, today announced its financial results for the third quarter of 2025 and provided a corporate update. “Aclaris is advancing a diversified pipeline of product candidates designed to overcome the limitations of existing therapies for certain immuno-inflammatory disorders, and the third quarter was a period of continued execution in that regard,” said Dr. Neal Walker, Chief Executive Officer and Chair of the Board of Directors of Aclaris. “The strong top line results from our Phase 2a trial of ATI-2138 in atopic dermatitis are emblematic of our execution during the quarter. As we described during our October R&D Day, our progress is tangible and significant. We have two immune franchise areas in oral kinase inhibitors and biologics which we expect to drive four clinical stage product candidates in 2026, addressing validated and therapeutically relevant immune targets. We have an expected cash runway that provides nearly three years of capital with opportunities to expand it further without dilution and look forward to a rich calendar of anticipated clinical milestones and data events throughout 2026 and 2027.” Third Quarter 2025 Highlights and Recent Updates Pipeline: Oral Inhibitors: ITK Franchise Announced Anticipated Phase 2 Trial of ATI-2138, a Potent and Selective Investigational Inhibitor of ITK and JAK3, in an Additional Indication: Aclaris expects to further assess ATI-2138 in additional unaddressed chronic, inflammatory, immune-mediated disorders, such as...