To apply Ivarmacitinib for the prevention of acute graft-versus-host disease (aGVHD) in HLA haploidentical transplantation, the incidence of grade II-IV aGVHD after prevention, the incidence of primary graft failure, the rate of GVHD-free relapse-free survival (GRFS) (12 months), the incidence of infection, the incidence of chronic graft-versus-host disease (cGvHD) (100 days - 1 year), treatment-related mortality, the incidence and severity of cytokine release syndrome (CRS), and the safety of the prevention regimen will be evaluated.

Start Date14 Feb 2026

Sponsor / Collaborator

Hematology Hospital of Chinese Academy of Medical Sciences

100 Clinical Results associated with Ivarmacitinib

100 Translational Medicine associated with Ivarmacitinib

100 Patents (Medical) associated with Ivarmacitinib

Literatures (Medical) associated with Ivarmacitinib

31 Dec 2026·JOURNAL OF DERMATOLOGICAL TREATMENT

Ivarmacitinib in patients with moderate to severe atopic dermatitis stratified by baseline characteristics: a post-hoc analysis of a phase 3 clinical trial

Article

Author: Xu, Jinhua ; Yin, Huibin ; Gu, Chaoying ; Tang, Suwei ; Chen, Aijun

BACKGROUND:

Ivarmacitinib (SHR0302) is a novel and highly selective Janus kinase 1 inhibitor for treating moderate to severe atopic dermatitis (AD).

OBJECTIVE:

This study aimed to evaluate the impacts of patient characteristics on the efficacy and safety of Ivarmacitinib.

METHODS:

This post-hoc analysis used data from a randomized, double-blind, placebo-controlled, multicenter phase 3 trial of Ivarmacitinib in patients with moderate to severe AD in which patients were randomized (1:1:1) to receive Ivarmacitinib 4 mg or 8 mg or placebo for 16 weeks. Subgroup analyses were conducted based on baseline characteristics.

RESULTS:

At week 16, both Ivarmacitinib 4 or 8 mg showed better efficacy over placebo in achieving Eczema Area and Severity Index (EASI) 75, EASI 90, and Worst Itch Numeric Rating Scale (WI-NRS) score ≥4-point responses in most subgroups based on age, sex, body mass index, AD duration, Investigator's Global Assessment score, EASI score, WI-NRS score, body surface area involvement, history of comorbid allergies, or previous systemic therapies. The overall incidence of adverse events and most of the adverse events of special interest were similar between Ivarmacitinib and placebo across all subgroups.

CONCLUSION:

Ivarmacitinib demonstrated efficacy and good tolerability in treating moderate to severe AD with diverse patient characteristics.

01 Jan 2026·INFLAMMOPHARMACOLOGY

Ivarmacitinib provides rapid and continuous improvement in patients with moderate-to-severe atopic dermatitis: a focus on different anatomical regions

Article

Author: Zhou, Bingjing ; Xiong, Feng ; Jia, Qiqi ; Li, Shuying ; Yu, Pian ; Shui, Xinyu ; Jiang, Meiyun ; Cao, Qiaozhi ; Li, Jie ; Huang, Siting ; Yi, Xiaoqing

OBJECTIVE:

Ivarmacitinib (SHR0302) has demonstrated promising efficacy and safety profiles in patients with moderate-to-severe atopic dermatitis (AD). This study aimed to investigate the effects of ivarmacitinib on the extent and severity of moderate-to-severe AD across anatomical regions.

METHODS:

A post-hoc analysis was performed based on the data from a phase III trial of ivarmacitinib (NCT04875169). Patients receiving ivarmacitinib or placebo were included in this study. Eczema Area and Severity Index (EASI) score was assessed in four regions, including the head/neck, upper extremities, trunk, and lower extremities. EASI 75/90/100 response was defined as ≥ 75.0%/90.0%/100.0% improvement in EASI score from baseline.

RESULTS:

There were 112, 113, and 111 patients in the ivarmacitinib 8 mg, ivarmacitinib 4 mg, and placebo groups, respectively. Reductions in EASI scores from baseline for four regions (head/neck, upper extremities, trunk, and lower extremities) were greater in the ivarmacitinib 8 mg and 4 mg groups than in the placebo group at week (W) 1 and sustained until W16. Higher response rates of EASI 100, 90, and 75 across four regions were also observed in ivarmacitinib 8 mg and 4 mg groups versus the placebo group at W4, W8, W12 and W16. Moreover, most of the reductions in EASI erythema, edema/papulation, excoriation, and lichenification scores from baseline to W16 across four regions were greater in the ivarmacitinib 8 mg and 4 mg groups than in the placebo group.

CONCLUSION:

Ivarmacitinib provides rapid and continuous improvement across all anatomical regions in patients with moderate-to-severe AD.

31 Dec 2025·JOURNAL OF DERMATOLOGICAL TREATMENT

Efficacy and safety of Ivarmacitinib in moderate-to-severe atopic dermatitis patients with or without previous systemic treatments: a post-hoc analysis of a phase III trial

Article

Author: Wang, Yuyi ; Long, Juan ; Huang, Yan ; Li, Min ; Li, Jiajia ; Jia, Ruiling ; Zhao, Peng ; Ning, Chunzhu ; Diao, Qingchun ; Lu, Fang ; Zhang, Qin

BACKGROUND:

Prior exposure to systemic treatments may affect treatment outcomes in moderate-to-severe atopic dermatitis (AD).

OBJECTIVE:

This study aimed to explore the efficacy and safety of Ivarmacitinib (SHR0302) in moderate-to-severe AD patients with or without previous systemic treatments.

METHODS:

This was a post-hoc analysis of a phase III clinical trial of Ivarmacitinib in moderate-to-severe AD (NCT04875169). Subgroup analysis by with (N = 132) or without (N = 204) previous systemic treatments (systemic corticosteroids, biologics, or other immunomodulators) was performed.

RESULTS:

In patients with previous systemic treatments, Ivarmacitinib 8 mg (n = 34) and 4 mg (n = 53) exhibited higher Investigator Global Assessment (IGA), Eczema Area and Severity Index (EASI)-75, EASI-90, and Worst Itch Numeric Rating Scale (WI-NRS) 4 response rates, and a greater reduction in Dermatology Life Quality Index (DLQI) score compared with placebo (n = 45) at most timepoints from W4 to W16. In patients without previous systemic treatments, these outcomes were notably increased in Ivarmacitinib 8 mg (n = 78) and 4 mg (n = 60) versus placebo (n = 66) throughout W4 to W16. The adverse events were generally comparable between Ivarmacitinib and placebo groups, regardless of previous systemic treatments.

CONCLUSION:

Ivarmacitinib demonstrates good efficacy and a favorable safety profile in moderate-to-severe AD patients, irrespective of previous systemic treatments.

News (Medical) associated with Ivarmacitinib

28 Oct 2025

·investors.arcutis.com

Arcutis Outlines Strategy for Driving Sustainable Growth and Announces Third Quarter 2025 Financial Results

Q3 2025 net product revenue for ZORYVE® (roflumilast) was $99.2 million, a 122% increase compared to Q3 of 2024, and a 22% increase compared to Q2 of 2025 ZORYVE cream 0.05% received U.S. Food and Drug Administration (FDA) approval for the treatment of atopic dermatitis in children down to 2 years of age in October Company provides initial 2026 full year net product sales guidance of $455–$470 million WESTLAKE VILLAGE, Calif., Oct. 28, 2025 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today outlined its strategy to achieve sustainable growth and reported financial results for the quarter ended September 30, 2025. Arcutis will review both topics at its Investor Day, which begins today at 10:30 a.m. Eastern Time (ET). “Over the past nine years, we have built Arcutis into an undisputed leader in medical dermatology. With ZORYVE, we have developed a portfolio of revolutionary topical treatments that are reshaping the treatment of chronic inflammatory skin diseases and demonstrating sustainable commercial momentum across all strengths and indications,” said Frank Watanabe, president and chief executive officer. “This success provides a tremendous foundation for sustained, long-term growth—offering the opportunity to reinvest in the ZORYVE franchise, systematically evaluate new opportunities, and expand our pipeline with new molecules that leverage our deep expertise in dermatology, as well as our best-in-class development and commercialization capabilities.” In today's Investor Day presentation, Arcutis management will discuss how the Company intends to: Grow the current ZORYVE franchise through continued conversion of the topical corticosteroid market, where 17 million prescriptions are written by dermatology clinicians every year for patients in ZORYVE-approved indications; Expand ZORYVE into new markets through potential additional indications, beginning with Phase 2 proof-of-concept trials evaluating ZORYVE foam 0.3% in vitiligo and hidradenitis suppurativa; Build the Company's clinical pipeline with the advancement of ARQ-234 and potentially through external innovation; Allocate capital responsibly to fuel this strategy, as well as improve the Company's long-term financial outlook; and Drive to potential peak ZORYVE sales of $2.6–$3.5 billion per annum across current and potential future indications, based on an assumed 15%-20% share of topical corticosteroid volume. Third Quarter 2025 Financial Results and Business Updates Commercial Highlights ZORYVE - a highly potent and selective phosphodiesterase-4 (PDE4) inhibitor in once-daily cream and foam formulations, approved in the United States for the treatment of plaque psoriasis, atopic dermatitis, and seborrheic dermatitis. ZORYVE net product sales for the third quarter of 2025 were $99.2 million, reflecting 22% sequential growth over the second quarter of 2025 and 122% year-over-year growth. Sequential growth was driven by increasing demand across products, the launch of ZORYVE foam 0.3% in plaque psoriasis of the scalp and body, and improved gross-to-net (GTN) pricing. Following FDA approval in early October, the Company will launch ZORYVE cream 0.05% for the treatment of atopic dermatitis in children ages 2 to 5 by the end of October. Clinical and Regulatory Developments The Company has begun enrolling patients in Phase 2 proof-of-concept studies with ZORYVE foam 0.3% for the treatment of patients with vitiligo, as well as patients with hidradenitis suppurativa, the first trials in the Company's effort to investigate further indication expansion opportunities for ZORYVE. The Company is preparing to initiate a Phase 1 study of ARQ-234, a fusion protein that is a potent and highly selective checkpoint agonist of the CD200 receptor being developed as a potential biologic treatment in atopic dermatitis. Corporate Updates ZORYVE cream and ZORYVE foam were awarded the "2025 Best of Beauty Breakthrough Award" by Allure, making it the first FDA-approved medication for atopic dermatitis, plaque psoriasis, and seborrheic dermatitis to win this prestigious award. Arcutis was named to Fortune Best Workplaces in BioPharma™ 2025 list for the fourth consecutive year. The Company obtained one new U.S. patent in Q3 2025 related to topical roflumilast foam compositions. Third Quarter 2025 Summary Financial Results Product revenues for the quarter ended September 30, 2025 were $99.2 million compared to $44.8 million for the corresponding period in 2024. Revenues for the quarter were $30.5 million for ZORYVE cream 0.3%, $18.9 million for ZORYVE cream 0.15%, and $49.8 million for ZORYVE topical foam 0.3%. The year-over-year increase was primarily due to increased unit demand. GTN rates remained favorable for ZORYVE, driven by a high percentage of prescriptions being reimbursed. Cost of sales for the quarter ended September 30, 2025 was $8.7 million compared to $5.5 million for the corresponding period in 2024, due to increasing ZORYVE sales. Research and development (R&D) expenses for the quarter ended September 30, 2025 were $19.6 million compared to $19.5 million for the corresponding period in 2024. Expenses remained consistent year over year, as increased development costs for roflumilast in pediatric atopic dermatitis were largely offset by a decrease in development costs for ARQ-255 and preclinical expenses. Selling, general, and administrative (SG&A) expenses for the quarter ended September 30, 2025 were $62.4 million compared to $58.8 million for the corresponding period in 2024. The year-over-year increase was primarily driven by increased sales and marketing and personnel-related expenses due to the Company's continued commercialization efforts for ZORYVE. Net income was $7.4 million, or $0.06 per basic and diluted earnings per share, for the quarter ended September 30, 2025 compared to a net loss of $41.5 million, or $0.33 per basic and diluted loss per share, for the corresponding period in 2024. Cash, cash equivalents, restricted cash, and marketable securities were $191.4 million as of September 30, 2025, compared to $228.6 million as of December 31, 2024. Net cash used in operating activities was $1.8 million during the third quarter. Financial Guidance Arcutis anticipates net product revenue of between $455 million and $470 million for the full year 2026. Conference Call and WebcastArcutis management will host a virtual Investor Day today at 10:30 a.m. ET to discuss its strategy for sustained long-term growth, as well as financial results for the third quarter. The webcast for this event can be accessed at the “Events” section of the Company’s website. The replay of the webcast will be available on the Arcutis website following the event. About Arcutis Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is a commercial-stage medical dermatology company that champions meaningful innovation to address the urgent needs of individuals living with immune-mediated dermatological diseases and conditions. With a commitment to solving the most persistent patient challenges in dermatology, Arcutis has a growing portfolio of advanced targeted topicals approved to treat three major inflammatory skin diseases. Arcutis’ unique dermatology development platform coupled with our dermatology expertise allows us to develop differentiated therapies against biologically validated targets, and has produced a robust pipeline for a range of inflammatory dermatological conditions. For more information, visit www.arcutis.com or follow Arcutis on LinkedIn, Facebook, Instagram and X Forward Looking StatementsThis press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. For example, statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on the Company's current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding the potential to address large markets with significant unmet need; the development, approval, and potential commercialization of product candidates and expanded indications; the potential commercial success and growth of ZORYVE in plaque psoriasis, seborrheic dermatitis, and atopic dermatitis, including peak sales, market access and reimbursement, product demand growth and developments regarding GTN; and the timing of regulatory filings and potential approvals. These statements involve substantial known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements and you should not place undue reliance on our forward-looking statements. Risks and uncertainties that may cause our actual results to differ include risks inherent in the clinical development process and regulatory approval process, the timing of regulatory filings, the timing, expenses, and success of our commercialization efforts, including uncertainty of future commercial sales and related items that can impact net sales, and our ability to defend our intellectual property. For a further description of the risks and uncertainties applicable to our business, see the “Risk Factors” section of our Form 10-K filed with U.S. Securities and Exchange Commission (SEC) on February 25, 2025, as well as any subsequent filings with the SEC. Any forward-looking statements that the company makes in this press release are made pursuant to the Private Securities Litigation Reform Act of 1995, as amended, and speak only as of the date of this press release. Except as required by law, we undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available. Contacts: MediaAmanda Sheldon, Head of Corporate Communicationsmedia@arcutis.com InvestorsBrian Schoelkopf, Head of Investor Relationsir@arcutis.com

Drug ApprovalPhase 2Financial StatementPhase 1

06 Aug 2025

·investors.arcutis.com

Arcutis Announces Second Quarter 2025 Financial Results and Provides Business Update

Q2 2025 net product revenue for ZORYVE® (roflumilast) was $81.5 million, a 164% increase compared to Q2 of 2024, and a 28% increase compared to Q1 of 2025, driven by strong portfolio demand growth ZORYVE foam 0.3% received U.S. Food and Drug Administration (FDA) approval for the treatment of plaque psoriasis of the scalp and body in adults and adolescents 12 years of age and older Initiated INTEGUMENT-INFANT study to evaluate the safety and efficacy of ZORYVE cream 0.05% in infants with atopic dermatitis ages 3 months to 24 months Submitted Investigational New Drug Application (IND) for ARQ-234, a novel fusion protein for the potential treatment of patients with atopic dermatitis WESTLAKE VILLAGE, Calif., Aug. 06, 2025 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today reported financial results for the quarter ended June 30, 2025, and provided a business update. “We continue to advance our strategy to become the leading medical dermatology company. This quarter, we generated strong net product revenues of $81.5 million from our ZORYVE portfolio, launched a new indication for ZORYVE foam for scalp and body psoriasis, and continued to advance our pipeline. Demand for ZORYVE continues to grow steadily, and we recently surpassed 1 million prescriptions dispensed, underscoring clinicians’ trust in ZORYVE as their preferred steroid-free topical treatment across our four approved indications, thanks to its consistent, robust efficacy and favorable safety and tolerability,” said Frank Watanabe, president and chief executive officer. “Looking ahead, we remain focused on expanding the approved uses of ZORYVE to the youngest patients, with the potential Q4 approval of ZORYVE cream 0.05% for 2 to 5 year olds with atopic dermatitis and the initiation of an infant atopic dermatitis study. Together with our efforts to evaluate potential further indications for ZORYVE and the continued advancement of ARQ-234, we are well positioned for long-term, sustainable growth.” Program Updates / Key Milestones ZORYVE cream - a highly potent and selective phosphodiesterase-4 (PDE4) inhibitor in a once-daily cream formulation, approved in the United States for the treatment of plaque psoriasis and atopic dermatitis. U.S. demand for ZORYVE cream 0.3% in plaque psoriasis continues to grow, with over 439,000 prescriptions filled since launch, reflecting the high levels of patient and physician satisfaction with the ZORYVE cream clinical profile. Launch of ZORYVE cream 0.15% in atopic dermatitis continues to gain momentum with over 99,000 prescriptions filled since launch. ZORYVE cream 0.15% received a strong recommendation from the American Association of Dermatology (AAD) in its recently updated guidelines for atopic dermatitis treatments for adults. The Company has been assigned a Prescription Drug User Fee Act (PDUFA) action date of October 13, 2025 for the supplemental New Drug Application (sNDA) for ZORYVE cream 0.05% for the treatment of atopic dermatitis in children ages 2 to 5 years old. In addition, the Company commenced a four-week Phase 2 study to evaluate investigational, once-daily ZORYVE cream 0.05% in infants as young as 3 months to less than 2 years with atopic dermatitis, which could potentially be the basis for further indication expansion. ZORYVE foam - a once-daily foam formulation of topical roflumilast designed to overcome the challenges of delivering topical drugs in hair-bearing areas of the body, approved in the United States for the treatment of seborrheic dermatitis and plaque psoriasis of the scalp and body. The Company received FDA approval for its sNDA for ZORYVE foam for scalp and body psoriasis in adult and adolescents 12 years of age and older in May 2025 and commenced sales in June 2025. Demand for ZORYVE foam 0.3% in seborrheic dermatitis and plaque psoriasis of the scalp and body continues to grow robustly each quarter, with over 405,000 prescriptions filled since launch, reflecting the high unmet need in these diseases. ARQ-234 - a fusion protein that is a potent and highly selective checkpoint agonist of the CD200 Receptor (CD200R), being developed as a potential biologic treatment in atopic dermatitis. The Company submitted its IND for ARQ-234 in July 2025. Other Pipeline Updates Following the evaluation of results from the Phase 1b trial of ARQ-255, a penetrating topical formulation of ivarmacitinib for the treatment of alopecia areata, the Company has elected to halt further development of this program. While clinical and biomarker results indicated some level of efficacy, the results did not meet the Company's threshold for advancement, and the Company has deprioritized the program given other R&D priorities across its portfolio. The Company has begun to investigate further indication expansion opportunities for ZORYVE, beginning with two recently initiated Phase 2 studies. Recent Corporate Highlights ZORYVE cream and ZORYVE foam received the Seal of Recognition from the National Psoriasis Foundation (NPF) in June 2025, the first time that the NPF has recognized a prescription product. ZORYVE cream 0.15% received a strong recommendation in the updated AAD guidelines for atopic dermatitis treatments for adults. The Company's successful pivotal Phase 3 ARRECTOR trial for ZORYVE foam 0.3% in scalp and body psoriasis was published in the Journal of the American Medical Association Dermatology in May 2025. Obtained three new U.S. patents in Q2 2025 related to topical roflumilast compositions. Second Quarter 2025 Summary Financial Results Product revenues for the quarter ended June 30, 2025 were $81.5 million compared to $30.9 million for the corresponding period in 2024. Revenues for the quarter were $27.7 million for ZORYVE cream 0.3%, $14.6 million for ZORYVE cream 0.15%, and $39.2 million for ZORYVE topical foam 0.3%. Year-over-year and quarter-over-quarter increases were due to increased unit demand. Gross-to-net (GTN) rates remain favorable for ZORYVE, driven by a high percentage of prescriptions being reimbursed. Cost of sales for the quarter ended June 30, 2025 were $7.5 million compared to $3.5 million for the corresponding period in 2024 due to increasing ZORYVE sales. Research and development (R&D) expenses for the quarter ended June 30, 2025 were $19.5 million compared to $19.3 million for the corresponding period in 2024. Expenses remained consistent year-over-year as decreased development costs for roflumilast in adult atopic dermatitis and plaque psoriasis were partially offset by an increase in development costs for pediatric atopic dermatitis and continued medical affairs investments to support medical education. Selling, general, and administrative (SG&A) expenses for the quarter ended June 30, 2025 were $69.2 million compared to $58.2 million for the corresponding period in 2024. The year-over-year increase was primarily driven by increased sales and marketing and personnel-related expenses due to our continued commercialization efforts for ZORYVE. Net loss was $15.9 million, or $0.13 per basic and diluted share, for the quarter ended June 30, 2025 compared to $52.3 million, or $0.42 per basic and diluted share, for the corresponding period in 2024. Cash, cash equivalents, restricted cash, and marketable securities were $191.1 million as of June 30, 2025, compared to $228.6 million as of December 31, 2024. Net cash provided by operating activities was $0.3 million during the second quarter as increased gross profit and timing changes in net working capital reduced cash used in operations. The company made the $10.0 million cash milestone payment to AstraZeneca for reaching a sales milestone of $250 million that was incurred in the first quarter of 2025, which is included as an investing activity. Conference Call and WebcastArcutis management will host a conference call and webcast today at 4:30 PM ET to discuss the financial results for the quarter and provide a business update. The webcast for this conference call may be accessed at the “Events” section of the Company’s website. The replay of the webcast will be available on the Arcutis website following the call. About Arcutis Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is a commercial-stage medical dermatology company that champions meaningful innovation to address the urgent needs of individuals living with immune-mediated dermatological diseases and conditions. With a commitment to solving the most persistent patient challenges in dermatology, Arcutis has a growing portfolio of advanced targeted topicals approved to treat three major inflammatory skin diseases. Arcutis’ unique dermatology development platform coupled with our dermatology expertise allows us to invent differentiated therapies against biologically validated targets, and has produced a robust pipeline for inflammatory dermatological conditions. For more information, visit www.arcutis.com or follow Arcutis on LinkedIn, Facebook, Instagram and X. Forward Looking StatementsThis press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. For example, statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on the Company's current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding the potential to address large markets with significant unmet need; the development, approval, and potential commercialization of product candidates; the potential commercial success and growth of ZORYVE in plaque psoriasis, seborrheic dermatitis, and atopic dermatitis, including market access and reimbursement, product demand growth and developments regarding GTN; and the timing of regulatory filings and potential approvals. These statements involve substantial known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements and you should not place undue reliance on our forward-looking statements. Risks and uncertainties that may cause our actual results to differ include risks inherent in the clinical development process and regulatory approval process, the timing of regulatory filings, the timing, expenses, and success of our commercialization efforts, including uncertainty of future commercial sales and related items that can impact net sales, and our ability to defend our intellectual property. For a further description of the risks and uncertainties applicable to our business, see the “Risk Factors” section of our Form 10-K filed with U.S. Securities and Exchange Commission (SEC) on February 25, 2025, as well as any subsequent filings with the SEC. Any forward-looking statements that the company makes in this press release are made pursuant to the Private Securities Litigation Reform Act of 1995, as amended, and speak only as of the date of this press release. Except as required by law, we undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available. Contacts:MediaAmanda Sheldon, Head of Corporate Communicationsmedia@arcutis.com InvestorsBrian Schoelkopf, Head of Investor Relationsir@arcutis.com

Clinical ResultDrug ApprovalPhase 3Phase 2Phase 1

06 May 2025

·investors.arcutis.com

Arcutis Announces First Quarter 2025 Financial Results and Provides Business Update

Q1 2025 net product revenue for ZORYVE® (roflumilast) was $63.8 million, a 196% increase compared to Q1 of 2024, and a 2% decrease compared to Q4 of 2024, due to typical first-quarter deductible resets and insurance changes, and excluding the non-recurring reduction in reserves for product return of $4.1 million reported in Q4 2024 Continued demand growth for ZORYVE of 10%, solidifying its position as most prescribed branded non-steroidal topical treatment across three major inflammatory skin conditions All three largest national Pharmacy Benefit Managers (PBMs) covering entire ZORYVE portfolio and Medicaid coverage continues to expand On April 3, 2025, the patent litigation against Padagis was stayed and the court cancelled all case deadlines, including the trial May 22, 2025 Prescription Drug User Fee Act (PDUFA) action date for ZORYVE foam 0.3% for treatment of individuals with plaque psoriasis of the scalp and body, 12 years and older WESTLAKE VILLAGE, Calif., May 06, 2025 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today reported financial results for the quarter ended March 31, 2025, and provided a business update. “In the first quarter we again delivered excellent performance driven by strong demand growth for our ZORYVE portfolio, which offers a distinct and compelling value proposition and provides healthcare providers and their patients with an effective and safe alternative to steroids. We have broad commercial coverage, are continuing to expand Medicaid coverage — with more than 1 in 2 recipients having coverage — and are maintaining our gross-to-net in the 50s,” said Frank Watanabe, president and chief executive officer. “With our team's execution of our strategy, strong financial position, multiple upcoming catalysts and market expansion opportunities, including additional indications and further coverage expansion for ZORYVE, as well as a promising pipeline, we are confident in our continued growth in 2025 and beyond.” Program Updates / Key Milestones ZORYVE cream - a highly potent and selective phosphodiesterase-4 (PDE4) inhibitor in a once-daily cream formulation, approved in the United States for the treatment of plaque psoriasis and atopic dermatitis. U.S. demand for ZORYVE cream 0.3% in plaque psoriasis continues to grow, with over 425,000 prescriptions filled since launch by over 18,000 unique prescribers, reflecting the high levels of patient and physician satisfaction with the ZORYVE cream clinical profile. ZORYVE cream 0.3% has reached its steady state gross-to-net (GTN). Launch of ZORYVE cream 0.15% in atopic dermatitis continues to gain momentum with over 69,000 prescriptions filled since launch, with coverage by the three largest national PBMs. The Company anticipates continued improvement in GTN for ZORYVE cream 0.15% in 2025, converging on the GTN of our other products. The Company submitted a supplemental New Drug Application (sNDA) for ZORYVE cream 0.05% to the FDA for the treatment of atopic dermatitis in children ages 2 to 5, and has been assigned a PDUFA action date of October 13, 2025. ZORYVE foam - a once-daily foam formulation of topical roflumilast designed to overcome the challenges of delivering topical drugs in hair-bearing areas of the body, approved in the United States for the treatment of seborrheic dermatitis, and under FDA review for scalp and body psoriasis. Demand for ZORYVE foam 0.3% in seborrheic dermatitis continues to grow robustly each quarter, with over 343,000 prescriptions filled since launch, reflecting the high unmet need in this disease. ZORYVE foam has gained commercial and Medicaid coverage in line with ZORYVE cream 0.3% and is nearing its steady state GTN. The Company submitted an sNDA for ZORYVE foam for scalp and body psoriasis to the FDA based on the positive results from the pivotal ARRECTOR Phase 3 trial and a Phase 2b trial, and has been assigned a PDUFA action date of May 22, 2025. ARQ-255 - a topical suspension formulation of ivarmacitinib, a potent and highly selective topical Janus kinase type 1 (JAK1) inhibitor, designed to preferentially deliver the drug deep into the hair follicle, in order to potentially treat alopecia areata at the site of inflammation. In September 2024, the Company announced that it completed enrollment in a Phase 1b study evaluating ARQ-255 for the treatment of alopecia areata, with data expected in the middle of 2025. ARQ-234 - a fusion protein that is a potent and highly selective checkpoint agonist of the CD200 Receptor (CD200R), being developed as a potential biologic treatment in atopic dermatitis. The Company has continued preclinical development efforts and is working towards submitting an Investigational New Drug application in 2025. Recent Corporate Highlights The Company appointed Latha Vairavan as Chief Financial Officer effective May 6, 2025. Obtained two new U.S. patents in Q1 2025 related to topical roflumilast compositions. In March 2025, at the request of Padagis, Arcutis agreed to a joint stipulation to stay the ongoing patent litigation with Padagis Israel Pharmaceuticals Ltd., Padagis US LLC, and Padagis LLC (Padagis). On April 3, 2025, the court stayed the case and cancelled all case deadlines, including the trial. The 30-month stay will be extended for each day the stay is in place starting March 24, 2025, until the stay is lifted. The parties are not in settlement discussions. In March 2025, Health Canada approved ZORYVE® (roflumilast) cream 0.15% for the treatment of atopic dermatitis in individuals 6 years of age and older, and the Company commenced sales in April. The positive results from Arcutis's pivotal Phase 3 trial of the efficacy and safety of ZORYVE cream 0.05% for the treatment of mild to moderate atopic dermatitis in children 2 to 5 years old was published in Pediatric Dermatology. First Quarter 2025 Summary Financial Results Product revenues for the quarter ended March 31, 2025 were $63.8 million compared to $21.6 million for the corresponding period in 2024. Revenues for the quarter were $23.4 million for ZORYVE (roflumilast) cream 0.3%, $30.2 million for ZORYVE (roflumilast) topical foam 0.3%, and $10.2 million for ZORYVE (roflumilast) cream 0.15%. Year-over-year increases were due to strong unit demand as well as improvements in GTN sales deductions. In addition, the first quarters of 2025 and 2024 included Other revenues of $2.0 million and $3.0 million, respectively, related to license revenues received in connection with the Huadong Pharmaceutical collaboration and licensing agreement. Q1 2024 also included Other revenues of $25.0 million from an upfront payment in connection with the Sato License Agreement. Cost of sales for the quarter ended March 31, 2025 were $8.8 million compared to $3.3 million for the corresponding period in 2024. The year-over-year increase was due to the cumulative catch-up adjustment related to the $10.0 million milestone payment to AstraZeneca achieved during the quarter, coupled with higher product revenues. Research and development (R&D) expenses for the quarter ended March 31, 2025 were $17.5 million compared to $23.1 million for the corresponding period in 2024. The year-over-year decrease was due to decreased clinical development costs related to our topical roflumilast program. Selling, general, and administrative (SG&A) expenses for the quarter ended March 31, 2025 were $64.0 million compared to $54.8 million for the corresponding period in 2024. The year-over-year increase was primarily due to compensation and personnel-related expenses for our continued commercialization efforts for ZORYVE. Net loss was $25.1 million, or $0.20 per basic and diluted share, for the quarter ended March 31, 2025 compared to $35.4 million, or $0.32 per basic and diluted share, for the corresponding period in 2024. Cash, cash equivalents, restricted cash, and marketable securities were $198.7 million as of March 31, 2025, compared to $228.6 million as of December 31, 2024. Net cash used in operating activities was $30.4 million during the first quarter. Conference Call and WebcastArcutis management will host a conference call and webcast today at 4:30 PM ET to discuss the financial results for the quarter and provide a business update. The webcast for this conference call may be accessed at the “Events” section of the Company’s website. The replay of the webcast will be available on the Arcutis website following the call. About Arcutis Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is a commercial-stage medical dermatology company that champions meaningful innovation to address the urgent needs of individuals living with immune-mediated dermatological diseases and conditions. With a commitment to solving the most persistent patient challenges in dermatology, Arcutis has a growing portfolio of advanced targeted topicals approved to treat three major inflammatory skin diseases. Arcutis’ unique dermatology development platform coupled with our dermatology expertise allows us to invent differentiated therapies against biologically validated targets, and has produced a robust pipeline with multiple follow-on clinical programs for a range of inflammatory dermatological conditions including atopic dermatitis and alopecia areata. For more information, visit www.arcutis.com or follow Arcutis on LinkedIn, Facebook, Instagram, and X. Forward Looking StatementsThis press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. For example, statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on the Company's current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding the potential to address large markets with significant unmet need; the development, approval and potential commercialization of product candidates; the potential commercial success and growth of ZORYVE in plaque psoriasis, seborrheic dermatitis, and atopic dermatitis, including market access and reimbursement, product demand growth and developments regarding GTN; and the timing of regulatory filings and potential approvals. These statements involve substantial known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements and you should not place undue reliance on our forward-looking statements. Risks and uncertainties that may cause our actual results to differ include risks inherent in the clinical development process and regulatory approval process, the timing of regulatory filings, the timing, expenses, and success of our commercialization efforts, including uncertainty of future commercial sales and related items that can impact net sales, and our ability to defend our intellectual property. For a further description of the risks and uncertainties applicable to our business, see the “Risk Factors” section of our Form 10-K filed with U.S. Securities and Exchange Commission (SEC) on February 25, 2025, as well as any subsequent filings with the SEC. Any forward-looking statements that the company makes in this press release are made pursuant to the Private Securities Litigation Reform Act of 1995, as amended, and speak only as of the date of this press release. Except as required by law, we undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available. Contacts:Media Amanda Sheldon, Head of Corporate Communications media@arcutis.com Investors Latha Vairavan, Chief Financial Officer ir@arcutis.com

Phase 3Phase 1Drug ApprovalFinancial StatementPhase 2

100 Deals associated with Ivarmacitinib

R&D Status

Approved

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Indication	Country/Location	Organization	Date
Alopecia Areata	China	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	24 Jun 2025
Moderate Atopic Dermatitis	China	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	01 Apr 2025
Severe Atopic Dermatitis	China	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	01 Apr 2025
Rheumatoid Arthritis	China	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	25 Mar 2025
Ankylosing Spondylitis	China	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	18 Mar 2025

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Axial Spondyloarthritis	NDA/BLA	China	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	22 Nov 2025
Mild Atopic Dermatitis	NDA/BLA	China	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	15 Feb 2025
Dermatitis, Atopic	NDA/BLA	China	Reistone Biopharma Co. Ltd.	09 Jun 2023
Non-radiographic axial spondyloarthritis	Phase 3	China	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	16 Aug 2022
Colitis, Ulcerative	Phase 3	Poland	Reistone Biopharma Co. Ltd.	11 Sep 2021
Arthritis, Psoriatic	Phase 3	China	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	30 Aug 2021
Nonsegmental vitiligo	Phase 3	China	Reistone Biopharma Co. Ltd.	29 Jan 2020
PD-L1-positive head and neck squamous cell carcinoma	Phase 2	China	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	31 Jul 2025
Recurrent Squamous Cell Carcinoma of the Head and Neck	Phase 2	China	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	31 Jul 2025
Chronic eczema	Phase 2	United States	Arcutis Biotherapeutics, Inc.	20 Apr 2020

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04481139 (Pubmed \| Front Pharmacol)	Phase 2/3	Ankylosing Spondylitis	373	Ivarmacitinib 4 mg	mhmuiyqbbq(gjcgnrgryu) = oyzffypsce tfgwdxezif (uzcsebbfji ) View more	Positive	20 Nov 2025
				Placebo	mhmuiyqbbq(gjcgnrgryu) = celhmhvxvv tfgwdxezif (uzcsebbfji ) View more
NCT04875169 (Pubmed \| JAMA Dermatol) Manual	Phase 3	Dermatitis, Atopic	336	Ivarmacitinib 4mg	kntgsqpknh(vrsmacwanx) = rfyhhfllqh vqtlugbyxc (csadekriid, 44.4 - 63.4) View more	Positive	01 Jul 2025
				Ivarmacitinib 8mg	kntgsqpknh(vrsmacwanx) = fuamcfooef vqtlugbyxc (csadekriid, 56.5 - 74.8) View more
NCT04333771 (EULAR2025)	Phase 3	-	566	Ivarmacitinib 4 mg	-	Positive	11 Jun 2025
				Ivarmacitinib 8 mg
NCT04333771 (EULAR2025)	Phase 3	Rheumatoid Arthritis	421	Ivarmacitinib 4 mg	-	Positive	11 Jun 2025
				Ivarmacitinib 8 mg
NCT05470413 (NEWS) Manual	Phase 3	Alopecia Areata	330	艾玛昔替尼 4 mg QD	guvksxuyin(xqsfwbhmmd) = fjplzfbvpc lvmoytlmaa (ihooqaogma ) View more	Positive	11 Mar 2025
				艾玛昔替尼 8 mg QD	guvksxuyin(xqsfwbhmmd) = swixiuixdw lvmoytlmaa (ihooqaogma ) View more
NCT04875169 (AAD2025)	Phase 3	Dermatitis, Atopic	346	Ivarmacitinib 4 mg	mlubqhbvjl(uvkdjtyfpj) = EASI scores for erythema, edema/papulation, excoriation, and lichenification in the four anatomical regions were significantly lower in both the ivarmacitinib 4 mg and 8 mg groups than in the placebo group at W16 (all P<0.05). gffaamumnk (odirwpkepc )	Positive	07 Mar 2025
				Ivarmacitinib 8 mg
NCT04875169 (AAD2025)	Phase 3	Dermatitis, Atopic	225	Ivarmacitinib (Early responders)	jqgaxzxduc(iogwdjxuul) = dunpyuadcm bcwiuedpki (vtkraodzoy ) View more	Positive	07 Mar 2025
				Ivarmacitinib (Non-early responders)	jqgaxzxduc(iogwdjxuul) = zxiqbbztlg bcwiuedpki (vtkraodzoy ) View more
NCT04875169 (AAD2025)	Phase 3	Dermatitis, Atopic	335	Ivarmacitinib 4 mg	-	Positive	07 Mar 2025
				Ivarmacitinib 8 mg
NCT04811131 (CTgov)	Phase 2	Nonsegmental vitiligo	114	NB-UVB phototherapy active treatment+ARQ-252 cream 0.3% (Active IP and Active Phototherapy)	iuphkqmvgz(yfwkjlkmwx) = aydxnutbam crevoltmww (hbehsgqjki, 25.0121) View more	-	12 Jul 2024
				NB-UVB phototherapy sham treatment+ARQ-252 cream 0.3% (Active IP and Sham Phototherapy)	iuphkqmvgz(yfwkjlkmwx) = bkneecvhsj crevoltmww (hbehsgqjki, 11.8841) View more
NEWS Manual	Phase 2/3	Ankylosing Spondylitis	373	SHR0302 4mg	qlxnebigeh(lqajpqtwhv) = uriltrsson hzozaqxgfj (dqjeylmfzd ) View more	Positive	15 Jun 2024
				Placebo	qlxnebigeh(lqajpqtwhv) = vmgjzsbulk hzozaqxgfj (dqjeylmfzd ) View more

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