ARQT Arcutis Biotherapeutics Inc.

28.21
-0.51  -2%
Previous Close 28.72
Open 28.94
52 Week Low 17.1
52 Week High 40.88
Market Cap $1,230,928,681
Shares 43,634,480
Float 23,451,432
Enterprise Value $1,067,177,265
Volume 82,105
Av. Daily Volume 195,574
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Upcoming Catalysts

Drug Stage Catalyst Date
ARQ-151
Plaque psoriasis
Phase 3
Phase 3
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ARQ-252
Chronic Hand Eczema
Phase 2b
Phase 2b
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ARQ-151
Atopic dermatitis
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
ARQ-154
Seborrheic dermatitis
Phase 3
Phase 3
Phase 3 trial to be initiated 2Q / 3Q 2021.
ARQ-151
Plaque psoriasis
Phase 2
Phase 2
Phase 2 long-term safety data noted 3.6% of patients experienced a treatment-related adverse event during 52 weeks of treatment - December 1, 2020.
ARQ-154
Scalp psoriasis
Phase 2b
Phase 2b
Phase 2b data released November 23, 2020. Primary endpoint met.
ARQ-252
Vitiligo
Phase 2a
Phase 2a
Phase 2 trial to be initiated in late-2020 or early-2021.

Latest News

    • Phase 3 development to consist of single pivotal trial
    • Previously reported data demonstrated that roflumilast foam provided statistically significant improvement and a favorable safety and tolerability profile
    • Roflumilast foam potential "Best in Class" topical PDE4 inhibitor
    • Seborrheic dermatitis affects 10 million U.S. patients

    WESTLAKE VILLAGE, Calif., Jan. 20, 2021 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT), a late-stage biopharmaceutical company focused on developing and commercializing treatments for unmet needs in immune-mediated dermatological diseases and conditions, or immuno-dermatology, today announced that it will advance its program to develop topical roflumilast foam (ARQ-154) as a treatment for seborrheic dermatitis

    • Phase 3 development to consist of single pivotal trial
    • Previously reported data demonstrated that roflumilast foam provided statistically significant improvement and a favorable safety and tolerability profile
    • Roflumilast foam potential "Best in Class" topical PDE4 inhibitor
    • Seborrheic dermatitis affects 10 million U.S. patients

    WESTLAKE VILLAGE, Calif., Jan. 20, 2021 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT), a late-stage biopharmaceutical company focused on developing and commercializing treatments for unmet needs in immune-mediated dermatological diseases and conditions, or immuno-dermatology, today announced that it will advance its program to develop topical roflumilast foam (ARQ-154) as a treatment for seborrheic dermatitis into Phase 3 following an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA). The Phase 3 program will consist of a single pivotal trial, which the Company anticipates initiating in the second or third quarter of 2021. Roflumilast foam is a once-daily topical foam formulation of roflumilast, a highly potent and selective phosphodiesterase type 4 (PDE4) inhibitor.

    "Following our interactions with the FDA, we are delighted to advance topical roflumilast foam into Phase 3 development for the treatment of seborrheic dermatitis, a disease that affects more than 10 million people in the U.S.," said Patrick Burnett, M.D., Ph.D., FAAD, Arcutis' Chief Medical Officer. "Results from our Phase 2 clinical trials with once-a-day topical roflumilast foam demonstrated that it provides statistically significant improvements in signs and symptoms of both seborrheic dermatitis and scalp psoriasis compared to a matching vehicle foam, while also being well tolerated. Unlike creams and ointments, roflumilast foam is suitable for use in hair-bearing areas; unlike steroids, it is expected to be suitable for long-term use, including on the face; and unlike shampoos, it is an elegant, quick drying, leave-in foam that doesn't need to be rinsed out. If successful in the Phase 3 clinical trial and approved for commercialization, roflumilast foam has the potential to become the standard of care in seborrheic dermatitis."

    "Patients are desperate to find new treatment options for seborrheic dermatitis, a common, chronic skin disease affecting the face and scalp that can profoundly affect patients' appearance and quality of life," said Matthew Zirwas, M.D., Founder of Bexley Dermatology Research Clinic and an investigator in the trial. "Dermatologists and patients face a real challenge, with current treatment options that are either safe or effective, but rarely both. Based on clinical results to date, topical roflumilast has shown to be safe and effective, rapidly improving both the appearance and the itch, dramatically improving patients' quality of life. Notably, it comes in a cosmetically-elegant foam that can be used chronically in multiple locations without the burning and stinging associated with other treatment options. If approved, topical roflumilast will be a revolutionary advancement in the treatment of seborrheic dermatitis."

    Roflumilast foam is a once-daily topical foam formulation of a highly potent and selective PDE4 inhibitor that Arcutis is developing particularly to treat inflammatory dermatoses in hair-bearing areas of the body such as the scalp, although it is usable in all areas of the body.

    Roflumilast has been approved by the FDA for systemic treatment to reduce the risk of exacerbations of chronic obstructive pulmonary disease (COPD) since 2011. Roflumilast has shown greater potency (25- to-300 fold) than the two other FDA-approved PDE4 inhibitors. PDE4 is an intracellular enzyme that increases the production of pro-inflammatory mediators and decreases production of anti-inflammatory mediators and has been implicated in a wide range of inflammatory diseases including psoriasis, eczema, and COPD. PDE4 is an established target in dermatology, and other PDE4 inhibitors have been approved by the FDA for the topical treatment of atopic dermatitis or the systemic treatment of plaque psoriasis.

    Arcutis believes roflumilast foam has significant potential as a treatment for seborrheic dermatitis. In a recently completed Phase 2 study of roflumilast foam in seborrheic dermatitis, roflumilast foam demonstrated statistically significant improvement over the vehicle foam on the trial's primary endpoint, Investigator Global Assessment (IGA) success, and multiple secondary endpoints including the reduction of itch. Once-daily roflumilast foam also demonstrated a favorable safety and tolerability profile. Additionally, other than a very small change in the formulation, roflumilast foam is identical to roflumilast cream (ARQ-151), Arcutis' investigational topical cream PDE4 inhibitor, which has demonstrated symptomatic improvement and a favorable tolerability profile in clinical trials in plaque psoriasis, including chronic treatment of psoriasis, as well as encouraging results in atopic dermatitis.

    Arcutis is currently conducting a Phase 2 long-term safety study in seborrheic dermatitis. This is a multicenter, open-label study of roflumilast foam 0.3% applied once daily in adolescent and adult patients with seborrheic dermatitis and includes patients who were treated previously in the Phase 2 trial, as well as patients naïve to treatment with topical roflumilast foam. Periodic clinic visits include assessments for clinical safety, application site reactions, and disease improvement, or progression.

    About Seborrheic Dermatitis

    Seborrheic dermatitis affects more than 10 million people in the U.S., and is a common, chronic or recurrent inflammatory skin disease that causes red patches covered with large, greasy, flaking yellow-gray scales, and persistent itch. Seborrheic dermatitis occurs most often on the scalp, face (especially on the nose, eyebrows, ears, and eyelids), upper chest, and back.

    About Arcutis - Bioscience, applied to the skin.

    Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT) is a late-stage biopharmaceutical company focused on developing and commercializing treatments for unmet needs in immune-mediated dermatological diseases and conditions, or immuno-dermatology. The company is leveraging recent advances in immunology and inflammation to develop differentiated therapies against biologically validated targets to solve persistent treatment challenges in serious diseases of the skin. Arcutis' robust pipeline includes four novel drug candidates currently in development for a range of inflammatory dermatological conditions. The company's lead product candidate, topical roflumilast, has the potential to revitalize the standard of care for plaque psoriasis, atopic dermatitis, scalp psoriasis, and seborrheic dermatitis. For more information, visit www.arcutis.com or follow the company on LinkedIn and Twitter.

    Forward Looking Statements

    This press release contains "forward-looking" statements, including, among others, statements regarding the potential of roflumilast foam to address the unmet needs in the topical treatment of seborrheic dermatitis; the potential safety and efficacy of roflumilast foam; and the initiation of a pivotal Phase 3 clinical trial in 2021. 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, 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-Q filed with U.S. Securities and Exchange Commission (SEC) on November 5, 2020, as well as any subsequent filings with the SEC. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available.

    Investors and Media:

    Heather Rowe Armstrong

    Vice President, Investor Relations & Corporate Communications



    805-418-5006, Ext. 740



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    • Roflumilast cream potential "Best in Class" topical PDE4 inhibitor
    • Atopic dermatitis affects approximately 19 million patients in the U.S.
    • The Company anticipates topline data in the second half of 2022

    WESTLAKE VILLAGE, Calif., Jan. 13, 2021 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT), a medical dermatology company developing innovative treatments for patients with immune-mediated dermatological diseases and conditions, today announced that it has commenced pivotal Phase 3 clinical trials evaluating topical roflumilast cream (ARQ-151) as a potential treatment for atopic dermatitis (AD). Roflumilast cream is a once daily topical formulation of roflumilast, a highly potent and selective phosphodiesterase type 4 inhibitor (PDE4…

    • Roflumilast cream potential "Best in Class" topical PDE4 inhibitor

    • Atopic dermatitis affects approximately 19 million patients in the U.S.
    • The Company anticipates topline data in the second half of 2022

    WESTLAKE VILLAGE, Calif., Jan. 13, 2021 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT), a medical dermatology company developing innovative treatments for patients with immune-mediated dermatological diseases and conditions, today announced that it has commenced pivotal Phase 3 clinical trials evaluating topical roflumilast cream (ARQ-151) as a potential treatment for atopic dermatitis (AD). Roflumilast cream is a once daily topical formulation of roflumilast, a highly potent and selective phosphodiesterase type 4 inhibitor (PDE4), which the Company is developing for plaque psoriasis and AD.

    "More than 19 million people in the U.S. suffer from atopic dermatitis, of which at least 60 percent are young children, thereby making safety and tolerability particularly important in this disease," said Patrick Burnett, M.D., Ph.D., FAAD, Arcutis' Chief Medical Officer. "Atopic dermatitis is characterized by a defect in the skin barrier, which results in a red, itchy rash that in many cases can cover significant areas of the body. Current treatments often fall short, resulting in patients, parents and physicians having to make trade-offs between efficacy, safety and tolerability."

    Dr. Burnett continued, "We are excited to begin our pivotal Phase 3 trials in patients with atopic dermatitis. If approved, roflumilast cream would be the first once-a-day topical nonsteroidal treatment for AD, and would also offer patients a cosmetically-elegant, non-greasy formulation. In clinical trials, roflumilast cream has demonstrated a benign safety and tolerability profile, without the local tolerability or safety issues associated with many other topical AD treatments, and importantly, unlike steroids, it can safely be used chronically. We believe topical roflumilast has the potential to eliminate the need to compromise between safety, efficacy, and tolerability, and we look forward to reporting topline data in the second half of 2022."

    The "INterventional Trial EvaluatinG roflUMilast cream for the treatmENt of aTopic dermatitis" 1 and 2 (or INTEGUMENT-1 and -2) are identical Phase 3, parallel group, double blind, vehicle-controlled trials in which roflumilast cream 0.15% or vehicle is applied once daily for 4 weeks to subjects 6 years of age and older with mild to moderate AD involving ≥3% body surface area.

    In each trial, approximately 650 subjects are planned to be randomized 2:1 to either roflumilast cream 0.15% or matching vehicle cream. The primary endpoint of both trials is Investigator Global Assessment (IGA) Success, defined as a Validated Investigator Global Assessment - Atopic Dermatitis (vIGA-AD) score of ‘clear' or ‘almost clear' plus a 2-grade improvement from baseline at Week 4. Multiple secondary endpoints will also be evaluated, including itch as measured by the Worst Itch-Numerical Rating Scale (WI-NRS) as well as the proportion of subjects who attain at least a 75% reduction in the Eczema Area and Severity Index (EASI-75) at Week 4. After completing INTEGUMENT-1 or -2, subjects may be eligible to enroll in a 12‑month, open label extension study (INTEGUMENT-OLE) evaluating once daily roflumilast cream. The Company anticipates topline data from INTEGUMENT-1 and -2 in the second half of 2022.

    Arcutis also plans to initiate a third pivotal Phase 3 study, the "INterventional Trial EvaluatinG roflUMilast cream for the treatmENt of aTopic dermatitis in PEDiatric patients" (or INTEGUMENT-PED) shortly to evaluate roflumilast cream in subjects 2 to 5 years of age with mild to moderate AD.

    About Atopic Dermatitis

    Atopic dermatitis (AD) is the most common type of eczema, occurring in approximately 6% of the U.S. population. AD is characterized by a defect in the skin barrier, which allows allergens and other irritants to enter the skin, leading to an immune reaction and inflammation. This reaction produces a red, itchy rash, most frequently occurring on the face, arms and legs, and the rash can cover significant areas of the body, in some cases half of the body or more. Disease onset is most common by 5 years of age, and the Company estimates that approximately 60% of patients suffering from AD are pediatric patients. The rash causes significant pruritus (itching), which can lead to skin damage caused by scratching or rubbing. Given that most of the patients are pediatric, the safety and tolerability of AD therapies is paramount.

    About Topical Roflumilast Cream

    Roflumilast Cream is a topical cream formulation of a highly potent and selective PDE4 inhibitor (roflumilast). Roflumilast has been approved by the U.S. Food and Drug Administration (FDA) for oral treatment to reduce the risk of exacerbations of chronic obstructive pulmonary disease (COPD) since 2011. Roflumilast has shown greater potency (25- to 300-fold) than the two other FDA-approved PDE4 inhibitors. PDE4 is an intracellular enzyme that increases the production of pro-inflammatory mediators and decreases production of anti-inflammatory mediators and has been implicated in a wide range of inflammatory diseases including psoriasis, eczema, and COPD. PDE4 is an established target in dermatology, and other PDE4 inhibitors have been approved by the FDA for the topical treatment of atopic dermatitis or the systemic treatment of plaque psoriasis.

    About Arcutis - Bioscience, applied to the skin.

    Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT) is a late-stage biopharmaceutical company focused on developing and commercializing treatments for unmet needs in immune-mediated dermatological diseases and conditions, or immuno-dermatology. The company is leveraging recent advances in immunology and inflammation to develop differentiated therapies against biologically validated targets to solve persistent treatment challenges in serious diseases of the skin. Arcutis' robust pipeline includes four novel drug candidates currently in development for a range of inflammatory dermatological conditions. The company's lead product candidate, topical roflumilast, has the potential to revitalize the standard of care for plaque psoriasis, atopic dermatitis, scalp psoriasis, and seborrheic dermatitis. For more information, visit https://www.arcutis.com or follow the company on LinkedIn and Twitter.

    Forward Looking Statements

    This press release contains "forward-looking" statements, including, among others, statements regarding roflumilast cream's potential as a treatment for atopic dermatitis; and expectations with regard to the timing of clinical data anticipated in the second half of 2022. 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, 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-Q filed with U.S. Securities and Exchange Commission (SEC) on November 5, 2020, as well as any subsequent filings with the SEC. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available.

    Investors and Media:

    Heather Rowe Armstrong

    Vice President, Investor Relations & Corporate Communications



    805-418-5006, Ext. 740



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  1. WESTLAKE VILLAGE, Calif., Jan. 11, 2021 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT), a late-stage biopharmaceutical company focused on developing and commercializing treatments for unmet needs in immune-mediated dermatological diseases and conditions, or immuno-dermatology, today announced that Matthew Moore has joined the company as Chief Business Officer. Mr. Moore brings to Arcutis over 20 years of strategy, transaction and operations experience in the biopharmaceutical industry. Most recently, he served as Vice President, Corporate Business Development and Alliance Management at Allergan, where he led worldwide strategy and business development for the company's $4B+ Medical Aesthetics business unit.

    "We are thrilled…

    WESTLAKE VILLAGE, Calif., Jan. 11, 2021 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT), a late-stage biopharmaceutical company focused on developing and commercializing treatments for unmet needs in immune-mediated dermatological diseases and conditions, or immuno-dermatology, today announced that Matthew Moore has joined the company as Chief Business Officer. Mr. Moore brings to Arcutis over 20 years of strategy, transaction and operations experience in the biopharmaceutical industry. Most recently, he served as Vice President, Corporate Business Development and Alliance Management at Allergan, where he led worldwide strategy and business development for the company's $4B+ Medical Aesthetics business unit.

    "We are thrilled to add Matt to our executive team. Like the rest of our senior team, Matt brings a deep understanding of dermatology markets, and he adds important expertise in corporate strategy, business development, and alliance management. His extensive experience creating shareholder value through successful business development will be a key enabler as we continue to build Arcutis into one of the industry's leading dermatology companies," said Frank Watanabe, Arcutis' President and Chief Executive Officer. "We at Arcutis are focused on elevating the standard of care for dermatological diseases, and his strategic insights and deal execution will play an important role in helping us to realize that goal."

    "I am delighted to join Arcutis at such an exciting time for the company," said Mr. Moore. "Arcutis has established itself as a leader in medical dermatology and is uniquely positioned to fill the innovation gap in this therapeutic area. I have been impressed by the pace of progress achieved to date, and look forward to working with the team to help make Arcutis the preeminent, innovation-driven medical dermatology company."

    During his tenure at Allergan and its predecessor companies, Actavis and Forest Labs, Mr. Moore was responsible for creating and executing business development growth strategies across multiple therapeutic areas including medical aesthetics, neuroscience, anti-infectives and hospital products. In addition, Mr. Moore served as a key deal team member in Actavis' transformational acquisition of Allergan and Allergan's ultimate sale to AbbVie. Prior to Allergan, Mr. Moore held executive roles at DOV Pharmaceutical and he started his career in the healthcare investment banking group at CIBC Oppenheimer. Mr. Moore earned his B.A. in Psychology from Trinity College.

    About Arcutis - Bioscience, applied to the skin.

    Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT) is a late-stage biopharmaceutical company focused on developing and commercializing treatments for unmet needs in immune-mediated dermatological diseases and conditions, or immuno-dermatology. The company is leveraging recent advances in immunology and inflammation to develop differentiated therapies against biologically validated targets to solve persistent treatment challenges in serious diseases of the skin. Arcutis' robust pipeline includes four novel drug candidates currently in development for a range of inflammatory dermatological conditions. The company's lead product candidate, topical roflumilast, has the potential to revitalize the standard of care for plaque psoriasis, atopic dermatitis, scalp psoriasis, and seborrheic dermatitis. For more information, visit https://www.arcutis.com or follow the company on LinkedIn and Twitter.

    Forward Looking Statements

    This press release contains "forward-looking" statements, including, among others, statements regarding the potential for Arcutis to become the preeminent, innovation-driven medical dermatology company. 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, 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-Q filed with U.S. Securities and Exchange Commission (SEC) on November 5, 2020, as well as any subsequent filings with the SEC. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available.

    Investors and Media:

    Heather Rowe Armstrong

    Vice President, Investor Relations & Corporate Communications



    805-418-5006, Ext. 740



    Primary Logo

    View Full Article Hide Full Article
  2. WESTLAKE VILLAGE, Calif., Dec. 21, 2020 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT), a late-stage biopharmaceutical company focused on developing and commercializing treatments for unmet needs in immune-mediated dermatological diseases and conditions, or immuno-dermatology, today announced that it has been selected for inclusion in the NASDAQ Biotechnology Index (NASDAQ:NBI), based on the results of the annual reconstitution of the index announced by Nasdaq on December 11, 2020. The inclusion will become effective prior to the U.S. market open on Monday, December 21, 2020.

    The NASDAQ Biotechnology Index is designed to track the performance of a set of securities listed on the NASDAQ Stock Market that are classified as…

    WESTLAKE VILLAGE, Calif., Dec. 21, 2020 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT), a late-stage biopharmaceutical company focused on developing and commercializing treatments for unmet needs in immune-mediated dermatological diseases and conditions, or immuno-dermatology, today announced that it has been selected for inclusion in the NASDAQ Biotechnology Index (NASDAQ:NBI), based on the results of the annual reconstitution of the index announced by Nasdaq on December 11, 2020. The inclusion will become effective prior to the U.S. market open on Monday, December 21, 2020.

    The NASDAQ Biotechnology Index is designed to track the performance of a set of securities listed on the NASDAQ Stock Market that are classified as either biotechnology or pharmaceutical companies, and is a modified market capitalization weighted index. According to NASDAQ, the NBI is reconstituted annually in December in accordance with a set of eligibility criteria including minimum market capitalization and average daily trading volume. The index currently has 198 securities as its components. For more information about the NBI, please visit https://indexes.nasdaqomx.com/index/overview/nbi.

    About Arcutis - Bioscience, applied to the skin.

    Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT) is a late-stage biopharmaceutical company focused on developing and commercializing treatments for unmet needs in immune-mediated dermatological diseases and conditions, or immuno-dermatology. The company is leveraging recent advances in immunology and inflammation to develop differentiated therapies against biologically validated targets to solve persistent treatment challenges in serious diseases of the skin. Arcutis' robust pipeline includes four novel drug candidates currently in development for a range of inflammatory dermatological conditions. The company's lead product candidate, topical roflumilast, has the potential to revitalize the standard of care for plaque psoriasis, atopic dermatitis, scalp psoriasis, and seborrheic dermatitis. For more information, visit www.arcutis.com or follow the company on LinkedIn and Twitter.

    Investors and Media:

    Heather Rowe Armstrong

    Vice President, Investor Relations & Corporate Communications



    805-418-5006, Ext. 740



    Primary Logo

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    • Broad and deep portfolio of highly differentiated product candidates aligned with needs of patients and doctors
    • Robust pipeline includes 4 development programs addressing 7 dermatological diseases, including 3 programs in Phase 2 or Phase 3 for 5 different indications
    • Pipeline has potential to generate sales of ~$3 billion to $8 billion by 2030 in the U.S. market alone
    • Live webcast and archived replay of Investor Day available in IR section of Arcutis website

    WESTLAKE VILLAGE, Calif., Dec. 09, 2020 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT), a late-stage biopharmaceutical company focused on developing and commercializing treatments for unmet needs in immune-mediated dermatological diseases and conditions, or immuno-dermatology…

    • Broad and deep portfolio of highly differentiated product candidates aligned with needs of patients and doctors
    • Robust pipeline includes 4 development programs addressing 7 dermatological diseases, including 3 programs in Phase 2 or Phase 3 for 5 different indications
    • Pipeline has potential to generate sales of ~$3 billion to $8 billion by 2030 in the U.S. market alone
    • Live webcast and archived replay of Investor Day available in IR section of Arcutis website

    WESTLAKE VILLAGE, Calif., Dec. 09, 2020 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT), a late-stage biopharmaceutical company focused on developing and commercializing treatments for unmet needs in immune-mediated dermatological diseases and conditions, or immuno-dermatology, today announced continued progress and future growth drivers related to its immuno-dermatology platform and pipeline, which will be highlighted during today's Virtual Investor Day at 11:00 am ET.

    The Virtual Investor Day features presentations and a Q&A session led by Arcutis executives, Frank Watanabe, President and Chief Executive Officer, Patrick Burnett, M.D., Ph.D., FAAD, Chief Medical Officer, and Kenneth Lock, Chief Commercial Officer. In addition, there will be commentary and Q&A with Zoe Diana Draelos, M.D., FAAD, consulting professor of dermatology, Duke University School of Medicine, Durham, N.C., and an investigator, Dermatology Consulting Services, High Point, N.C.

    The Investor Day will highlight multiple programs and markets illustrating the significant opportunity in Arcutis' portfolio and its value-creating potential:

    Substantial Market Opportunity

    • Large pool of currently treated and readily addressable patients;
    • Strong Phase 2 data across multiple indications, including plaque psoriasis, atopic dermatitis, seborrheic dermatitis, scalp psoriasis, and long-term treatment of psoriasis;
    • Compelling and differentiated product profile for topical roflumilast with efficacy equivalent to high potency steroids, rapid relief from itch, ability to use on all body areas with excellent safety and tolerability and convenient, once-a-day dosing in a easy to use cream or foam formulation; and
    • Pipeline that could generate sales of $3 billion to $8 billion by 2030 in the U.S. market alone.

    ARQ-151 - Topical Roflumilast Cream

    • Psoriasis long-term safety data shows a strong durability of efficacy and favorable safety/tolerability over 52 to 64 weeks, with a high patient completion rate; and
    • Investigator Global Assessment (IGA) success in atopic dermatitis at 4 weeks similar to other topicals.

    ARQ-154 - Topical Roflumilast Foam

    • Potential to be the first topical treatment in decades to offer a novel mechanism of action for the treatment of seborrheic dermatitis;
    • Psoriasis Scalp Investigator Global Assessment (S-IGA) success at 8 weeks similar to high potency steroids; and
    • Roflumilast may possess anti-fungal in addition to anti-inflammatory effects.

    ARQ-252 Cream & ARQ-255 Suspension (JAK1 Inhibitors)

    • ARQ-252/255 is highly selective to JAK1 over JAK2;
    • Among topical JAK inhibitors, ARQ-252/255 is the only treatment that is specific to JAK1;
    • Quick enrollment in Phase 2 hand eczema study with data expected in mid 2021, and Phase 2 vitiligo study starting soon; and
    • Novel "4D" deep-penetrating vehicle allowing topical delivery deep in the dermis where other topicals cannot reach.

    "We have a unique strategy that affords speed, capital efficiency and reduced risk, which enables us to leverage our unrivalled product development capabilities and expertise in dermatology drug development to address the significant unmet needs in dermatology," said Frank Watanabe, Arcutis' President and Chief Executive Officer. "Our team has built a broad and deep portfolio of unique and highly differentiated product candidates that we believe could generate as much as $8 billion in sales in the U.S. market alone. We are proud of this tremendous progress advancing and successfully executing on our strategy and positioning us to help dermatologists and their patients in the near future, and we look forward to providing updates on the upcoming flow of multiple Phase 2 and Phase 3 clinical catalysts expected in 2021 and 2022."

    Arcutis' virtual Investor Day is on Wednesday, Dec. 9, 2020, from 11:00 a.m.- 1:00 p.m. EST. A link to register for the event is available HERE. A live audio webcast and archived replay of the presentation will be available in the Investor Relations section of the Arcutis website.

    About Arcutis - Bioscience, applied to the skin.

    Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT) is a late-stage biopharmaceutical company focused on developing and commercializing treatments for unmet needs in immune-mediated dermatological diseases and conditions, or immuno-dermatology. The company is leveraging recent advances in immunology and inflammation to develop differentiated therapies against biologically validated targets to solve persistent treatment challenges in serious diseases of the skin. Arcutis' robust pipeline includes four novel drug candidates currently in development for a range of inflammatory dermatological conditions. The company's lead product candidate, topical roflumilast, has the potential to revitalize the standard of care for plaque psoriasis, atopic dermatitis, scalp psoriasis, and seborrheic dermatitis. For more information, visit www.arcutis.com or follow the company on LinkedIn and Twitter.

    Forward Looking Statements

    This press release contains "forward-looking" statements, including, among others, statements regarding the potential for its topical drugs in development to address large markets with significant unmet need; expectations with regard to the timing of data events and initiation of clinical trials anticipated during 2020/2021; and the Company's belief that its current cash, cash equivalents and marketable securities will be sufficient to fund its operations into 2022. 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, 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-Q filed with U.S. Securities and Exchange Commission (SEC) on November 5, 2020, as well as any subsequent filings with the SEC. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available.

    Investor Contact:

    Heather Rowe Armstrong

    Vice President, Investor Relations & Corporate Communications



    805-418-5006, Ext. 740

     



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