ARQT Arcutis Biotherapeutics Inc.

23.33
-0.32  -1%
Previous Close 23.65
Open 23.46
52 Week Low 17.51
52 Week High 38.49
Market Cap $1,171,283,723
Shares 50,205,046
Float 20,886,568
Enterprise Value $747,472,337
Volume 99,165
Av. Daily Volume 174,604
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Upcoming Catalysts

Drug Stage Catalyst Date
Roflumilast Cream (ARQ-151)
Plaque psoriasis
NDA Filing
NDA Filing
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Roflumilast foam (ARQ-154) - (STRATUM)
Seborrheic dermatitis
Phase 3
Phase 3
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Roflumilast foam (ARQ-154)
Scalp psoriasis
Phase 3
Phase 3
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Roflumilast Cream (ARQ-151) - (INTEGUMENT-1 and INTEGUMENT-2)
Atopic dermatitis
Phase 3
Phase 3
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Roflumilast Cream (ARQ-151) -INTEGUMENT-PED
Atopic Dermatitis - ages of 2-5 years old
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
ARQ-252
Vitiligo
Phase 2a
Phase 2a
Phase 2a trial to be terminated - noted July 1, 2021.
Roflumilast Cream (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-252
Chronic Hand Eczema
Phase 2b
Phase 2b
Phase 1/2b trial did not meet primary endpoint - May 4, 2021.

Latest News

    • The majority of patients with psoriasis have mild or moderate levels of disease
    • The new method, PASI-high discrimination (PASI-HD), is designed for use in clinical trials evaluating novel topical treatment options for psoriasis
    • Details of new approach published in Dermatology and Therapy

    WESTLAKE VILLAGE, Calif., July 21, 2021 (GLOBE NEWSWIRE) -- In order to address a major limitation of today's most widely used method for gauging severity of plaque psoriasis (the PASI scale), Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT), in conjunction with leading psoriasis experts, has developed a revised scale that offers greater precision for measuring disease extent and therapeutic effects in patients with mild-to-moderate disease. Arcutis, a late-stage…

    • The majority of patients with psoriasis have mild or moderate levels of disease

    • The new method, PASI-high discrimination (PASI-HD), is designed for use in clinical trials evaluating novel topical treatment options for psoriasis
    • Details of new approach published in Dermatology and Therapy

    WESTLAKE VILLAGE, Calif., July 21, 2021 (GLOBE NEWSWIRE) -- In order to address a major limitation of today's most widely used method for gauging severity of plaque psoriasis (the PASI scale), Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT), in conjunction with leading psoriasis experts, has developed a revised scale that offers greater precision for measuring disease extent and therapeutic effects in patients with mild-to-moderate disease. Arcutis, a late-stage biopharmaceutical company that champions meaningful innovation to address immune-mediated dermatological diseases and conditions, shared details of the new approach in the peer-reviewed scientific journal Dermatology and Therapy.

    "The majority of people affected by plaque psoriasis experience mild or moderate disease, yet clinicians lack the best possible tools to provide an accurate measurement of severity for those individuals," said Robert Higham, MPAS, PA-C, Executive Director of Clinical Development for Arcutis and one of the authors of the article. "As we work toward bringing topical treatment innovations for psoriasis to dermatologists and patients, we believe innovations are likewise needed to improve the tools and methods to properly diagnose and track all levels of disease and treatment effects."

    The article notes that disease severity is an essential outcome measure in clinical trials of new treatments for plaque psoriasis. However, the most common clinical measure to assess disease severity—the Psoriasis Area and Severity Index (PASI)—is geared toward more-severe levels of disease. To determine a PASI score, the area of body region affected by psoriasis is estimated and given a number, but for body areas with less than 10 percent of disease, a non-granular score of 1 is applied regardless of the actual extent of disease, masking any changes in disease extent between 0 and 9 percent.

    To address this shortcoming, Arcutis has introduced a key modification to PASI that more accurately measures severity and evaluates treatment effectiveness for areas of the body with mild-to-moderate levels of disease. The new method, PASI-high discrimination (PASI-HD), is designed to be used in clinical trials among patients for whom the areas of affected body surface within the anatomical regions measured by PASI are less than 10 percent.

    "Other alternatives to the PASI have been proposed in the past, but no other option preserves the anatomical component of the index by assessing the severity and percentage of area affected in the four body regions: head and neck, upper extremities, trunk, and lower extremities," said co-author Kim Papp, M.D., Ph.D., a Fellow of the Royal College of Physicians of Canada and Founder and President of Probity Medical Research Inc. Papp, a scientific advisor for Arcutis, also co-authored the journal article.

    In addition, PASI-HD more precisely captures disease flaring from and within areas with less than 10 percent of disease involvement.

    "Even mild or moderate psoriasis significantly impacts quality of life, and deserves focused attention from the medical dermatology community," said Patrick Burnett, M.D., Ph.D., FAAD, Chief Medical Officer of Arcutis. "As part of our mission to revitalize the standard of care for dermatological diseases, we believe it is necessary to remove the challenges that have traditionally hampered innovation for patients with skin diseases."

    In addition to Higham and Papp, authors of the article include colleagues at Arcutis and leading experts in the field of medical dermatology:

    • Mark Lebwohl, M.D., Professor and Chair of the Kimberly and Eric J. Waldman Department of Dermatology of the Icahn School of Medicine, Mount Sinai and Arcutis scientific advisor
    • Leon Kircik, M.D., Clinical Professor of Dermatology, Icahn School of Medicine, Mount Sinai, and Medical Director of DermResearch, PLLC, Physicians Skin Care, PLLC, and Skin Sciences
    • David Pariser, M.D., Senior Physician at Pariser Dermatology Specialists
    • Bruce Strober, M.D., Ph.D., Clinical Professor of Dermatology, Yale School of Medicine and Co-Founder of Central Connecticut Dermatology
    • Gerald Krueger, M.D., Dermatologist at University of Utah

    About Arcutis

    Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT) is a medical dermatology company that champions meaningful innovation to address the urgent needs of patients living with immune-mediated dermatological diseases and conditions. With a commitment to solving the most persistent patient challenges in dermatology, Arcutis harnesses our unique dermatology development platform coupled with our dermatology expertise to build differentiated therapies against biologically validated targets. Arcutis' dermatology development platform includes a robust pipeline with seven clinical programs for a range of inflammatory dermatological conditions, with our first NDA submission anticipated by the end of 2021 and three more Phase 3 clinical data readouts anticipated over the next 18 months. The company's lead product candidate, topical roflumilast, has the potential to advance the standard of care for plaque psoriasis, atopic dermatitis, scalp psoriasis, and seborrheic dermatitis. For more information, visit www.arcutis.com or follow Arcutis on LinkedIn and Twitter.



    Forward-Looking Statements

    This press release contains "forward-looking" statements, including, among others, statements regarding the potential for roflumilast to revolutionize the standard of care in plaque psoriasis and other inflammatory dermatological conditions. 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-K filed with U.S. Securities and Exchange Commission (SEC) on February 16, 2021, 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:

    Media Contact:

    Amanda Sheldon

    805.418.5006 x7116



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  1. Eleusis, a clinical-stage life science company dedicated to unlocking the full therapeutic potential of psychedelics, today announced the appointment of four highly experienced business leaders to its board of directors. The new directors' deep expertise building high-growth, high-impact life science companies complements Eleusis's world-class leadership team. The appointees include:

    • David Socks, former CEO of Phathom Pharmaceuticals, joining as Chair of the board
    • Robert Hershberg, M.D., Ph.D., former CBO and CSO of Celgene
    • John Tucker, CEO of SC Pharmaceuticals
    • Esther van den Boom, Managing Partner at van den Boom & Associates

    "We are delighted to welcome these four exceptional directors, who bring with them decades of experience…

    Eleusis, a clinical-stage life science company dedicated to unlocking the full therapeutic potential of psychedelics, today announced the appointment of four highly experienced business leaders to its board of directors. The new directors' deep expertise building high-growth, high-impact life science companies complements Eleusis's world-class leadership team. The appointees include:

    • David Socks, former CEO of Phathom Pharmaceuticals, joining as Chair of the board
    • Robert Hershberg, M.D., Ph.D., former CBO and CSO of Celgene
    • John Tucker, CEO of SC Pharmaceuticals
    • Esther van den Boom, Managing Partner at van den Boom & Associates

    "We are delighted to welcome these four exceptional directors, who bring with them decades of experience building successful therapeutics-focused life sciences companies," said Shlomi Raz, Eleusis's CEO and founder. "Our management team is thrilled to have these individuals help support and guide the company's effort to discover, develop, and deliver transformational psychedelic drug therapies to patients in urgent need of new treatment alternatives."

    "This is an opportune moment for Eleusis to push forward its vision of transforming psychedelics into modern medicines," said David Socks, Chair of the board. "On behalf of myself and my fellow directors, we are excited to be involved in a science-driven company that is pursuing a disciplined, thoughtful approach to transforming psychedelics into potential treatment options for patients with depression and other neuropsychiatric disorders, where there is significant unmet need."

    ELE-Psilo, the company's lead psychedelic drug candidate, is based on a proprietary, infusible form of psilocybin and is expected to enter clinical trials in early 2022. The company is also in the process of nationally scaling its innovative care delivery platform for psychedelic drug therapy to provide patients with affordable therapeutic alternatives for depression in a safe and caring environment.

    Board Appointments

    David Socks currently serves on the board of directors of Phathom Pharmaceuticals (NASDAQ:PHAT), where he was the founding CEO through the company's IPO. He also serves as a Venture Partner at Frazier Healthcare Partners, where he helps lead the firm's company creation efforts, co-founding companies such as Arcutis (NASDAQ:ARQT), Passage Bio (NASDAQ:PASG) and Scout Bio. Mr. Socks has also served as an advisor to Prometheus Bioscience (NASDAQ:RXDX) and PvP Biologics (acquired by Takeda). Previously, he was co-founder, President and COO of Incline Therapeutics (acquired by the Medicines Company) and co-founder and Senior Vice President, Corporate Development and Strategy of Cadence Pharmaceuticals (NASDAQ:CADX, acquired by Mallinckrodt))). Mr. Socks holds a B.S. from Georgetown University and an M.B.A from Stanford University.

    Robert Hershberg, M.D., Ph.D., is a Venture Partner on the life sciences team at Frazier Healthcare Partners. Dr. Hershberg previously served as President and Chief Executive Officer of VentiRx Pharmaceuticals, a Frazier-founded company that he led through its transformational partnership with Celgene. Mr. Hershberg then joined Celgene, where he was promoted to Chief Scientific Officer and subsequently to Chief Business Officer. Before VentiRx, he served as Senior Vice President and Chief Medical Officer of Dendreon Corporation and as Vice President of Medical Genetics at Corixa, a Frazier portfolio company. Earlier in his career, he was an Assistant Professor at Harvard Medical School and an Associate Physician at Brigham and Women's Hospital in Boston. Dr. Hershberg received his undergraduate and medical degrees from the University of California, Los Angeles, and his Ph.D. from the Salk Institute for Biological Studies.

    John H. Tucker is the Chief Executive Officer of scPharmaceuticals. Mr. Tucker previously served as Chief Executive Officer at Algal Scientific and Alcresta, where he led both companies through successful periods of strategic innovation and development. Throughout his career, he has held senior positions at multiple life sciences companies, including Incline Therapeutics, AMAG Pharmaceuticals, Basilea Pharmaceuticals and Indevus Pharmaceuticals. He also worked in a variety of hospital and retail-based sales and marketing roles at Ortho-McNeil Pharmaceuticals, ALZA Corporation, VIVUS and UCB Pharma. Mr. Tucker holds a B.A. from Plymouth State College and an M.B.A. from New Hampshire College.

    Esther van den Boom is Managing Partner of van den Boom & Associates and Chief Financial Officer of Tyra Biosciences. Ms. van den Boom has personally worked with over 50 life sciences companies throughout her career, partnering on various responsibilities including CFO, SOX 404 implementations, compliance and IPO assistance. Prior to founding van den Boom & Associates, she worked at Ernst & Young LLP as a Senior Manager in their San Diego office's audit practice. Ms. van den Boom received a B.A. in economics from the University of California, San Diego and an M.S. in accountancy from San Diego State University and is a licensed CPA.

    About Eleusis Ltd.

    Founded in 2013, Eleusis is a privately held, clinical-stage life science company dedicated to unlocking the full therapeutic potential of psychedelics, guided by science and enabled by drug discovery, clinical development and care delivery design. The company's comprehensive discovery, development and delivery capabilities enable it to target a broad spectrum of unmet needs within psychiatry, and beyond psychiatry. For more information, visit https://www.eleusisltd.com/.

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    • Topical roflumilast potential "Best-in-Class" topical PDE4 inhibitor
    • Seborrheic dermatitis affects 10 million patients in the U.S.
    • Potential first new topical treatment for seborrheic dermatitis in decades
    • The Company anticipates topline data in the second or third quarter of 2022

    WESTLAKE VILLAGE, Calif., July 12, 2021 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT), a late-stage biopharmaceutical company focused on developing meaningful innovations to address the urgent needs of patients living with immune-mediated dermatological diseases and conditions, or immuno-dermatology, today announced enrollment of the first patient in its single pivotal Phase 3 clinical trial evaluating topical roflumilast foam (ARQ-154) as a potential…

    • Topical roflumilast potential "Best-in-Class" topical PDE4 inhibitor

    • Seborrheic dermatitis affects 10 million patients in the U.S.
    • Potential first new topical treatment for seborrheic dermatitis in decades
    • The Company anticipates topline data in the second or third quarter of 2022

    WESTLAKE VILLAGE, Calif., July 12, 2021 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT), a late-stage biopharmaceutical company focused on developing meaningful innovations to address the urgent needs of patients living with immune-mediated dermatological diseases and conditions, or immuno-dermatology, today announced enrollment of the first patient in its single pivotal Phase 3 clinical trial evaluating topical roflumilast foam (ARQ-154) as a potential treatment for seborrheic dermatitis. Roflumilast foam is a once-daily topical foam formulation of roflumilast, a highly potent and selective phosphodiesterase type 4 (PDE4) inhibitor, which the Company is developing for seborrheic dermatitis and scalp psoriasis.

    "The symptoms of seborrheic dermatitis can have a significant, negative influence on quality of life and can cause psychological distress for millions of affected Americans. Despite that, no novel treatments have been developed for this chronic skin condition in decades, and current topical treatments frequently provide inadequate efficacy or pose safety concerns that limit their use," said Patrick Burnett, M.D., Ph.D., FAAD, Chief Medical Officer of Arcutis. "In our Phase 2 trial, roflumilast foam was demonstrated to be an effective, safe, and well-tolerated treatment for seborrheic dermatitis. We are now pleased to initiate this single Phase 3 pivotal trial, as we believe roflumilast foam, if approved, has the potential to become a much-needed new standard of care for people with seborrheic dermatitis. Unlike most treatments, roflumilast foam is suitable for all body areas, including hair-bearing areas and the face, and does not pose the safety concerns typically seen with topical steroids."

    The STudy of Roflumilast foam Applied Topically for the redUction of seborrheic derMatitis (STRATUM) is a Phase 3, parallel group, double blind, vehicle-controlled study of the safety and efficacy of roflumilast 0.3% foam administered once-daily in approximately 450 subjects ages nine and older with moderate to severe seborrheic dermatitis. The primary endpoint of the study is the proportion of subjects achieving Investigator Global Assessment (IGA) success, defined as an IGA score of "clear" or "almost clear" plus a 2-point improvement at eight weeks. The Company announced in January 2021 that it had conducted a successful End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) and planned to initiate a single pivotal Phase 3 trial in seborrheic dermatitis.

    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 Topical Roflumilast Foam

    Roflumilast foam is a once-daily, topical formulation of a highly potent and selective PDE4 inhibitor (roflumilast). The foam formulation was designed to treat hair-bearing areas of the body, such as the scalp, although it is usable in all areas of the body, including the face. 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 for dermatology. PDE4 is an intracellular enzyme that increases the production of pro-inflammatory mediators and decreases production of anti-inflammatory mediators; it has been implicated in a wide range of inflammatory diseases including psoriasis, atopic dermatitis, 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 and the systemic treatment of plaque psoriasis.



    About Arcutis

    Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT) is a medical dermatology company that champions meaningful innovation to address the urgent needs of patients living with immune-mediated dermatological diseases and conditions. With a commitment to solving the most persistent patient challenges in dermatology, Arcutis harnesses our unique dermatology development platform coupled with our dermatology expertise to build differentiated therapies against biologically validated targets.   Arcutis' dermatology development platform includes a robust pipeline with seven clinical programs for a range of inflammatory dermatological conditions, with our first NDA submission anticipated by the end of 2021 and three more Phase 3 clinical data readouts anticipated over the next 18 months. The company's lead product candidate, topical roflumilast, has the potential to advance the standard of care for plaque psoriasis, atopic dermatitis, scalp psoriasis, and seborrheic dermatitis. For more information, visit www.arcutis.com or follow Arcutis on LinkedIn and Twitter.



    Forward-Looking Statements

    This press release contains "forward-looking" statements, including, among others, statements regarding the potential for roflumilast to revolutionize the standard of care in seborrheic dermatitis and other inflammatory dermatological conditions. 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-K filed with U.S. Securities and Exchange Commission (SEC) on February 16, 2021, 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 and Media Contact:

     



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    • Formulation-related observations from ARQ-252 trial in chronic hand eczema informed early termination of Phase 2a ARQ-252 trial in vitiligo
    • Company progressing new formulation with goal of greater drug delivery to targets in the skin

    WESTLAKE VILLAGE, Calif., July 01, 2021 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT), today announced its decision to terminate the recently initiated Phase 2a clinical trial evaluating ARQ-252, a topical small molecule inhibitor of Janus kinase type 1 (JAK1), as a potential treatment for vitiligo (ARQ-252-213). Arcutis' decision is based on further analyses of the ARQ-252 drug formulation used in both this vitiligo study and the recently completed Phase 2b study evaluating ARQ-252 for the treatment…

    • Formulation-related observations from ARQ-252 trial in chronic hand eczema informed early termination of Phase 2a ARQ-252 trial in vitiligo

    • Company progressing new formulation with goal of greater drug delivery to targets in the skin

    WESTLAKE VILLAGE, Calif., July 01, 2021 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT), today announced its decision to terminate the recently initiated Phase 2a clinical trial evaluating ARQ-252, a topical small molecule inhibitor of Janus kinase type 1 (JAK1), as a potential treatment for vitiligo (ARQ-252-213). Arcutis' decision is based on further analyses of the ARQ-252 drug formulation used in both this vitiligo study and the recently completed Phase 2b study evaluating ARQ-252 for the treatment of chronic hand eczema (ARQ-252-205).

    As previously announced, the Phase 2b chronic hand eczema study did not meet its primary endpoint, with none of the ARQ-252 arms achieving statistical significance versus vehicle. Further analyses of that study pointed toward inadequate local drug delivery to the skin as a key driver of the lack of efficacy.

    "While we are disappointed to terminate this vitiligo study, we believe topical JAK inhibition remains a promising strategy for the treatment of both chronic hand eczema and vitiligo, and that ARQ-252 has potential as a new treatment for both diseases. Published clinical data for other topical JAK inhibitors have shown encouraging results in both indications. Furthermore, the active pharmaceutical ingredient in ARQ-252 -- SHR0302 -- is a potent and highly selective JAK1 inhibitor that has demonstrated efficacy and safety as an investigational oral formulation in other inflammatory conditions such as rheumatoid arthritis and atopic dermatitis," said Patrick Burnett, M.D., Ph.D., FAAD, Chief Medical Officer of Arcutis. "We have already made good progress in reformulating ARQ-252 to potentially deliver much more active drug to targets in the skin and hope to re-enter the clinic with this reformulated version in the not-too-distant future. We want to thank the patients and investigators in the vitiligo study for their participation."

    The vitiligo study is not being terminated for any safety or tolerability reasons. ARQ-252 has been safe and well-tolerated, and no unexpected safety concerns have been identified.

    About ARQ-252

    ARQ-252 is a small molecule inhibitor of Janus kinase type 1 (JAK1). Many inflammatory cytokines and other signaling molecules rely on the JAK pathway, and specifically JAK1, which plays a central role in immune system function. Inhibition of JAK1 has been shown to treat a range of inflammatory diseases, including rheumatoid arthritis, Crohn's disease, and atopic dermatitis. The Company believes that due to its high selectivity for JAK1 over JAK2, ARQ-252 has the potential to effectively treat inflammatory diseases without causing the hematopoietic adverse effects typically associated with JAK2 inhibition. In 2018, Arcutis exclusively licensed the active pharmaceutical ingredient in ARQ-252 for all topical dermatological uses in the United States, Europe, Japan and Canada from Jiangsu Hengrui Medicine Co., Ltd. of China. In mid-2019, Hengrui completed a Phase 2b study in rheumatoid arthritis that used the same active pharmaceutical ingredient as in ARQ-252 but dosed orally. The results confirmed that this active pharmaceutical ingredient is a highly potent inhibitor of JAK1 based on the drug's impact on rheumatoid arthritis, and was generally well tolerated at exposures well above those expected with topical administration of ARQ-252 in patients with chronic hand eczema. In 2020, Reistone Biopharma, a subsidiary of Hengrui, announced positive topline results from a Phase 2 clinical trial evaluating the oral version of the active ingredient in ARQ-252 for the treatment of moderate-to-severe atopic dermatitis. Reistone Biopharma is also studying the oral formulation as a potential treatment for alopecia areata, Crohn's disease, and ulcerative colitis.



    About Arcutis

    Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT) is a medical dermatology company that champions meaningful innovation to address the urgent needs of patients living with immune-mediated dermatological diseases and conditions. With a commitment to solving the most persistent patient challenges in dermatology, Arcutis harnesses our unique dermatology development platform coupled with our dermatology expertise to build differentiated therapies against biologically validated targets. Arcutis' dermatology development platform includes a robust pipeline with seven clinical programs for a range of inflammatory dermatological conditions, with our first NDA submission by the end of 2021 and three more Phase 3 clinical data readouts anticipated over the next 18 months. The company's lead product candidate, topical roflumilast, has the potential to advance the standard of care for plaque psoriasis, atopic dermatitis, scalp psoriasis, and seborrheic dermatitis. For more information, visit www.arcutis.com or follow Arcutis on LinkedIn and Twitter.



    Forward-Looking Statements

    This press release contains "forward-looking" statements, including, among others, statements regarding the potential for Arcutis to conduct clinical trials with a reformulated ARQ-252 and for the reformulated product to treat chronic hand eczema and vitiligo. 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-K filed with U.S. Securities and Exchange Commission (SEC) on February 16, 2021, 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 and Media Contact:





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  2. WESTLAKE VILLAGE, Calif., June 23, 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 Greg Sukay has joined the company as Vice President, Manufacturing and Process Technologies. Mr. Sukay, who brings more than 25 years of experience in biopharmaceutical operations, will oversee Arcutis' external manufacturing and process development for its pipeline of medical dermatology programs.

    "We welcome Greg at an exciting time for our company, as we advance closer than ever to bringing our novel products to patients with…

    WESTLAKE VILLAGE, Calif., June 23, 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 Greg Sukay has joined the company as Vice President, Manufacturing and Process Technologies. Mr. Sukay, who brings more than 25 years of experience in biopharmaceutical operations, will oversee Arcutis' external manufacturing and process development for its pipeline of medical dermatology programs.

    "We welcome Greg at an exciting time for our company, as we advance closer than ever to bringing our novel products to patients with immune-driven skin disorders," said Frank Watanabe, Arcutis' President and Chief Executive Officer. "With his extensive background in product development, operations, and manufacturing, Greg will be an integral leader as we scale our programs to a commercial stage, especially in preparation for the anticipated launch of topical roflumilast."

    Topical roflumilast, Arcutis' lead product candidate, is being studied in cream and foam formulations as a potential transformative treatment for chronic plaque psoriasis, atopic dermatitis, scalp psoriasis, and seborrheic dermatitis.

    "I am honored to join Arcutis at such a significant stage and to play a role in bringing the company's vision to life," Mr. Sukay said. "Topical roflumilast is just the first example of how we are moving forward with our mission to revitalize the standard of care for dermatological diseases. Through state-of-the-art manufacturing and process development, I look forward to helping bring innovative new therapies to patients in need."

    Prior to joining Arcutis, Mr. Sukay spent more than 22 years at Amgen, where he most recently served as Executive Director of Amgen Contract Manufacturing, overseeing a global multi-million dollar contract manufacturing network. He also spent six years as Plant Manager and Executive Director of Amgen Singapore. He holds over 25 years of drug development experience in various roles, including director of process development and principal engineer. Greg earned his B.S. in Chemical Engineering from Purdue University.



    About Arcutis

    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 roflumilast to revolutionize the standard of care in plaque psoriasis and other inflammatory dermatological conditions. 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-K filed with U.S. Securities and Exchange Commission (SEC) on February 16, 2021, 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 and Media Contact:



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