ARQT Arcutis Biotherapeutics Inc.

21.51
-0.27  -1%
Previous Close 21.78
Open 21.85
52 Week Low 17.51
52 Week High 38.49
Market Cap $1,080,705,906
Shares 50,241,789
Float 20,923,311
Enterprise Value $691,547,418
Volume 26,998
Av. Daily Volume 154,278
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Upcoming Catalysts

Drug Stage Catalyst Date
Roflumilast foam (ARQ-154) - (STRATUM)
Seborrheic dermatitis
Phase 3
Phase 3
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Roflumilast foam (ARQ-154) - (ARRECTOR)
Scalp psoriasis
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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Roflumilast Cream (ARQ-151) - (INTEGUMENT-1 and INTEGUMENT-2)
Atopic dermatitis
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
Roflumilast Cream (ARQ-151) - (DERMIS-1)
Plaque psoriasis
NDA Filing
NDA Filing
NDA filed October 4, 2021.
Roflumilast Cream (ARQ-151) - DERMIS-2
Plaque psoriasis
Phase 3
Phase 3
Phase 3 data met its primary endpoint of Investigator Global Assessment Success rate at week 8 in 37.5% compared to a vehicle rate of 6.9%, noted September 30, 2021.
ARQ-252
Vitiligo
Phase 2a
Phase 2a
Phase 2a trial to be terminated - noted July 1, 2021.
ARQ-252
Chronic Hand Eczema
Phase 2b
Phase 2b
Phase 1/2b trial did not meet primary endpoint - May 4, 2021.

Latest News

    • Plaque psoriasis is a skin disease that affects approximately 8.6 million individuals in the U.S. and presents particular treatment challenges in certain anatomical regions.
    • Roflumilast cream, a non-steroidal treatment intended for chronic use, would be the first and only topical PDE4 inhibitor for psoriasis, if approved.
    • Roflumilast cream demonstrated statistically significant superiority over vehicle on the primary endpoint of IGA Success and statistically significant improvements in multiple secondary endpoints in pivotal Phase 3 studies.
    • Roflumilast cream was generally well-tolerated with a favorable safety and tolerability profile.

    WESTLAKE VILLAGE, Calif., Oct. 04, 2021 (GLOBE NEWSWIRE) --  Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT

    • Plaque psoriasis is a skin disease that affects approximately 8.6 million individuals in the U.S. and presents particular treatment challenges in certain anatomical regions.
    • Roflumilast cream, a non-steroidal treatment intended for chronic use, would be the first and only topical PDE4 inhibitor for psoriasis, if approved.
    • Roflumilast cream demonstrated statistically significant superiority over vehicle on the primary endpoint of IGA Success and statistically significant improvements in multiple secondary endpoints in pivotal Phase 3 studies.
    • Roflumilast cream was generally well-tolerated with a favorable safety and tolerability profile.

    WESTLAKE VILLAGE, Calif., Oct. 04, 2021 (GLOBE NEWSWIRE) --  Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT), a late-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology to address the urgent needs of patients living with immune-mediated dermatological diseases and conditions, today announced it has submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for roflumilast cream for the treatment of mild-to-severe plaque psoriasis.

    Roflumilast cream (ARQ-151) is a once-daily topical formulation of roflumilast, a highly potent and selective inhibitor of phosphodiesterase type 4 (PDE4), an enzyme that drives overactive immune responses. In clinical trials, roflumilast cream demonstrated robust efficacy coupled with favorable safety and tolerability that, if approved, would enable chronic use across the body, without many of the local tolerability issues associated with alternative treatments.

    "Today is a critical milestone for Arcutis in our efforts to bring innovative treatments to dermatologists and their patients, and is a reflection of our deep dermatology expertise," said Frank Watanabe, President and CEO of Arcutis. "Individuals with plaque psoriasis currently do not have topical treatment options that offer a combination of good tolerability and the ability to be used for long periods of time, and that can be used on all parts of the body. If approved, roflumilast cream will be the first and only topical PDE4 inhibitor approved for psoriasis and an important non-steroidal treatment option for the millions of individuals struggling with plaque psoriasis. I want to thank the Arcutis team, as well as the clinical investigators, patients, and partners, for helping us reach this important milestone."

    Psoriasis is a common, non-contagious, immune-mediated skin disease that affects more than 3% of the U.S. population. The majority of patients develop "plaques," or raised, red areas of skin covered with a silver or white layer of dead skin cells. Psoriatic plaques are often itchy and sometimes painful, and can appear on any area of the body. Plaques in certain anatomical areas present particular treatment challenges, including the face, elbows and knees, scalp, and areas where two skin areas may touch or rub together.

    Topical treatments are the mainstay of therapy for the vast majority of psoriasis patients, particularly those with mild-to-moderate disease, as well as many moderate-to-severe patients who use topicals in combination with other treatments. However, existing topical treatments often force physicians and patients to make difficult trade-offs between tolerability and long-term use, requiring the use of multiple products or complicated treatment schedules. Roflumilast cream has been designed to address the challenges posed to dermatologists and patients by existing topical therapies and aims to simplify the overall management of plaque psoriasis.

    Arcutis' submission is supported by positive data from Arcutis' pivotal Phase 3 program. The DERMIS 1 and DERMIS 2 (Trials of PDE4 inhibition with Roflumilast for the Management of plaque PsoriasIS" One and Two) were identical Phase 3 randomized, parallel, double-blind, vehicle-controlled, multi-national, multi-center studies to evaluate the safety and efficacy of roflumilast cream 0.3%. Roflumilast met its primary endpoint and had an ‘IGA Success' rate of 42.4% compared to a vehicle rate of 6.1% (P<0.0001), and 37.5% compared to a vehicle rate of 6.9% (P<0.0001), in DERMIS 1 and 2 respectively. Roflumilast cream 0.3% also demonstrated statistically significant improvements over vehicle on key secondary endpoints, including on Intertriginous IGA (I-IGA) Success, Psoriasis Area Severity Index-75 (PASI-75), reductions in itch as measured by the Worst Itch-Numerical Rating Scale (WI-NRS), and patient perceptions of symptoms as measured by the Psoriasis Symptoms Diary (PSD). In trials, roflumilast cream was generally well-tolerated with a favorable safety and tolerability profile.



    About 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

    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 multiple clinical programs for a range of inflammatory dermatological conditions, with one NDA submission now under review with the FDA and three Phase 3 clinical data readouts anticipated by the end of 2022. The company's lead program, 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 be approved for the treatment of adults and adolescents with plaque psoriasis, the potential to use roflumilast cream over a long period of time, or chronically, and 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.

    Contacts:

    Media

    Amanda Sheldon, Head of Corporate Communications

    asheldon@arcutis.com

    Investors

    Eric McIntyre, Head of Investor Relations

    emcintyre@arcutis.com



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    • Topical roflumilast provided significant improvements in severity and burden of itch in Phase 3 plaque psoriasis studies, as well as Phase 2 studies in seborrheic dermatitis and scalp and body psoriasis.
    • Quality of life improvements were achieved starting as early as week two
    • Pivotal studies support potential use of roflumilast cream as effective and well-tolerated non-steroidal topical therapy for plaque psoriasis

    WESTLAKE VILLAGE, Calif., Sept. 30, 2021 (GLOBE NEWSWIRE) --  Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT), a late-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology to address the urgent needs of patients living with immune-mediated dermatological diseases and conditions, today announced…

    • Topical roflumilast provided significant improvements in severity and burden of itch in Phase 3 plaque psoriasis studies, as well as Phase 2 studies in seborrheic dermatitis and scalp and body psoriasis.
    • Quality of life improvements were achieved starting as early as week two
    • Pivotal studies support potential use of roflumilast cream as effective and well-tolerated non-steroidal topical therapy for plaque psoriasis

    WESTLAKE VILLAGE, Calif., Sept. 30, 2021 (GLOBE NEWSWIRE) --  Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT), a late-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology to address the urgent needs of patients living with immune-mediated dermatological diseases and conditions, today announced new patient-reported outcome data that show topical roflumilast provides significant reductions in itch, a common and bothersome symptom of multiple dermatologic conditions. Once-daily roflumilast cream reduced both the severity and burden of itch, and improved quality of life, in the DERMIS-1 and DERMIS-2 Phase 3 pivotal studies in chronic plaque psoriasis. In addition, in two separate Phase 2 studies, topical roflumilast foam showed a robust and rapid reduction of itch in scalp and body psoriasis and seborrheic dermatitis. These data were presented at the annual European Academy of Dermatology and Venereology (EADV) Congress (Sept 29 – Oct 2).

    "Itch is the most frequently reported symptom associated with dermatologic conditions such as plaque psoriasis, scalp psoriasis and seborrheic dermatitis, severely impacting patients' quality of life. These robust and consistent data across multiple indications demonstrate that topical roflumilast significantly improved both the severity and burden of itch, that symptoms improved quickly and continued improving through the course of treatment," said Patrick Burnett, M.D., Ph.D., FAAD, Chief Medical Officer of Arcutis. "Meaningfully impacting symptoms that matter most to patients, such as itch, is at the core of Arcutis' mission. Topical roflumilast continues to demonstrate strong efficacy with a safety and tolerability profile that, if approved, should enable chronic use and the ability to use across the body."

    Dr. Melinda J. Gooderham presented patient-reported outcome data from the DERMIS studies in patients with chronic plaque psoriasis treated with roflumilast cream that showed the mean reduction in Worst-Itch Numeric Rating Scale (WI-NRS) score was significantly greater with roflumilast cream than vehicle at all study timepoints, with improvements achieved as early as two weeks (mean change from baseline of -3.7 and -4.0 for roflumilast cream; -1.4 and -1.7 for vehicle; P<0.0001). In addition, more than two-thirds of patients with a WI-NRS of four or greater at baseline achieved a reduction of four-points or more with roflumilast cream compared to less than one-third of individuals using vehicle at week 8 (67.5% and 69.4% of patients using roflumilast cream compared to 26.8% and 35.6% using vehicle; P<0.0001). Overall quality of life was also improved with the use of once-daily roflumilast cream as measured by the Dermatology Life Quality Index (DLQI) with an improvement of 65.2% from baseline in the DLQI score for roflumilast cream vs 12.7% vehicle in DERMIS-1 and a 69.4% improvement from baseline DLQI score roflumilast cream vs 9.0% vehicle in DERMIS-2 (P<0.0001).

    In a separate poster presentation highlighting results from the Phase 2 randomized, double-blind, vehicle-controlled study of roflumilast foam in patients with plaque psoriasis on the scalp and body, 68.2% of patients with a WI-NRS score of four or greater at baseline using roflumilast foam achieved a four point or greater reduction in WI-NRS compared to only 23.1% of patients using vehicle at week eight. These results are consistent with that observed specifically in the scalp with 71.0% of patients with a baseline Scalp Itch (SI)-NRS of four or greater at baseline achieving a four-point or greater improvement in SI-NRS as compared to 18.5% in the vehicle treated group.

    Likewise, data presented in a poster presentation from a Phase 2 study of patients with seborrheic dermatitis showed approximately 64.6% of patients with a WI-NRS score of four or greater at baseline using roflumilast foam achieved a four point or greater reduction in WI-NRS compared to only 34.0% of patients using vehicle at week eight.

    In these studies, both roflumilast cream and roflumilast foam met their primary endpoints and were generally well-tolerated.

    • Roflumilast cream 0.3% met its primary endpoint of Investigator Global Assessment Success rate at week 8 in 42.4% patients compared to a vehicle rate of 6.1% (P<0.0001), and 37.5% compared to a vehicle rate of 6.9% (P<0.0001), in the Phase 3 studies DERMIS-1 and DERMIS-2 respectively (Trials of PDE4 inhibition with Roflumilast for the Management of plaque PsoriasIS" One and Two)
    • Roflumilast foam met its primary endpoint in the Phase 2 Scalp and Body study with a Scalp-Investigator Global Assessment success rate of 59.1% patients compared to a vehicle rate of 11.4% (P<0.0001). Of these, 34.3% of patients on roflumilast foam achieved a status of clear.
    • Roflumilast foam met its primary endpoint in the Phase 2 seborrheic dermatitis study with 73.8% of roflumilast treated patients achieving IGA success at week 8 vs 40.9% of vehicle-treated patients (P<0.0001). Additionally, 35.5% of patients using roflumilast foam achieved an IGA status of clear at week 8 vs 15.2% of vehicle-treated patients.

    About Topical Roflumilast

    Arcutis is developing topical cream and foam formulations of roflumilast – a highly potent and selective phosphodiesterase-4 (PDE4) inhibitor being investigated as a once-daily, nonsteroidal, topical treatment for multiple dermatologic conditions. 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

    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 late in the third quarter or early in the fourth quarter of 2021 and three more Phase 3 clinical data readouts anticipated by the end of 2022. 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.

    Contacts:

    Media

    Amanda Sheldon, Head of Corporate Communications

    asheldon@arcutis.com

    Investors

    Eric McIntyre, Head of Investor Relations

    emcintyre@arcutis.com 



    Primary Logo

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  1. WESTLAKE VILLAGE, Calif., Sept. 28, 2021 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT), a late-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology to address the urgent needs of patients living with immune-mediated dermatological diseases and conditions, today announced a new patent issued by the United States Patent and Trademark Office covering its invention for improving delivery and extending half-life of both the cream and foam formulations of topical roflumilast.

    Arcutis is developing topical cream and foam formulations of roflumilast, a highly potent and selective phosphodiesterase type 4 inhibitor (PDE4), to treat psoriasis, atopic dermatitis, and seborrheic dermatitis…

    WESTLAKE VILLAGE, Calif., Sept. 28, 2021 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT), a late-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology to address the urgent needs of patients living with immune-mediated dermatological diseases and conditions, today announced a new patent issued by the United States Patent and Trademark Office covering its invention for improving delivery and extending half-life of both the cream and foam formulations of topical roflumilast.

    Arcutis is developing topical cream and foam formulations of roflumilast, a highly potent and selective phosphodiesterase type 4 inhibitor (PDE4), to treat psoriasis, atopic dermatitis, and seborrheic dermatitis. Clinical trial data has shown that Arcutis' topical roflumilast formulations are uniquely suited to address unmet patient needs without difficult trade-offs between efficacy, safety, and tolerability.

    "We believe this new patent represents important additional protection for our unique, proprietary topical roflumilast treatment, and is separate and distinct from our formulation patents. While we believe our issued and pending formulation patents provide substantial protection for topical roflumilast, having this additional patent covering the unique pharmacokinetic characteristics of our treatment is meaningful additional protection," said Frank Watanabe, Arcutis' President and Chief Executive Officer. "This new patent also further validates Arcutis' dermatological development platform that builds on our deep dermatological expertise, which includes one of the foremost topical formulators and five dermatology clinicians on staff. With eight issued patents and additional pending patents, we expect patent protection at least into 2037."

    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 late in the third quarter or early in the fourth quarter of 2021, and three more Phase 3 clinical data readouts anticipated by the end of 2022. 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.

    Contacts:

    Media

    Amanda Sheldon, Head of Corporate Communications

    805-418-5006

    asheldon@arcutis.com

    Investors

    Eric McIntyre, Head of Investor Relations

    805-418-5006

    emcintyre@arcutis.com

     



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  2. WESTLAKE VILLAGE, Calif., Sept. 27, 2021 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT), a late-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology to address the urgent needs of patients living with immune-mediated dermatological diseases and conditions, today announced that four abstracts for Arcutis' topical roflumilast program in psoriasis, scalp and body psoriasis, and seborrheic dermatitis will be presented at European Academy of Dermatology and Venereology (EADV) Congress. Topical roflumilast is a selective and highly potent phosphodiesterase-4 inhibitor being investigated by Arcutis as a non-steroidal topical treatment for multiple inflammatory skin diseases.

    "Data continue…

    WESTLAKE VILLAGE, Calif., Sept. 27, 2021 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT), a late-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology to address the urgent needs of patients living with immune-mediated dermatological diseases and conditions, today announced that four abstracts for Arcutis' topical roflumilast program in psoriasis, scalp and body psoriasis, and seborrheic dermatitis will be presented at European Academy of Dermatology and Venereology (EADV) Congress. Topical roflumilast is a selective and highly potent phosphodiesterase-4 inhibitor being investigated by Arcutis as a non-steroidal topical treatment for multiple inflammatory skin diseases.

    "Data continue to demonstrate that topical roflumilast delivers superior efficacy over vehicle across multiple indications while improving the severity and impact of itch," said Patrick Burnett, M.D., Ph.D., FAAD, Chief Medical Officer, Arcutis. "We are proud of the strength of our drug development platform, as demonstrated here with multiple presentations from our DERMIS pivotal trials in psoriasis, as well as Phase 2 data in seborrheic dermatitis, and scalp and body psoriasis."

    New data from the DERMIS-1 and DERMIS-2 Phase 3 pivotal trial will be presented in the following oral presentation:

    Title: Roflumilast Cream 0.3% Improved the Severity and Impact of Itch in Patients with Chronic Plaque Psoriasis in the Phase 3 DERMIS-1 and DERMIS-2 Studies

    Presenting Author: Dr. Melinda J. Gooderham

    Time: 2:50 – 3:00 pm CEST/ 8:50 – 9:00 am EDT

    Location: Room 13

    The presentation will include patient-reported outcomes, including itch, which patients with plaque psoriasis report as the most burdensome symptom.

    In addition, the following posters will be electronically available for the entirety of the conference:

    Title: Once-Daily Roflumilast Cream 0.3%, a Potent Phosphodiesterase-4 Inhibitor, Provided Safe and Effective Treatment of Psoriasis in the DERMIS-1 and DERMIS-2 Phase 3 Trials

    Presenting Author: Dr. Mark Lebowohl

    Title: Once-daily Roflumilast Foam 0.3% Improves Severity and Burden of Itch in Patients with Scalp and Body Psoriasis in a Randomized, Double-blind, Vehicle-controlled Phase 2b Study

    Presenting Author: Dr Angela Y. Moore

    Title: Randomized, Double-blind, Vehicle-controlled Phase 2a Study Evaluating Once Daily Roflumilast Foam 0.3% in Patients with Moderate to Severe Seborrheic Dermatitis

    Presenting Author: Dr. Matthew Zirwas

    About Topical Roflumilast

    Arcutis is developing topical cream and foam formulations of roflumilast – a highly potent and selective phosphodiesterase-4 (PDE4) inhibitor being investigated as a once-daily, nonsteroidal, topical treatment for multiple dermatologic conditions. 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

    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 late in the third quarter or early in the fourth quarter of 2021 and three more Phase 3 clinical data readouts anticipated by the end of 2022. 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.

    Contacts:

    Media

    Amanda Sheldon, Head of Corporate Communications

    (805) 418-5006

    asheldon@arcutis.com

    Investors

    Eric McIntyre, Head of Investor Relations

    (805) 418-5006

    emcintyre@arcutis.com

     



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  3. WESTLAKE VILLAGE, Calif., Sept. 09, 2021 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT), a late-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology to address the urgent needs of patients living with immune-mediated dermatological diseases and conditions, today announced that Arcutis management will participate in two upcoming investor conferences in September.

    Details for the company's participation are as follows:

    • Morgan Stanley 19th Annual Global Healthcare Conference
      Fireside Chat Date: Wednesday, September 15, 2021
      Fireside Chat Time: 10:15 a.m. EDT
    • Cantor Virtual Global Healthcare Conference
      Fireside Chat Date: Monday, September 27, 2021
      Fireside Chat Time:

    WESTLAKE VILLAGE, Calif., Sept. 09, 2021 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT), a late-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology to address the urgent needs of patients living with immune-mediated dermatological diseases and conditions, today announced that Arcutis management will participate in two upcoming investor conferences in September.

    Details for the company's participation are as follows:

    • Morgan Stanley 19th Annual Global Healthcare Conference

      Fireside Chat Date: Wednesday, September 15, 2021

      Fireside Chat Time: 10:15 a.m. EDT
    • Cantor Virtual Global Healthcare Conference

      Fireside Chat Date: Monday, September 27, 2021

      Fireside Chat Time: 11:20 a.m. EDT

    Webcasts for these conferences may be accessed at the "Events & Presentations" section of the Company's Investor website at https://investors.arcutis.com/events-and-presentations. Additionally, a replay of the webcasts will be available on the Arcutis website following the conferences.

    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 late in the third quarter or early in the fourth quarter of 2021 and three more Phase 3 clinical data readouts anticipated by the end of 2022. 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.

    Contacts:

    Media

    Amanda Sheldon, Head of Corporate Communications

    (805) 418-5006

    asheldon@arcutis.com

    Investors

    Eric McIntyre, Head of Investor Relations

    (805) 418-5006

    emcintyre@arcutis.com



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