Arcutis Biotherapeutics

Arcutis Biotherapeutics, Inc. engages in the development and commercialization of treatments for dermatological diseases. Its pipeline consists of topical treatments for plaque psoriasis, atopic dermatitis, hand eczema, vitiligo, scalp psoriasis, alopecia areata, and seborrheic dermatitis. The company was founded by Bhaskar Chaudhuri and David W. Osborne in June 2016 and is headquartered in Westlake Village, CA.

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Arcutis Biotherapeutics reports successful 2022 performance and growth strategies

Arcutis Biotherapeutics showcased strong performance in 2022, with ZORYVE's success and pipeline progress driving revenue growth. The company's strategic focus on non-steroidal treatments aligns with changing standards of care and patient preferences. Challenges in maintaining gross-to-net and competition comparisons are areas of focus for sustainable growth.

Arcutis Biotherapeutics reports strong Q1 performance and growth opportunities

Arcutis Biotherapeutics showcased strong performance in Q1 2023, driven by ZORYVE's growth and expanding commercial coverage.
Despite challenges with gross-to-net dynamics and operational issues, the company remains confident in demand growth and product feedback.
Strategic initiatives focusing on market penetration, education, and partnerships position Arcutis well for future growth and product success.
Expansion into Canada, pricing strategy alignment, and disease awareness efforts offer promising opportunities for market expansion and acceptance.

Arcutis Biotherapeutics excels in Q2 with ZORYVE's growth and market expansion

Arcutis Biotherapeutics delivered a strong Q2 performance driven by ZORYVE's successful launch and coverage expansion, positioning the company for continued growth in Q3 and Q4.
Despite facing challenges in physician adoption and managing expenses, Arcutis benefits from key strengths like broad market access, positive physician feedback, and a robust patent estate.
With opportunities to capitalize on key payer agreements, expand into new indications, and drive market differentiation, Arcutis is poised for strategic growth and market expansion in the dermatology sector.

Arcutis Biotherapeutics excels in Q3, eyes market expansion opportunities

Arcutis Biotherapeutics showcased strong financial performance and key achievements in Q3 2023.
The successful ZORYVE launch and positive Phase III data highlight growth potential.
Strategic partnerships and market expansion plans position the company for future success.
Efforts to drive ZORYVE utilization and navigate market challenges are key focus areas.

Arcutis Biotherapeutics excels in Q4, poised for market expansion

Arcutis Biotherapeutics delivered strong financial performance and market acceptance in Q4 2023.
The company's focus on expanding its product portfolio and market reach bodes well for future growth.
Challenges in coverage negotiations and patient engagement require strategic solutions for sustained success.
Overall, Arcutis is well-positioned to capitalize on market opportunities and drive continued growth.

Arcutis Biotherapeutics reports strong Q1 performance and eyes market expansion

Arcutis Biotherapeutics anticipates sustained growth in 2024 and beyond, aiming to positively impact patients with chronic dermatologic diseases.
The company's focus on partnerships, market access optimization, and product expansion positions them well for future success in the dermatology market.
Despite challenges such as regulatory milestones and partnership negotiations, Arcutis remains confident in their ability to navigate these hurdles and drive continued growth.

Arcutis Biotherapeutics excels in Q2 2024, poised for growth

Arcutis Biotherapeutics delivered a strong performance in Q2 2024, driven by the success of ZORYVE products and strategic financial management.
While facing challenges in market expansion and operational efficiency, the company's focus on growth opportunities and profitability strategies bode well for future success.
Overall, Arcutis Biotherapeutics remains well-positioned to capitalize on market opportunities, expand product reach, and drive sustained revenue growth.

Arcutis Biotherapeutics excels in Q3, eyes growth through partnerships

Arcutis Biotherapeutics demonstrated strong sales growth, improved market access, and product label expansions in Q3 2024, positioning the company for future success.
While challenges like achieving breakeven and optimizing partnerships exist, opportunities from upcoming approvals and market trends present avenues for sustained growth.
Overall, Arcutis Biotherapeutics' strategic initiatives and performance in Q3 underscore its potential for long-term success and market leadership in dermatology.

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WESTLAKE VILLAGE, Calif., April 18, 2023 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early commercial-stage company focused on developing meaningful innovations in immuno-dermatology, today announced the U.S. Food and Drug Administration (FDA) has accepted for review the company's new drug application (NDA) for roflumilast foam 0.3% for the treatment of seborrheic dermatitis in individuals 9 years of age and older. The application was assigned a Prescription Drug User Fee Act (PDUFA) target action date of December 16, 2023.

Arcutis Announces FDA Acceptance of New Drug Application for Roflumilast Foam 0.3% for the Treatment of Seborrheic Dermatitis in Individuals Aged 9 Years and Older

WESTLAKE VILLAGE, Calif., April 05, 2023 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early commercial-stage company focused on developing meaningful innovations in immuno-dermatology, today announced that ZORYVE® (roflumilast) cream 0.3% for the treatment of plaque psoriasis, including intertriginous psoriasis, in adults and adolescents is being covered without prior authorizations by an additional eight national and regional health plans effective April 1. Combined with the previously announced coverage from two of the three largest national pharmacy benefit managers and several large national health plans, commercial coverage for ZORYVE for plaque psoriasis now exceeds 110 million commercially covered lives in the United States.

Arcutis Announces New Coverage for ZORYVE® (Roflumilast) Cream 0.3% with National and Regional Health Plan Formularies, Bringing Total Commercial Covered Lives to Over 110 Million

WESTLAKE VILLAGE, Calif., March 18, 2023 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc.  (Nasdaq: ARQT), an early commercial-stage company focused on developing meaningful innovations in immuno-dermatology, today presented in a late-breaking clinical trial session at the American Academy of Dermatology (AAD) annual meeting (New Orleans, LA, March 17-21) new data from its INTEGUMENT-1 and INTEGUMENT-2 pivotal Phase 3 studies of roflumilast cream 0.15% in adults and children 6 years and older with mild to moderate atopic dermatitis (AD). Roflumilast cream is a once-daily, steroid-free topical formulation of a highly potent and selective phosphodiesterase-4 (PDE4) inhibitor.

Arcutis Presents Late-Breaking Data from the INTEGUMENT Phase 3 Trials in Atopic Dermatitis at American Academy of Dermatology Annual Meeting

WESTLAKE VILLAGE, Calif., March 09, 2023 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc.  (Nasdaq: ARQT), an early commercial-stage company focused on developing meaningful innovations in immuno-dermatology, today announced six presentations at the 2023 American Academy of Dermatology (AAD) annual meeting, which will take place in New Orleans from March 17-21, 2023 and an additional poster at the SOCS Symposium on March 16, 2023. Among these will be the presentation of late-breaking clinical data on roflumilast cream 0.15% in patients aged 6 years and older with atopic dermatitis from the pivotal Phase 3 INTEGUMENT-1 and INTEGUMENT-2 Phase 3 trials.

Arcutis to Present New Topical Roflumilast Data Including Late Breaking Atopic Dermatitis Pivotal Trial Data During the American Academy of Dermatology (AAD) Annual Meeting

Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT ) Q4 2022 Earnings Conference Call February 28, 2023 4:30 PM ET Company Participants Eric McIntyre - Head of Investor Relations Frank Watanabe - President & Chief Executive Officer Patrick Burnett - Chief Medical Officer Ken Lock - Chief Commercial Officer Scott Burrows - Chief Financial Officer Conference Call Participants Vikram Purohit - Morgan Stanley Seamus Fernandez - Guggenheim Ken Cacciatore - Cowen Greg Fraser - Truist Louise Chen - Cantor Rohit Bhasin - Needham & Company Uy Ear - Mizuho Group Operator Ladies and gentlemen, thank you for standing by. And welcome to Arcutis Biotherapeutics, Inc. Fourth Quarter 2022 Earnings Conference Call.

Arcutis Biotherapeutics, Inc. (ARQT) Q4 2022 Earnings Call Transcript

WESTLAKE VILLAGE, Calif., Feb. 28, 2023 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today reported financial results for the quarter and year ended December 31, 2022, and provided a business update.

Arcutis Announces Fourth Quarter and Full Year 2022 Financial Results and Provides Business Update

WESTLAKE VILLAGE, Calif., Feb. 21, 2023 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early commercial-stage company focused on developing meaningful innovations in immuno-dermatology, today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for roflumilast foam 0.3% for the treatment of moderate to severe seborrheic dermatitis in adults and adolescents. Roflumilast foam 0.3% is an investigational once-daily topical foam formulation of a highly potent and selective phosphodiesterase type 4 (PDE4) inhibitor being developed to treat inflammatory dermatoses, particularly in hair-bearing areas of the body such as the scalp, face, and trunk.

Arcutis Submits Topical Roflumilast Foam 0.3% New Drug Application to the FDA for the Treatment of Seborrheic Dermatitis in Adults and Adolescents

The market has discounted momentum around Arcutis' Zoryve label. This looks overdone and investors appear to have overlooked the additional data points surrounding the segment.

Arcutis Biotherapeutics: Market Discounting Zoryve Momentum

WESTLAKE VILLAGE, Calif., Feb. 08, 2023 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc.  (Nasdaq: ARQT), an early commercial-stage company focused on developing meaningful innovations in immuno-dermatology, today announced that it will host a conference call and webcast at 4:30 p.m. ET on Tuesday, February 28, 2022 to report its fourth quarter and full year financial results, and provide a business update.

Arcutis to Report Fourth Quarter 2022 Financial Results and Participate in Upcoming Investor Conference

WESTLAKE VILLAGE, Calif., Jan. 14, 2023 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early commercial-stage company focused on developing meaningful innovations in immuno-dermatology, today announced new safety and efficacy durability data from its open label Phase 2 long-term safety study evaluating once-daily roflumilast cream (0.3%) in adults with chronic plaque psoriasis. Roflumilast cream 0.3% (ZORYVE®) is a once-daily steroid free topical phosphodiesterase-4 (PDE4) inhibitor approved by the US Food and Drug Administration in July 2022.

Arcutis Presents New Phase 2 Long-Term Data Showing Sustained Efficacy and Clearance for a Median of 10 Months with Roflumilast Cream in Adults with Chronic Plaque Psoriasis

WESTLAKE VILLAGE, Calif., Dec. 19, 2022 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced the submission of a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) for the expanded indication of ZORYVE (roflumilast) cream 0.3% for the treatment of plaque psoriasis in children ages 2 to 11. As with adults and adolescents, plaque psoriasis is the most common form of psoriasis in children 2 to 11 years of age, with very similar clinical features.

Arcutis Submits Supplemental New Drug Application for ZORYVE® (roflumilast) Cream 0.3% for Expanded Indication for the Treatment of Plaque Psoriasis in Children Down to 2 Years of Age

WESTLAKE VILLAGE, Calif., Dec. 12, 2022 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc.  (Nasdaq: ARQT), an early commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced positive topline results from its INTEGUMENT-2 pivotal Phase 3 trial of roflumilast cream 0.15%, a once-daily, non-steroidal topical phosphodiesterase-4 (PDE4) inhibitor, in adults and children 6 years and older with mild to moderate atopic dermatitis (AD). The study met its primary endpoint, with 28.9% of individuals treated with roflumilast cream 0.15% achieving 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, compared to 12.0% of individuals treated with vehicle (P

Arcutis Announces Positive Topline Results from Second Atopic Dermatitis Pivotal Phase 3 Trial of Roflumilast Cream in Adults and Children Aged 6 and Older

WESTLAKE VILLAGE, Calif., Dec. 05, 2022 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced the first subject has been enrolled in a Phase 1b study evaluating ARQ-255, a topical suspension of ivarmactinib, a potent and specific janus kinase 1 (JAK1) inhibitor, for the treatment of alopecia areata. ARQ-255 has been specifically formulated with Arcutis' proprietary 4D technology to deliver drug deep into the skin to the base of the hair follicle, the site of the inflammation that underlies alopecia areata.

Arcutis Enrolls First Patient in Phase 1b Alopecia Areata Study Evaluating ARQ-255

MySebDermTeam provides trusted connection, information, and support to accelerate diagnosis and treatment SAN FRANCISCO, Dec. 1, 2022 /PRNewswire/ -- MyHealthTeam , creator of the largest and fastest-growing social networks for people living with chronic health conditions, today launched MySebDermTeam , an online community for those living with seborrheic dermatitis to find the people, support, and medically-reviewed information they need to better manage their condition. Created by MyHealthTeam, with sponsorship by Arcutis Biotherapeutics, an early commercial-stage company focused on developing meaningful innovations in immuno-dermatology, MySebDermTeam empowers individuals with information that helps them more effectively work with doctors throughout their seborrheic dermatitis diagnosis and treatment journey.

MyHealthTeam and Arcutis Biotherapeutics Launch New Social Network for People Living with Seborrheic Dermatitis

WESTLAKE VILLAGE, Calif., Nov. 28, 2022 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early commercial-stage company focused on developing meaningful innovations in immuno-dermatology, today announced the publication of positive patient-reported outcome itch data from its Phase 2b study evaluating once-daily roflumilast cream (0.3% and 0.15%) in adults with chronic plaque psoriasis. The study, which was published online in the American Journal of Clinical Dermatology shows that those treated with roflumilast cream 0.3% experienced significantly greater improvements in WI-NRS as well as severity and bother of itch (as measured by PSD) by the earliest timepoint measured, Week 2, and itch-related sleep loss from Weeks 6 through 12, than those treated with vehicle. Roflumilast is a selective, highly potent phosphodiesterase-4 inhibitor (PDE4), with greater affinity for PDE4 and approximately 25- to >300-fold more potency than other FDA-approved PDE4 inhibitors.

Study Showing Significant Improvements in Itch and Itch-Related Sleep Loss with Roflumilast Cream in Adults with Plaque Psoriasis Published in American Journal of Clinical Dermatology

WESTLAKE VILLAGE, Calif., Nov. 21, 2022 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc.  (Nasdaq: ARQT), an early-stage commercial company focused on developing meaningful innovations in immuno-dermatology, today announced the Company's inaugural Environmental, Social, and Governance (ESG) report including a baseline of key performance metrics.

Arcutis Biotherapeutics Publishes First Environmental, Social, and Governance (ESG) Report

WESTLAKE VILLAGE, Calif., Nov. 17, 2022 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early-stage commercial company focused on developing meaningful innovations in immuno-dermatology, today announced that ZORYVE® (roflumilast) cream 0.3% for the treatment of plaque psoriasis in adults and adolescents is now on Express Scripts national formularies for commercial benefit plans, effective November 18. Express Scripts' commercial national formularies provide access to more than 26 million commercial lives in the United States.

Arcutis' ZORYVE® (Roflumilast) Cream 0.3% Added to Express Scripts, Inc.® National Formularies in the United States

Arcutis Biotherapeutics (ARQT) reports positive top-line data from a phase III study of its lead candidate, roflumilast cream 0.15%, for treating atopic dermatitis.

Arcutis (ARQT) Up on Top-Line Data From Atopic Dermatitis Study

CORRECTION: In a press release issued earlier today under the same headline, please note that the p-value for WI-NRS should have been P

CORRECTION -- Arcutis Announces Positive Topline Results from INTEGUMENT-1 Pivotal Phase 3 Trial of Roflumilast Cream in Atopic Dermatitis in Adults and Children Aged Six Years and Older

WESTLAKE VILLAGE, Calif., Nov. 15, 2022 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc.  (Nasdaq: ARQT), an early commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced positive topline results from its INTEGUMENT-1 pivotal Phase 3 trial of roflumilast cream 0.15%, a once-daily, non-steroidal topical phosphodiesterase-4 (PDE4) inhibitor, in adults and children six years and older with mild to moderate atopic dermatitis (AD). The study met its primary endpoint with 32.0% of individuals treated with roflumilast cream 0.15% achieving 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, compared to 15.2% of individuals treated with vehicle (P

Arcutis Announces Positive Topline Results from INTEGUMENT-1 Pivotal Phase 3 Trial of Roflumilast Cream in Atopic Dermatitis in Adults and Children Aged Six Years and Older

Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT ) Q3 2022 Earnings Conference Call November 8, 2022 5:00 PM ET Company Participants Eric McIntyre - Head, IR Todd Watanabe - President, CEO & Director Kenneth Lock - Chief Commercial Officer Patrick Burnett - SVP & Chief Medical Officer Scott Burrows - CFO & Principal Accounting Officer Conference Call Participants Kenneth Cacciatore - Cowen Vikram Purohit - Morgan Stanley Louise Chen - Cantor Fitzgerald Serge Belanger - Needham & Company Seamus Fernandez - Guggenheim Securities Gregory Fraser - Truist Securities Uy Ear - Mizuho Group Operator Good day, and thank you for standing by. Welcome to the Arcutis Biotherapeutics, Inc. Q3 2022 Earnings Conference Call.

Arcutis Biotherapeutics, Inc. (ARQT) Q3 2022 Earnings Call Transcript

Arcutis Biotherapeutics, Inc. (ARQT) delivered earnings and revenue surprises of -22.73% and 27.86%, respectively, for the quarter ended September 2022. Do the numbers hold clues to what lies ahead for the stock?

Arcutis Biotherapeutics, Inc. (ARQT) Reports Q3 Loss, Misses Revenue Estimates

WESTLAKE VILLAGE, Calif., Nov. 08, 2022 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today reported financial results for the quarter ended September 30, 2022, and provided a business update.

Arcutis Announces Third Quarter 2022 Financial Results and Provides Business Update

WESTLAKE VILLAGE, Calif., Oct. 25, 2022 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc.  (Nasdaq: ARQT), an early-stage commercial company focused on developing meaningful innovations in immuno-dermatology, today announced that it will host a conference call and webcast at 5:00 p.m. ET on Tuesday, November 8, 2022, to report its third quarter financial results.

Arcutis to Report Third Quarter Financial Results

WESTLAKE VILLAGE, Calif., Oct. 21, 2022 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc.  (Nasdaq: ARQT), an early-stage commercial company focused on developing meaningful innovations in immuno-dermatology, today announced results of a nationwide survey of adults with seborrheic dermatitis and the healthcare providers who treat them that highlights the long path to diagnosis and the general lack of awareness and education about the disease. The results were presented as a poster at the 2022 Fall Clinical Dermatology Conference in Las Vegas, Nevada. The online survey was conducted by The Harris Poll on behalf of Arcutis and included 300 U.S. adults (18+ years of age) who had been diagnosed with seborrheic dermatitis by a healthcare provider, of which 84% reported their current condition to be moderate or severe, and 601 licensed U.S. healthcare providers specializing in dermatology, including dermatologists, nurse practitioners (NPs), and physician assistants (PAs).

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