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., June 06, 2022 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc.  (Nasdaq: ARQT), a late-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced positive topline results from the STRATUM pivotal Phase 3 trial investigating roflumilast foam as a potential treatment for adolescents and adults with moderate to severe seborrheic dermatitis. Roflumilast foam 0.3%, 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, demonstrated significant improvements based on IGA Success and other endpoints.

Arcutis Announces Positive Topline Results from STRATUM Pivotal Phase 3 Trial of Roflumilast Foam 0.3% in Seborrheic Dermatitis

WESTLAKE VILLAGE, Calif., May 25, 2022 (GLOBE NEWSWIRE) -- In a release issued under the same headline on Wednesday, May 25th by Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), please note that seborrehic in the headline is seborrheic.

CORRECTION: Nationwide Survey of People with Seborrheic Dermatitis Reveals Dissatisfaction with Current Treatment Options and Burden of Daily Care

WESTLAKE VILLAGE, Calif., May 25, 2022 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc.  (Nasdaq: ARQT), a late-stage biopharmaceutical 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 that treat them, designed to better understand their satisfaction and experience with currently available treatment options. The online survey was conducted by The Harris Poll on behalf of Arcutis and included 300 U.S. adults (18+ years) who have been diagnosed with seborrheic dermatitis, of which 84% reported their condition to be moderate or severe, and 601 licensed U.S. healthcare providers, including dermatologists, nurse practitioners (NPs), and physician assistants (PAs).

Nationwide Survey of People with Seborrehic Dermatitis Reveals Dissatisfaction with Current Treatment Options and Burden of Daily Care

WESTLAKE VILLAGE, Calif., May 05, 2022 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a late-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today reported financial results for the quarter ended March 31, 2022, and provided a business update.

Arcutis Announces First Quarter 2022 Financial Results and Provides Business Update

WESTLAKE VILLAGE, Calif., April 06, 2022 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc.  (Nasdaq: ARQT), a late-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced the enrollment of the last subject in its ARRECTOR pivotal Phase 3 trial of topical roflumilast foam in adolescents and adults with scalp and body psoriasis. Roflumilast foam is a once-daily, topical formulation of a highly potent and selective phosphodiesterase-4 (PDE4) inhibitor (roflumilast). The foam formulation was designed to treat all areas of the body, including the face and particularly hair-bearing areas such as the scalp. If successful, the Company believes that this trial will provide sufficient basis to file a supplemental New Drug Application (sNDA) in the U.S. for roflumilast foam in scalp and body psoriasis.

Arcutis Completes Enrollment in ARRECTOR Pivotal Phase 3 Trial of Topical Roflumilast Foam in Scalp and Body Psoriasis

Phase 3 data from the DERMIS Phase 3 trials demonstrated an excellent efficacy profile for roflumilast in psoriasis.

Arcutis: Roflumilast Has Excellent Data And High Probability Of FDA Approval

WESTLAKE VILLAGE, Calif., March 28, 2022 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc.  (Nasdaq: ARQT), a late-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, outlines the company's growth strategy and continued clinical progress of its broad immuno-dermatology pipeline during today's Investor Day in Boston, MA at 10:30 a.m. EST.

Arcutis Highlights Growth Opportunities at Investor Day in Advance of 2022 Catalysts

WESTLAKE VILLAGE, Calif., March 25, 2022 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc.  (Nasdaq: ARQT), a late-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced the presentation of results from the Phase 2 study of its investigational roflumilast foam 0.3%, a novel, once-daily non-steroidal foam for the treatment of seborrheic dermatitis, at the 2022 American Academy of Dermatology annual meeting, taking place in Boston, MA. Previously reported safety and efficacy data was recapitulated along with new patient quality of life data that showed significant improvement in all emotional, symptom, and function measures. Seborrheic dermatitis is a chronic inflammatory skin condition that impacts 10 million people in the United States.

Arcutis' Roflumilast Foam Demonstrates Clinically Meaningful Results and Patient Quality of Life Improvements in Phase 2 Seborrheic Dermatitis Study

WESTLAKE VILLAGE, Calif., March 25, 2022 (GLOBE NEWSWIRE) --   Arcutis Biotherapeutics, Inc.  (Nasdaq: ARQT), a late-stage biopharmaceutical company focused on developing meaningful innovations in immunodermatology, today announced new pooled results from the DERMIS Phase 3 trials of roflumilast cream are available in four abstracts at the 2022 American Academy of Dermatology annual meeting, taking place in Boston, MA. Roflumilast is a selective and highly potent phosphodiesterase-4 inhibitor (PDE4) being investigated by Arcutis as a non-steroidal topical treatment for multiple inflammatory skin diseases, including plaque psoriasis.

Arcutis Presents New Data on Once-Daily Roflumilast Cream for Plaque Psoriasis from DERMIS Phase 3 Trials at American Academy of Dermatology Annual Meeting

WESTLAKE VILLAGE, Calif., March 22, 2022 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc.  (Nasdaq: ARQT), a late-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced findings from the Skin Insights: Uncovering Psoriasis Survey, a national survey of 507 adults 18+ diagnosed with plaque psoriasis who are on topical treatments. The online survey was conducted by The Harris Poll and was designed to reveal insights into the emotional impact of the disease and challenges related to currently available topical treatments.

National Survey Reveals Insights into Emotional Impact of Psoriasis and Illuminates Need for New Topical Treatments

WESTLAKE VILLAGE, Calif., March 21, 2022 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc.  (Nasdaq: ARQT), a late-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, will host an Investor Day in Boston, MA on Monday, March 28, 2022 at 10:30 a.m. EDT. Frank Watanabe, President and Chief Executive Officer; Patrick Burnett, MD, PhD, FAAD, Chief Medical Officer; and Ken Lock, Chief Commercial Officer will present a comprehensive overview of the Company's strategy, launch preparations for investigational roflumilast cream in plaque psoriasis, the compelling profile of roflumilast cream in atopic dermatitis, the significant opportunity for roflumilast foam in in seborrheic dermatitis, and an update on the early pipeline development.

Arcutis to Host Investor Day on March 28

WESTLAKE VILLAGE, Calif., Feb. 22, 2022 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a late-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today reported financial results for the quarter and year ended December 31, 2021, and provided a business update.

Arcutis Announces Fourth Quarter and Full Year 2021 Financial Results and Provides Business Update

WESTLAKE VILLAGE, Calif., Feb. 01, 2022 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc.  (Nasdaq: ARQT), a late-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced the enrollment of the last subject in its STRATUM phase 3 pivotal trial for topical roflumilast foam in patients with seborrheic dermatitis. If positive, the Company expects the study to be sufficient basis to submit a New Drug Application (NDA) in the United States in first half of 2023.

Arcutis Completes Enrollment of STRATUM Pivotal Phase 3 Trial of Topical Roflumilast Foam in Individuals with Seborrheic Dermatitis

Arcutis Biotherapeutics Inc (NASDAQ: ARQT) has obtained a $225 million term loan facility from SLR Capital Partners (SLR).  This additional capital further strengthens Arcutis' balance sheet before a potential 2022 FDA approval & launch of topical roflumilast cream in plaque psoriasis and three 2022 pivotal data readouts in skin disorder trials.

Arcutis Secures $225M Debt Financing To Fund Potential Launch Of Roflumilast

WESTLAKE VILLAGE, Calif., Dec. 23, 2021 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc.  (Nasdaq: ARQT), a late-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced that it has obtained a $225 million term loan facility from funds managed by SLR Capital Partners (“SLR”). This additional capital further strengthens Arcutis' balance sheet in advance of a potential 2022 Food and Drug Administration (FDA) approval and launch of topical roflumilast cream in plaque psoriasis, and in advance of three 2022 pivotal clinical data readouts in atopic dermatitis, seborrheic dermatitis, and scalp psoriasis. This non-dilutive financing commitment extends the Company's cash runway into 2024.

Arcutis Biotherapeutics Secures $225 Million in Non-Dilutive Debt Financing from SLR Capital Partners

WESTLAKE VILLAGE, Calif., Dec. 22, 2021 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc.  (Nasdaq: ARQT), a late-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced the U.S. Food and Drug Administration's (FDA) acceptance for review of the company's new drug application (NDA) for roflumilast cream for the treatment of psoriasis in adults and adolescents. The FDA assigned the application a Prescription Drug User Fee Act (PDUFA) target action date of July 29, 2022.

FDA Accepts Arcutis Biotherapeutics' New Drug Application for Roflumilast Cream for Adults and Adolescents with Plaque Psoriasis

WESTLAKE VILLAGE, Calif., Dec. 16, 2021 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc.  (Nasdaq: ARQT), a late-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced the appointment of Mas Matsuda, Esq. as General Counsel and Corporate Secretary. Mr. Matsuda joins Arcutis from Halozyme Therapeutics Inc. and succeeds Keith Klein, Esq. who announced his retirement after a successful 30-year industry career. In this role, Mr. Matsuda will oversee all legal and compliance matters for the Company.

Arcutis Appoints Mas Matsuda as General Counsel and Corporate Secretary

WESTLAKE VILLAGE, Calif., Dec. 13, 2021 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc.  (Nasdaq: ARQT), a late-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced data suggesting that Arcutis' proprietary cream vehicle had similar moisturizing properties as a commercially marketed, dermatologist-recommended, ceramide-containing moisturizer in adults with mild eczema. The data from the two groups were similar across patient and healthcare provider assessments of tolerability and aesthetic improvement.

Arcutis Announces Data Comparing the Vehicle in Investigational Roflumilast Cream Against a Commercial Ceramide-Containing Moisturizing Cream

WESTLAKE VILLAGE, Calif., Nov. 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 reported financial results for the quarter ended September 30, 2021, and provided a business update.

Arcutis Announces Third Quarter 2021 Financial Results and Provides Business Update

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).

New Data Highlighting Itch Reduction with Topical Roflumilast in Multiple Dermatologic Conditions Presented at European Academy of Dermatology and Venereology Congress

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 Expands Patent Portfolio with Roflumilast Pharmacokinetics Patent

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.

New Topical Roflumilast Data Presented at the European Academy of Dermatology and Venereology (EADV) Congress

Management has high hopes for the company's treatment candidates for dermatological conditions, but can they get one to market before its cash cushion is depleted?

Is Now the Time to Bet on Arcutis Biotherapeutics?

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.

Arcutis to Present at Upcoming Investor Conferences

WESTLAKE VILLAGE, Calif., Sept. 02, 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 that Keith R. Leonard Jr. has been appointed to the Arcutis Board of Directors effective September 2, 2021, replacing Ricky Sun, Ph.D., who has decided to step down from the Board for personal reasons.

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