Articles from Arcutis Biotherapeutics, Inc.

WESTLAKE VILLAGE, Calif. and ORLANDO, Fla., March 07, 2025 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced new data from two posters shared at the 2025 American Academy of Dermatology Annual Meeting (AAD).

WESTLAKE VILLAGE, Calif., Feb. 28, 2025 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced that it will present two posters at the 2025 American Academy of Dermatology (AAD) annual meeting which will take place in Orlando, FL, from March 7 – 11, 2025.

WESTLAKE VILLAGE, Calif., Feb. 26, 2025 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced the FDA’s acceptance of a supplemental New Drug Application (sNDA) for ZORYVE (roflumilast) cream 0.05%, a once-daily, next generation phosphodiesterase-4 (PDE4) inhibitor, for the topical treatment of mild to moderate AD in children 2 to 5 years old. The FDA has set a PDUFA target action date of October 13, 2025 for this application. 

WESTLAKE VILLAGE, Calif., Feb. 25, 2025 (GLOBE NEWSWIRE) --

WESTLAKE VILLAGE, Calif., Feb. 24, 2025 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced that Pediatric Dermatology published online positive results from INTEGUMENT-PED, the pivotal phase 3 randomized vehicle-controlled trial evaluating the efficacy and safety of ZORYVE (roflumilast) cream 0.05% as a once-daily, steroid-free treatment for mild to moderate atopic dermatitis (AD) in children 2 to 5 years old.  

WESTLAKE VILLAGE, Calif., Jan. 12, 2025 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced certain preliminary unaudited financial information for the fourth quarter and full-year 2024.

WESTLAKE VILLAGE, Calif., Dec. 16, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a 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 ZORYVE (roflumilast) cream 0.05%, a once-daily, next generation phosphodiesterase 4 (PDE4) inhibitor, for the topical treatment of mild to moderate AD in children 2 to 5 years old.

WESTLAKE VILLAGE, Calif., Nov. 13, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced that Arcutis’ ZORYVE® (roflumilast) cream 0.15% has received Glamour’s 2024 Health and Wellness award for Best Eczema Product. The Best Beauty Innovators category acknowledges breakthrough innovations from the past year.

WESTLAKE VILLAGE, Calif., Nov. 06, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today reported financial results for the quarter ended September 30, 2024, and provided a business update.

WESTLAKE VILLAGE, Calif., Oct. 24, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced new patient-reported outcome data demonstrating that ZORYVE cream 0.15% improved the impact of AD on patients, families, and caregivers. These results, along with efficacy, safety, and tolerability data from Phase 3 INTEGUMENT-1 and -2, will be shared in an oral presentation at the ACAAI 2024 Annual Scientific Meeting held October 24-28, 2024, in Boston, MA.

WESTLAKE VILLAGE, Calif., Oct. 18, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced that its wholly-owned subsidiary Arcutis Canada, Inc. has received regulatory approval from Health Canada for ZORYVE (roflumilast) topical foam 0.3% for the treatment of seborrheic dermatitis in patients 9 years of age and older. The full Canadian product monograph for ZORYVE is available here.

WESTLAKE VILLAGE, Calif., Sept. 24, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology and immunology, today announced new pooled subgroup analysis results from the Phase 3 INTEGUMENT-1 and -2 trials showing that ZORYVE cream 0.15% provided consistent and meaningful improvements in signs and symptoms of AD in individuals regardless of race, ethnicity, and Fitzpatrick skin types. The results will be presented in a poster at the European Academy of Dermatology & Venereology Congress held September 25-28, 2024, in Amsterdam.

WESTLAKE VILLAGE, Calif., Sept. 24, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced the FDA has accepted its sNDA for ZORYVE (roflumilast) foam 0.3%, a once-daily, next generation phosphodiesterase-4 (PDE4) inhibitor, for the treatment of adults and adolescents ages 12 and over with scalp and body psoriasis. The FDA assigned the application a PDUFA target action date of May 22, 2025.

WESTLAKE VILLAGE, Calif., Sept. 19, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced that the Journal of American Medical Association Dermatology (JAMA Dermatology) published the positive results from two pivotal Phase 3 studies (INTEGUMENT-1 and INTEGUMENT-2) evaluating the efficacy and safety of ZORYVE® (roflumilast) cream 0.15% as a once-daily, steroid-free treatment for mild to moderate AD. ZORYVE cream, 0.15%, was approved in July 2024 by the U.S. Food and Drug Administration (FDA) for the topical treatment of mild to moderate AD in adult and pediatric patients 6 years of age and older and is available in pharmacies nationwide.

WESTLAKE VILLAGE, Calif., Sept. 05, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced the enrollment of the last subject in the Phase 1b study evaluating ARQ-255, a topical suspension of ivarmacitinib, a potent and selective 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.

WESTLAKE VILLAGE, Calif., Aug. 28, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (NASDAQ: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced results from the INTEGUMENT-OLE long-term open-label study of once-daily roflumilast cream 0.05% demonstrating the durable efficacy and favorable safety profile of roflumilast cream 0.05% in the treatment of mild to moderate AD in children 2 to 5 years old. In the study, roflumilast cream was well-tolerated, with no new safety signals observed during treatment of up to 56 weeks in duration. Efficacy was not only maintained but improved over time, with 71.9% of participants who rolled over from the roflumilast cream 0.05% treatment arm in INTEGUMENT-PED achieving 75% improvement from baseline in Eczema Area and Severity Index (EASI-75) after 56 weeks.

WESTLAKE VILLAGE, Calif., Aug. 14, 2024 (GLOBE NEWSWIRE) -- In a release issued under the same headline earlier today by Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), please note that in the section of Recent Corporate Highlights, in the third bullet point, the date for the extended maturity should be August 2029, not June 2029. The corrected release follows:

WESTLAKE VILLAGE, Calif., Aug. 14, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today reported financial results for the quarter ended June 30, 2024, and provided a business update.

WESTLAKE VILLAGE, Calif. and MONTGOMERY, Ala., July 29, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced the signing of a co-promotion agreement with Kowa Pharmaceuticals America, Inc., a company committed to the development and commercialization of safe and effective healthcare solutions. Under the agreement, Kowa will leverage its primary care sales force to market and promote ZORYVE (roflumilast) cream and ZORYVE (roflumilast) foam to primary care practitioners and pediatricians for all FDA approved indications. Arcutis will maintain responsibility for the marketing and sales of ZORYVE to dermatologists, other dermatology clinicians, and related specialists. This partnership is expected to expand the total addressable market for ZORYVE, providing access to a large portion of the 7.4 million patients treated outside of dermatology offices.

WESTLAKE VILLAGE, Calif., July 29, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced the commercial launch of ZORYVE® (roflumilast) cream 0.15% for the treatment of mild to moderate atopic dermatitis in adults and children down to age 6 in the United States. ZORYVE is a once-daily, steroid-free cream that provides rapid disease clearance and significant reduction in itch, and was developed to provide long-term disease control.

WESTLAKE VILLAGE, Calif., July 23, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced the submission of a supplemental New Drug Application (sNDA) for ZORYVE (roflumilast) foam 0.3%, a once-daily, next generation phosphodiesterase-4 (PDE4) inhibitor, for the treatment of adults and adolescents ages 12 and over with scalp and body psoriasis.

WESTLAKE VILLAGE, Calif., July 22, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced that it will host a virtual Key Opinion Leader (KOL) event featuring a leading dermatology and immune-mediated skin disease expert to discuss the unmet need and current treatment landscape for individuals with mild to moderate atopic dermatitis (AD). The event will highlight the differentiating features of and commercialization plans for ZORYVE® (roflumilast) cream 0.15%, which recently received FDA approval for the treatment of AD in adults and children down to age 6.

WESTLAKE VILLAGE, Calif., July 09, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for ZORYVE (roflumilast) cream, 0.15%, for the treatment of mild to moderate atopic dermatitis in adult and pediatric patients 6 years of age and older. ZORYVE is a once-daily, steroid-free cream that provides rapid disease clearance and significant reduction in itch and has been specifically developed to be a treatment option for long-term disease control.

WESTLAKE VILLAGE, Calif., July 09, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced that the Company has been in communication with the U.S. Food and Drug Administration (FDA) regarding its supplemental New Drug Application (sNDA) for roflumilast cream 0.15% for the treatment of mild to moderate atopic dermatitis (AD) for adults and children down to the age of 6. The FDA has indicated that they are working to finalize the action letter and have not indicated they would extend the Prescription Drug User Fee Act (PDUFA) goal date of July 7, 2024.

CHICAGO and WESTLAKE VILLAGE, Calif., June 10, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced new results from the INTEGUMENT-OLE long-term open-label study of investigational once-daily roflumilast cream 0.15% in adults and children ages 6 years and older with AD presented at the Revolutionizing Alopecia Areata, Vitiligo, and Eczema Conference. In the study, roflumilast cream was well-tolerated, with no new safety signals observed over 56 weeks of treatment. Efficacy was not only maintained but improved over time, with 56.6% of participants who continued use of roflumilast cream from the initial trial and 53.8% of participants who switched to roflumilast cream 0.15% from vehicle after the initial trial achieving validated Investigator Global Assessment-Atopic Dermatitis (vIGA-AD) success, defined as vIGA-AD value of 0 or 1 plus a 2-grade improvement from baseline, at Week 56.

WESTLAKE VILLAGE, Calif., June 05, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage company focused on developing meaningful innovations in immuno-dermatology, today announced that five abstracts will be presented at the Revolutionizing Alopecia Areata, Vitiligo, and Eczema Conference, which will take place in Chicago, IL from June 8-10, 2024. Among these presentations will be new long-term safety and efficacy data for roflumilast cream 0.15% in patients ≥6 years of age with mild to moderate atopic dermatitis, and an encore of preclinical data on ARQ-234, a CD200 receptor agonist the Company is investigating for atopic dermatitis.

WESTLAKE VILLAGE, Calif., May 14, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today reported financial results for the quarter ended March 31, 2024, and provided a business update.

WESTLAKE VILLAGE, Calif., May 13, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced that the Journal of Clinical and Aesthetic Dermatology (JCAD) published the outcomes of a comprehensive evaluation by an expert dermatologist panel assessing the formulation ingredients of ZORYVE (roflumilast) topical foam, 0.3%. ZORYVE foam is a once-daily steroid-free treatment for seborrheic dermatitis. The published article supports the use of ZORYVE foam in all hair and skin types.

WESTLAKE VILLAGE, Calif., April 29, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced that it will report first quarter 2024 financial results and provide a business update on Tuesday, May 14, 2024 after the U.S. financial markets close. The Company will also host a conference call and webcast the same day at 4:30 p.m. ET.

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WESTLAKE VILLAGE, Calif., March 11, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage company focused on developing meaningful innovations in immuno-dermatology, today announced the promotion of Todd Tucker to senior vice president and Chief Human Resources Officer (CHRO), effective immediately. Mr. Tucker joined Arcutis in July 2020 as executive director and head of human resources and was promoted to vice president of human resources in March 2022. Prior to joining Arcutis, he held leadership roles in human resources and employee management at multiple pharmaceutical companies including Atara Biotherapeutics, Sienna Biopharmaceuticals, and Kythera.

SAN DIEGO, March 10, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical 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 (San Diego, CA, March 8 – 12) new data from its INTEGUMENT-PED pivotal Phase 3 study of investigational roflumilast cream 0.05% in children 2 to 5 years of age with mild to moderate atopic dermatitis. The study found that treatment with once-daily, steroid-free roflumilast cream 0.05% resulted in significant improvements in atopic dermatitis across multiple efficacy endpoints and all timepoints, including disease clearance as early as Week 1 and reduction in itch in the first 24 hours following application.

SAN DIEGO, Calif., March 09, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, highlights new research that, for the first time, reveals the gene expression profile of seborrheic dermatitis. The Arcutis sponsored research from The Kimberly and Eric J. Waldman Department of Dermatology at the Icahn School of Medicine at Mount Sinai was presented in a scientific session at the American Academy of Dermatology (AAD) annual meeting (San Diego, CA, March 8 – 12) and answers key questions on the immune response and associated skin barrier disruption of seborrheic dermatitis.

WESTLAKE VILLAGE, Calif., March 04, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced the closing of its previously announced underwritten public offering of 18,157,895 shares of common stock at a public offering price of $9.50 per share, which includes 2,368,421 shares issued upon the exercise in full by the underwriters of their option to purchase additional shares of common stock at the public offering price, less underwriting discounts and commissions. The total gross proceeds of the public offering were approximately $172.5 million, before deducting underwriting discounts and commissions and offering expenses payable by Arcutis. All of the shares in the public offering were sold by Arcutis.

WESTLAKE VILLAGE, Calif., March 04, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced five presentations at the 2024 American Academy of Dermatology (AAD) annual meeting, which will take place in San Diego, CA from March 8 - 12, 2024. Among these presentations will be late-breaking clinical data on roflumilast cream 0.05% in patients 2 to 5 years of age with mild to moderate atopic dermatitis from the pivotal INTEGUMENT-PED Phase 3 randomized controlled trial.

WESTLAKE VILLAGE, Calif., Feb. 28, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced the pricing of its underwritten public offering of common stock. Arcutis is selling 15,789,474 shares of common stock in the offering. The shares of common stock are being sold at a public offering price of $9.50 per share. All shares of common stock to be sold in the offering are being offered by Arcutis. In addition, Arcutis has granted the underwriters a 30-day option to purchase up to an additional 2,368,421 shares of its common stock at the public offering price per share, less underwriting discounts and commissions. The gross proceeds to Arcutis from the offering are expected to be approximately $150.0 million, before deducting underwriting discounts and commissions and offering expenses payable by Arcutis and assuming no exercise of the underwriters’ option to purchase additional shares. Subject to the satisfaction of customary conditions, the offering is expected to close on March 4, 2024.

WESTLAKE VILLAGE, Calif., Feb. 28, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced the commencement of an underwritten public offering of $150.0 million of shares of its common stock and, in lieu of common stock to certain investors, pre-funded warrants to purchase shares of its common stock. All of the shares of common stock and pre-funded warrants in this offering are being sold by Arcutis. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. In addition, Arcutis intends to grant the underwriters a 30-day option to purchase up to an additional $22.5 million of shares of its common stock at the public offering price per share.

WESTLAKE VILLAGE, Calif. and TOKYO, Feb. 28, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, and Sato Pharmaceutical Co., Ltd., a leading pharmaceutical company, today announced that the companies have entered into a strategic collaboration and licensing agreement for the development, manufacture, and commercialization of topical roflumilast in Japan. Sato will receive an exclusive license for both the cream and foam formulations of topical roflumilast, a next generation phosphodiesterase type 4 (PDE4) inhibitor, for multiple dermatological conditions including plaque psoriasis, seborrheic dermatitis, atopic dermatitis, and potentially additional dermatological conditions in the future.

WESTLAKE VILLAGE, Calif., Feb. 27, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today reported financial results for the quarter and year ended December 31, 2023, and provided a business update.

WESTLAKE VILLAGE, Calif., Jan. 29, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced that the Journal of American Academy of Dermatology (JAAD) published positive results from the pivotal Phase 3 STRATUM trial evaluating ZORYVE (roflumilast) foam, 0.3% as a once-daily steroid-free treatment for seborrheic dermatitis. The article was published online, and found that treatment with ZORYVE foam was superior to vehicle, with 80% of individuals achieving the primary efficacy endpoint of Investigator Global Assessment (IGA) Success and 51% of individuals reaching complete clearance at Week 8. ZORYVE foam was approved by the U.S. Food and Drug Administration (FDA) for treatment of seborrheic dermatitis in adult and pediatric patients 9 years of age and older in December 2023 and is the first drug approved for seborrheic dermatitis with a new mechanism of action in over two decades.

WESTLAKE VILLAGE, Calif., Jan. 22, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced the launch of ZORYVE® (roflumilast) topical foam, 0.3%, in the United States for the treatment of seborrheic dermatitis in individuals 9 years of age and older. ZORYVE is a once-daily steroid-free foam and is the first drug approved for seborrheic dermatitis with a new mechanism of action in over two decades.

WESTLAKE VILLAGE, Calif., Jan. 14, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced a new subgroup analysis highlighting that adults and adolescents with seborrheic dermatitis who are contraindicated, intolerant, or unresponsive to topical steroids were 3.5 times more likely to achieve IGA Success with ZORYVE® (roflumilast) topical foam, 0.3%, compared to vehicle (78.8% ZORYVE foam; 48.3% vehicle; p<0.001)i. ZORYVE foam is a once-daily steroid-free topical for use in all skin and hair types that effectively clears and controls seborrheic dermatitis. Data were presented at the 2024 Winter Clinical Dermatology Conference – Hawaii held January 12-17, 2024, in Honolulu.

WESTLAKE VILLAGE, Calif., Jan. 14, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced new individual patient response data showing the vast majority of individuals (91.5%) treated with investigational roflumilast cream 0.15% had a measurable improvement in Eczema Area and Severity Index (EASI) in 4 weeks. New pooled analyses from two pivotal Phase 3 studies (INTEGUMENT-1 and INTEGUMENT-2) were presented at the 2024 Winter Clinical Dermatology Conference – Hawaii held January 12-17, 2024, in Honolulu, HI. Roflumilast cream 0.15% is a once-daily, steroid-free cream being investigated for adults and children 6 years of age and older with atopic dermatitis.

WESTLAKE VILLAGE, Calif., Dec. 15, 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 approved the new drug application (NDA) for ZORYVE (roflumilast) topical foam, 0.3% for the treatment of seborrheic dermatitis in individuals 9 years of age and older. ZORYVE foam provides rapid disease clearance and significant reduction in itch, with nearly 80% of individuals achieving the primary efficacy endpoint of IGA Success and just over 50% of individuals reaching complete clearance at Week 8 in the STRATUM trial. ZORYVE is a once-daily steroid-free foam and the first drug approved for seborrheic dermatitis with a new mechanism of action in over two decades.

WESTLAKE VILLAGE, Calif., Nov. 29, 2023 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced the U.S. Food and Drug Administration (FDA) has accepted its supplemental new drug application (sNDA) for roflumilast cream 0.15% for the treatment of atopic dermatitis (AD) in adults and children down to age 6. Roflumilast cream is a once-daily, steroid-free, phosphodiesterase-4 (PDE4) inhibitor. The FDA assigned the application a Prescription Drug User Fee Act (PDUFA) target action date of July 07, 2024.

WESTLAKE VILLAGE, Calif., Nov. 03, 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 ended September 30, 2023, and provided a business update.

WESTLAKE VILLAGE, Calif., Oct. 25, 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 8:30 a.m. ET on Friday, November 3, 2023 to report its third quarter financial results and provide a business update.

WESTLAKE VILLAGE, Calif., Oct. 20, 2023 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced new individual patient response data showing nearly all individuals (95%) treated with ZORYVE® (roflumilast) cream 0.3% had a measurable improvement in Psoriasis Area and Severity Index (PASI). Separately reported investigator and patient local tolerability assessment data confirms again that ZORYVE was well tolerated from first application. New analyses from two pivotal Phase 3 studies (DERMIS-1 and DERMIS-2) were presented in two posters at the 43rd Annual Fall Clinical Dermatology Conference held October 19-22, 2023, in Las Vegas, Nevada. ZORYVE is a once-daily, steroid-free cream for individuals with plaque psoriasis down to 6 years of age that can be used for any duration across all affected areas of the body.

WESTLAKE VILLAGE, Calif., Oct. 19, 2023 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) (“Arcutis”), an early commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced the pricing of its underwritten public offering of common stock and, in lieu of common stock to certain investors, pre-funded warrants. Arcutis is selling 32,500,000 shares of common stock and, in lieu of common stock to certain investors, pre-funded warrants to purchase 7,500,000 shares of common stock in the offering. The shares of common stock are being sold at a public offering price of $2.50 per share and the pre-funded warrants are being sold at a public offering price of $2.4999 per pre-funded warrant, which represents the per share public offering price for each share of common stock less the $0.0001 per share exercise price for each pre-funded warrant. All shares of common stock and pre-funded warrants to be sold in the offering are being offered by Arcutis. In addition, Arcutis has granted the underwriters a 30-day option to purchase up to an additional 6,000,000 shares of its common stock at the public offering price per share, less underwriting discounts and commissions. The gross proceeds to Arcutis from the offering are expected to be approximately $100.0 million, before deducting underwriting discounts and commissions and estimated offering expenses payable by Arcutis, excluding the exercise of any pre-funded warrants and assuming no exercise of the underwriters’ option to purchase additional shares. Subject to the satisfaction of customary conditions, the offering is expected to close on October 24, 2023.

WESTLAKE VILLAGE, Calif., Oct. 19, 2023 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) (“Arcutis”), an early commercial-stage company focused on developing meaningful innovations in immuno-dermatology, today announced the commencement of an underwritten public offering of $100.0 million of shares of its common stock and, in lieu of common stock to certain investors, pre-funded warrants to purchase shares of its common stock. All of the shares of common stock and pre-funded warrants in this offering are being sold by Arcutis. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. In addition, Arcutis intends to grant the underwriters a 30-day option to purchase up to an additional $15.0 million of shares of its common stock at the public offering price per share.

WESTLAKE VILLAGE, Calif., Oct. 13, 2023 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced new data from its pivotal ARRECTOR Phase 3 trial of roflumilast foam 0.3% for the treatment of adults and adolescents with scalp and body psoriasis. 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. The results, including new patient-reported outcome data, were presented at the EADV Congress held October 11-14, 2023, in Berlin.

Expanded indication for ZORYVE provides new, steroid-free topical for children 6 to 11 with plaque psoriasis, including intertriginous psoriasis

WESTLAKE VILLAGE, Calif., Sept. 27, 2023 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced the appointment of Todd Edwards as Chief Commercial Officer (CCO), effective immediately. Mr. Edwards brings to Arcutis over 25 years of sales, market access, marketing, and general management experience from leading companies in dermatology and immunology, including Incyte, UCB, and AbbVie.

WESTLAKE VILLAGE, Calif., Sept. 25, 2023 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (NASDAQ: ARQT), an early commercial-stage company focused on developing meaningful innovations in immuno-dermatology, today announced the launch of an educational campaign designed to elevate understanding, connection, and encouragement for those living with seborrheic dermatitis, or Seb Derm for short. The campaign, Clearing Up Seb Derm, features expert advice from leading dermatologists and personal stories from individuals living with seborrheic dermatitis.

WESTLAKE VILLAGE, Calif., Sept. 19, 2023 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (NASDAQ: ARQT), an early commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced that the INTEGUMENT-PED pivotal Phase 3 trial of roflumilast cream 0.05%, in children ages 2 to 5 years with mild to moderate atopic dermatitis (AD) met its primary endpoint and all secondary endpoints. In the study, 25.4% of children treated with roflumilast cream 0.05% achieved 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 10.7% treated with vehicle (P<0.0001), with significant improvements seen as early as Week 1.Roflumilast cream 0.05% is a once-daily steroid-free topical cream in development, that is formulated to deliver drug without disrupting the skin barrier. INTEGUMENT-PED enrolled 652 children ages 2 to 5, with a mean Body Surface Area (BSA) of 22% overall, and a range from 3% to 82%. The data reinforce the well-established efficacy, safety and tolerability profile of roflumilast cream in atopic dermatitis across the INTEGUMENT program.

WESTLAKE VILLAGE, Calif., Sept. 12, 2023 (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 roflumilast cream 0.15% for the treatment of mild to moderate atopic dermatitis (AD) in adults and children ages 6 years and older.

WESTLAKE VILLAGE, Calif., Sept. 07, 2023 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (NASDAQ: ARQT), an early commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced interim results from the INTEGUMENT-OLE long-term open-label study of roflumilast cream 0.15% in adults and children ages 6 years and older with atopic dermatitis. In the study, roflumilast cream was well-tolerated, with no new safety signals observed during treatment up to 56 weeks in duration. Efficacy was not only maintained but improved over time, with 46.1% and 51.0% of participants who rolled over from the roflumilast cream treatment arm in INTEGUMENT-1 or -2 achieving validated Investigator Global Assessment-Atopic Dermatitis (vIGA-AD) success, defined as vIGA-AD value of 0 or 1 plus a 2-grade improvement from baseline, at Weeks 28 and 56, respectively.

WESTLAKE VILLAGE, Calif., Sept. 05, 2023 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early-stage commercial company focused on developing meaningful innovations in immuno-dermatology, today announced that Arcutis management will participate in an upcoming investor conference.

WESTLAKE VILLAGE, Calif., Aug. 31, 2023 (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 its annual Environmental, Social, and Governance (ESG) report. The second annual report details the Company’s advancement toward improving patient care, access and affordability, social capital management, drug safety, sustainable operations, and ethical business practices.

WESTLAKE VILLAGE, Calif., Aug. 29, 2023 (GLOBE NEWSWIRE) --  Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced the launch of The Cream That Can, the first commercial direct-to-consumer ad for ZORYVE® (roflumilast) cream 0.3% for the treatment of plaque psoriasis, including intertriginous psoriasis in adults and adolescents. The Cream That Can campaign invites individuals with psoriasis to reimagine a steroid-free cream for their psoriasis.

Former and First Arcutis CFO, John Smither, Appointed Interim

WESTLAKE VILLAGE, Calif. and HANGZHOU, China, Aug. 10, 2023 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, and Hangzhou Zhongmei Huadong Pharmaceutical Co, a wholly owned subsidiary of Huadong Medicine Co., Ltd. (SZ.000963), today announced that the companies have entered into a strategic collaboration and licensing agreement for the development, manufacture, and commercialization of topical roflumilast in Greater China (mainland China, Hong Kong, Macau, and Taiwan) and Southeast Asia (Indonesia, Singapore, The Philippines, Thailand, Myanmar, Brunei, Cambodia, Laos, Malaysia, and Vietnam). Huadong will receive an exclusive license for both the cream and foam formulations of topical roflumilast, a next generation phosphodiesterase type 4 (PDE4) inhibitor, for multiple dermatological conditions including plaque psoriasis, seborrheic dermatitis, and atopic dermatitis, and potentially additional dermatological conditions in the future.

WESTLAKE VILLAGE, Calif., Aug. 08, 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 ended June 30, 2023, and provided a business update.

WESTLAKE VILLAGE, Calif., July 24, 2023 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early commercial-stage biopharmaceutical 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, August 8, 2023, to report its second quarter financial results.

WESTLAKE VILLAGE, Calif., July 17, 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 now covered as a preferred tier product on CVS Caremark’s largest national commercial formularies effective July 5. These national formularies provide access to an additional 20 million commercial lives in the United States.

WESTLAKE VILLAGE, Calif., June 06, 2023 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early-stage commercial company focused on developing meaningful innovations in immuno-dermatology, today announced that Arcutis management will participate in an upcoming investor conference.

WESTLAKE VILLAGE, Calif., May 09, 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 ended March 31, 2023, and provided a business update.

WESTLAKE VILLAGE, Calif., May 02, 2023 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early commercial-stage biopharmaceutical company focused on developing meaningful innovations in immune-dermatology, today announced the enrollment of the last subject in the INTEGUMENT-PED Pivotal Phase 3 trial evaluating roflumilast cream 0.05% for the treatment of mild to moderate AD in children ages 2 to 5. Roflumilast cream is a once-daily topical formulation of roflumilast, a highly potent and selective phosphodiesterase type 4 inhibitor (PDE4), which the Company is evaluating in two doses for AD: 0.15% for adults and children 6 years of age and older, and 0.05% for children aged 2 to 5 years. Arcutis previously reported positive topline data in similarly designed Pivotal Phase 3 trials of roflumilast cream 0.15% in ages 6 and above.

WESTLAKE VILLAGE, Calif., April 28, 2023 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, announced today that its next-generation topical PDE4 inhibitor therapy for plaque psoriasis, ZORYVE™ (roflumilast) cream 0.3%, has received regulatory approval from Health Canada.

WESTLAKE VILLAGE, Calif., April 25, 2023 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early commercial-stage biopharmaceutical 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, May 9, 2023, to report its first quarter financial results.

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.

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.

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.

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.

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.