ZORYVE cream 0.15% is the first once-daily, Food and Drug Administration (FDA)-approved topical treatment for mild to moderate atopic dermatitis ZORYVE, a next-generation topical phosphodiesterase-4 (PDE4) inhibitor, recognized for redefining topical treatment drug delivery for immune-mediated skin diseases and for its proprietary formulation WESTLAKE VILLAGE, Calif., Nov. 13, 2024 (GLOBE NEWSWIRE) -- Arcutis... Read More

Third quarter net product revenues for ZORYVE® (roflumilast) franchise of $44.8M, with $22.0M for ZORYVE cream 0.3%, $20.3M for ZORYVE topical foam 0.3%, and $2.5M for ZORYVE cream 0.15%; sales growth of 452% vs. Q3 '23 and 45% vs. Q2 '24 Continued gross-to-net (GTN) improvement with blended GTN across products now in the low 50 percent range, improving from the high 50 percent range last quarter Sustained growth in... Read More

WESTLAKE VILLAGE, Calif., Nov. 04, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today reported the grant of an aggregate of 50,000 restricted stock units of Arcutis’ common stock as well as options to purchase an aggregate of 50,000 shares of Arcutis’ common stock to five newly hired... Read More

New patient-reported outcome data from INTEGUMENT-1 and -2 demonstrate that ZORYVE cream 0.15% rapidly decreased the impact of atopic dermatitis (AD), including sleep loss and daily activities, on patients and families ZORYVE cream 0.15% resulted in significant improvements across all efficacy endpoints, including validated Investigator Global Assessment-Atopic Dermatitis (vIGA-AD) Success and rapid itch reduction within... Read More

Quarterly investor conference call and webcast is scheduled for Wednesday, November 6 at 4:30 p.m. ET Arcutis management will also participate in the Guggenheim Securities Healthcare Innovation Conference in November WESTLAKE VILLAGE, Calif., Oct. 23, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in... Read More

Once-daily, steroid-free foam designed to treat seborrheic dermatitis on all affected areas of the body, including hair-bearing regions such as the scalp Clinical trial data show notable improvement in signs and symptoms, with the majority of patients experiencing reduced itching, scaling and redness, common burdens associated with seborrheic dermatitis 1 ZORYVE foam represents the first topical treatment for seborrheic... Read More

ZORYVE foam represents the first topical treatment for seborrheic dermatitis with a new mechanism of action approved in Canada in over two decades 1 Second approval of ZORYVE outside of the United States, expanding ZORYVE portfolio availability to over 2 million Canadians living with seborrheic dermatitis WESTLAKE VILLAGE, Calif., Oct. 18, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a... Read More

WESTLAKE VILLAGE, Calif., Oct. 04, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today reported the grant of an aggregate of 95,000 restricted stock units of Arcutis’ common stock as well as options to purchase an aggregate of 38,000 shares of Arcutis’ common stock to 11 newly hired... Read More

ZORYVE demonstrated consistent efficacy in disease clearance and reduction in itch for individuals with atopic dermatitis (AD) regardless of race, ethnicity, and Fitzpatrick skin type ZORYVE was safe and well tolerated across all subgroups Data presented at the 2024 European Academy of Dermatology & Venereology Congress WESTLAKE VILLAGE, Calif., Sept. 24, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT),... Read More

U.S. Food and Drug Administration (FDA) has set a Prescription Drug User Fee Act (PDUFA) target action date of May 22, 2025 Almost half of the 9 million individuals in the United States with plaque psoriasis experience involvement of the scalp Supplemental New Drug Application (sNDA) supported by positive efficacy and safety data from Phase 2b and pivotal Phase 3 trials, and long-term ZORYVE cream plaque psoriasis program... Read More

ZORYVE ® (roflumilast) cream 0.15% improved atopic dermatitis (AD) across multiple efficacy endpoints while demonstrating favorable safety and tolerability Across both studies, approximately 31% of children and adults treated with ZORYVE cream achieved the primary efficacy endpoint of Investigator Global Assessment (IGA) Success at Week 4 compared to 14% for vehicle, with significant improvement as early as Week 1 ZORYVE... Read More

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 reported the grant of an aggregate of 37,000 restricted stock units of Arcutis’ common stock to three newly hired employees. These awards were approved by the Compensation Committee of Arcutis’ Board of... Read More

ARQ-255 is a topical Janus kinase 1 (JAK1) inhibitor suspension formulated as a potential topical treatment for alopecia areata Proprietary Deep Dermal Drug Delivery (4D) technology formulated to deliver drug deep into the skin to the base of the hair follicle where alopecia areata inflammation occurs Phase 1b results expected first half of 2025 WESTLAKE VILLAGE, Calif., Sept. 05, 2024 (GLOBE NEWSWIRE) -- Arcutis... Read More

Long-term safety and tolerability profile consistent with pivotal data in atopic dermatitis (AD), with no new safety signals observed during 56 weeks of treatment Results from open-label extension study highlight that 71.9% of patients who rolled over from the roflumilast cream treatment arm in INTEGUMENT-PED achieved EASI-75 at Week 56 Arcutis intends to submit a supplemental New Drug Application (sNDA) to the U.S. Food and... Read More

WESTLAKE VILLAGE, Calif., Aug. 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 Arcutis management will participate in the Morgan Stanley 22 nd Annual Global Healthcare Conference. Details for the company’s participation are as follows: Fireside Chat Date: Thursday,... Read More

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: Second quarter net product revenues for ZORYVE ® franchise of... Read More

Second quarter net product revenues for ZORYVE ® franchise of $30.9M, with $17.3M for ZORYVE (roflumilast) cream 0.3%, and $13.6M for ZORYVE (roflumilast) topical foam, 0.3%; sales growth of 547% vs. Q2 '23 and 43% vs. Q1 '24 Continued gross-to-net (GTN) improvement with blended GTN across products now in the high 50 percent range, improving from the low 60 percent range last quarter Sustained growth in prescriptions for... Read More

WESTLAKE VILLAGE, Calif., Aug. 02, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today reported the grant of an aggregate of 38,000 restricted stock units of Arcutis’ common stock to four newly hired employees. These awards were approved by the Compensation Committee of Arcutis’ Board of... Read More

WESTLAKE VILLAGE, Calif., Aug. 01, 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 second quarter 2024 financial results and provide a business update on Wednesday, August 14, 2024 after the U.S. financial markets close. The Company will also host a... Read More

Over 200-person sales force to promote ZORYVE (roflumilast) in primary care and pediatric practices Provides access to a large portion of the 7.4 million individuals treated for plaque psoriasis, seborrheic dermatitis, and atopic dermatitis outside of dermatology offices ZORYVE will be promoted in the primary position to maximize prescriber education WESTLAKE VILLAGE, Calif. and MONTGOMERY, Ala., July 29, 2024 (GLOBE... Read More

Once-daily, effective, safe, and well-tolerated ZORYVE cream now commercially available Provides rapid clearance of atopic dermatitis signs and symptoms and significant reduction in itch, and can be used anywhere on the body for any duration to maintain clear skin Atopic dermatitis is the most common type of eczema, affecting approximately 9.6 million children and 16.5 million adults in the United States Management will host... Read More

Approximately 40% of the 9 million individuals in the United States with plaque psoriasis experience involvement of the scalp Once-daily ZORYVE foam significantly improved both scalp and body psoriasis in a Phase 2b and a pivotal Phase 3 trial Data also show rapid reduction in scalp itch as soon as 24 hours after first application ZORYVE foam demonstrated a favorable safety and tolerability profile WESTLAKE VILLAGE, Calif.,... Read More

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... Read More

ZORYVE cream provides rapid relief, with efficacy, safety, and tolerability demonstrated up to 56 weeks of treatment ZORYVE cream rapidly and significantly reduces itch, the most bothersome symptom of atopic dermatitis (AD) Once-daily cream is for use anywhere on the body for any duration AD is the most common type of eczema, affecting approximately 9.6 million children and 16.5 million adults in the United States Third FDA... Read More

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... Read More

WESTLAKE VILLAGE, Calif., July 03, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today reported the grant of an aggregate of 325,000 restricted stock units of Arcutis’ common stock as well as options to purchase an aggregate of 55,000 shares of Arcutis’ common stock to 43 newly hired... Read More

Investigational roflumilast cream 0.15% showed continued improvements in the signs and symptoms of AD, including itch, through 56 weeks of treatment 66.2% of participants treated with once-daily roflumilast cream 0.15% in both the 4-week parent study and the 52-week open label extension achieved a 75% improvement in Eczema Area and Severity Index (EASI-75) at Week 56 For participants who achieved disease clearance and... Read More

WESTLAKE VILLAGE, Calif., June 05, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today reported the grant of an aggregate of 57,500 restricted stock units of Arcutis’ common stock to six newly hired employees. These awards were approved by the Compensation Committee of Arcutis’ Board of... Read More

New long-term safety and efficacy data of investigational roflumilast cream 0.15% in mild to moderate atopic dermatitis will be presented in an oral session Preclinical data on ARQ-234, CD200R agonist, for the treatment of atopic dermatitis Additional presentation of the consistent tolerability profile of topical roflumilast in psoriasis, seborrheic dermatitis, and atopic dermatitis WESTLAKE VILLAGE, Calif., June 05, 2024... Read More

WESTLAKE VILLAGE, Calif., June 03, 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 management will participate in the Goldman Sachs 45th Annual Global Healthcare Conference, taking place June 10-13, 2024. Details for the company’s participation are as follows:... Read More

First quarter net product revenues for ZORYVE® franchise of $21.6M, with $15M for ZORYVE (roflumilast) cream 0.3%, and $6.5M for ZORYVE (roflumilast) topical foam, 0.3%; sales growth of 675% vs. Q1 '23 and 59% vs. Q4 '23 Continued gross-to-net (GTN) improvement with blended GTN across products now in the low 60 percent range Sustained growth in demand for cream and remarkable uptake of foam launched in January July 7, 2024... Read More

Eight of nine experts expressed feeling “extremely confident” about prescribing ZORYVE foam to patients of diverse skin and hair types, including individuals with previous hair treatments, based on review of formulation data Crodafos™ CES, used in ZORYVE foam, is suitable for a wide variety of skin and hair types Findings from this formulation review underscore the suitability of ZORYVE foam for use on all affected areas of... Read More

WESTLAKE VILLAGE, Calif., May 03, 2024 (GLOBE NEWSWIRE) - - Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today reported the grant of an aggregate of 160,500 restricted stock units of Arcutis’ common stock as well as options to purchase an aggregate of 117,000 shares of Arcutis’ common stock to 13 newly hired... Read More

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... Read More

WESTLAKE VILLAGE, Calif., April 10, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage company focused on developing meaningful innovations in immuno-dermatology, today announced that David Topper has been appointed Chief Financial Officer (CFO) effective April 10, 2024. He is replacing John Smither, who rejoined Arcutis as interim CFO in August 2023. Mr. Smither will remain at Arcutis... Read More

WESTLAKE VILLAGE, Calif., April 05, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today reported the grant of an aggregate of 58,500 restricted stock units of Arcutis’ common stock to four newly hired employees. These awards were approved by the Compensation Committee of Arcutis’ Board of... Read More

WESTLAKE VILLAGE, Calif., March 28, 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 management will participate in the 23 rd Annual Needham Virtual Healthcare Conference, taking place April 8-11, 2024. Details for the company’s participation are as follows:... Read More

Industry veteran with over 25 years’ experience will continue to advance the company culture and grow the capabilities of Arcutis’ workforce 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... Read More

Investigational roflumilast cream 0.05% met the primary endpoint and all secondary endpoints, showing significant improvement across multiple efficacy endpoints as early as Week 1 39.4% of children treated with roflumilast cream 0.05% achieved a 75% improvement in Eczema Area and Severity Index (EASI-75), a key secondary endpoint New data highlight rapid and significant reduction in itch as early as 24 hours following first... Read More

Findings show that seborrheic dermatitis is a unique inflammatory skin disease with its own molecular signature Suggests skin barrier disruption in seborrheic dermatitis is distinct with its own disease-specific pattern SAN DIEGO, Calif., March 09, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in... Read More

WESTLAKE VILLAGE, Calif., March 05, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today reported the grant of an aggregate of 12,000 restricted stock units of Arcutis’ common stock to two newly hired employees. These awards were approved by the Compensation Committee of Arcutis’ Board of... Read More

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... Read More

Late breaking sessions to highlight new data from the INTEGUMENT-PED trial evaluating roflumilast cream 0.05% in children ages 2-5 with atopic dermatitis New patient-reported outcomes including pruritus data from two pooled Phase 3 trials (DERMIS-1 and DERMIS-2) of ZORYVE ® (roflumilast) cream 0.3% in plaque psoriasis New efficacy and patient-reported outcome data of ZORYVE (roflumilast) topical foam, 0.3%, in seborrheic... Read More

WESTLAKE VILLAGE, Calif., Feb. 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 Arcutis management will participate in the TD Cowen 44 th Annual Health Care Conference. Details for the company’s participation are as follows: Fireside Chat Date: Monday, March 4, 2024... Read More

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... Read More

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... Read More

Arcutis to receive a $25 million upfront payment, and is eligible to receive potential development and commercial milestone payments (totaling $40 million), as well as tiered, double-digit royalties Agreement offers pathway to potentially offering a novel non-steroidal topical option to the millions of Japanese patients suffering from inflammatory skin diseases WESTLAKE VILLAGE, Calif. and TOKYO, Feb. 28, 2024 (GLOBE... Read More

Q4 net product revenues for ZORYVE® (roflumilast) cream 0.3% were $13.5 million, a 357% increase compared to the fourth quarter of 2022 and a 67% increase compared to the third quarter of 2023; driven by sequential improvement in gross-to-net (GTN) in the mid 60 percent range, as well as sustained demand growth Received U.S. Food and Drug Administration (FDA) approval for ZORYVE® (roflumilast) topical foam, 0.3%, for the... Read More

Quarterly investor conference call and webcast scheduled for Tuesday, February 27 at 8:30 a.m. ET WESTLAKE VILLAGE, Calif., Feb. 16, 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 its fourth quarter and full year financial results and provide a business... Read More

WESTLAKE VILLAGE, Calif., Feb. 06, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today reported the grant of an aggregate of 33,750 restricted stock units of Arcutis’ common stock to five newly hired employees. These awards were approved by the Compensation Committee of Arcutis’ Board of... Read More

WESTLAKE VILLAGE, Calif., Jan. 31, 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 management will participate in the Guggenheim Healthcare Talks – 6th Annual Biotechnology Conference. Details for the company’s participation are as follows: Fireside Chat Date:... Read More

Novel steroid-free topical foam effectively controls seborrheic dermatitis Once-daily ZORYVE ® (roflumilast) topical foam, 0.3%, is approved to treat seborrheic dermatitis in individuals 9 years of age and older WESTLAKE VILLAGE, Calif., Jan. 29, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in... Read More

First drug approved for seborrheic dermatitis with a new mechanism of action in over two decades available in pharmacies this week Effective, safe, and very well-tolerated steroid-free foam provides rapid disease clearance and significant reduction in itch Seborrheic dermatitis affects more than 10 million people in the United States Management will host conference call on Monday, January 22 at 1:30 pm PST/4:30 pm EST... Read More

New subgroup analysis from STRATUM study shows that individuals with an inadequate response, contraindication, or intolerance to steroids were 3.5 times more likely to achieve IGA Success with ZORYVE foam than an identical vehicle ZORYVE foam provided rapid and significant improvement in quality of life scores in patients 17 years and older Data presented at the 2024 Winter Clinical Dermatology Conference - Hawaii WESTLAKE... Read More

Individual patient response data highlight 91.5% of individuals treated with roflumilast cream had a measurable improvement in Eczema Area and Severity Index (EASI) in just 4 weeks 85% achieved measurable improvement by Week 1 (the earliest timepoint measured) Data presented at the 2024 Winter Clinical Dermatology Conference - Hawaii WESTLAKE VILLAGE, Calif., Jan. 14, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc.... Read More

ZORYVE foam represents a highly effective, safe, well-tolerated, once-daily steroid-free foam for use on all affected areas of the body, including hair-bearing areas, with no limitations on duration of use ZORYVE foam provides rapid disease clearance and significant reduction in itch, one of the most burdensome symptoms of seborrheic dermatitis First drug approved for seborrheic dermatitis with a new mechanism of action in... Read More

WESTLAKE VILLAGE, Calif., Dec. 01, 2023 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today reported the grant of an aggregate of 90,500 restricted stock units of Arcutis’ common stock as well as options to purchase an aggregate of 106,500 shares of Arcutis’ common stock to 7 newly hired... Read More

FDA has set a PDUFA target action date of July 07, 2024 Atopic dermatitis affects approximately 16.5 million adults and 9.6 million children in the United States sNDA supported by positive efficacy and safety data from the pivotal Phase 3 INTEGUMENT-1 and INTEGUMENT-2 trials WESTLAKE VILLAGE, Calif., Nov. 29, 2023 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early commercial-stage biopharmaceutical... Read More

Achieved total revenues of $38.1 million in the third quarter of 2023. Net product revenues for ZORYVE® (roflumilast) cream 0.3% were $8.1 million, a 70% increase compared to the second quarter of 2023, driven by sequential improvement in gross-to-net (GTN) down to the low 70 percent range, as well as continued demand growth Received U.S. Food and Drug Administration (FDA) approval for the expanded indication of ZORYVE in... Read More

WESTLAKE VILLAGE, Calif., Nov. 02, 2023 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today reported the grant of an aggregate of 52,500 restricted stock units of Arcutis’ common stock to eight newly hired employees. These awards were approved by the Compensation Committee of Arcutis’... Read More

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. A live webcast of the call and the... Read More

Individual patient response data highlights 95% of individuals treated with ZORYVE had a measurable improvement in Psoriasis Area and Severity Index (PASI) at Week 8 Over 85% achieved measurable improvement by Week 2 (the earliest timepoint measured) Separately reported new data confirms ZORYVE is well tolerated according to both investigator and patient local tolerability assessments WESTLAKE VILLAGE, Calif., Oct. 20, 2023... Read More

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... Read More

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... Read More

Once-daily, steroid-free roflumilast foam 0.3% demonstrated significant improvements in both scalp and body psoriasis across all efficacy endpoints compared to vehicle New data highlights a significant reduction in scalp itch observed as early as 24 hours following the first application of roflumilast foam, as measured by change in baseline in Scalp Itch-Numeric Rating Score (SI-NRS) Patients reported a significant... Read More

WESTLAKE VILLAGE, Calif., Oct. 06, 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 approved the supplemental new drug... Read More

WESTLAKE VILLAGE, Calif., Oct. 05, 2023 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today reported the grant of inducement awards to L. Todd Edwards, its new Chief Commercial Officer. The Compensation Committee of Arcutis’ Board of Directors granted Mr. Edwards 60,000 restricted stock... Read More

Industry veteran with deep commercial experience in dermatology and immunology Ayisha Jeter appointed Senior Vice President, Marketing and Market Access 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... Read More

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... Read More

Study met the primary endpoint and all secondary endpoints, highly consistent with rapid response from the INTEGUMENT-1 and INTEGUMENT-2 pivotal trials For the primary endpoint, 25.4% of children treated once daily with roflumilast cream 0.05% achieved Investigator Global Assessment (IGA) Success compared to 10.7% of children treated with vehicle (P<0.0001) at Week 4, with significant improvements seen as early as Week 1... Read More

WESTLAKE VILLAGE, Calif., Sept. 15, 2023 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today reported the grant of an aggregate of 39,000 restricted stock units of Arcutis’ common stock to six newly hired employees. These awards were approved by the Compensation Committee of Arcutis’... Read More

Atopic dermatitis is the most common type of eczema, affecting approximately 9.6 million children and 16.5 million adults in the United States In pivotal Phase 3 trials, roflumilast cream demonstrated statistically significant improvements over vehicle on the primary endpoint of Investigator Global Assessment (IGA) Success at Week 4, as well as on key secondary endpoints including rapid improvement in itch Roflumilast cream... Read More

Results for adults and children ages 6 years and older from INTEGUMENT-OLE long-term extension trial highlight that 46.1% and 51.0% of patients who rolled over from the roflumilast cream treatment arm in INTEGUMENT-1 or -2 achieved IGA success at Week 28 and Week 56, respectively Roflumilast cream maintained disease control even when participants switched to twice weekly maintenance dosing schedule Long-term safety and... Read More

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. Details for the company’s participation are as follows: Morgan Stanley 21 st Annual Global Healthcare Conference Fireside Chat... Read More

Company shows advancement toward improving patient care, access and affordability, social capital, drug safety, sustainability, and ethical business practices 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,... Read More

The Cream That Can is a direct-to-consumer ad highlighting that clear skin is possible with ZORYVE ZORYVE is a once-daily, steroid-free cream for individuals with plaque psoriasis 12 years and above that can be used for long-term treatment across all affected areas of the body ZORYVE is included on all three of the largest pharmacy benefit managers in the United States, providing access to 80% of covered commercial lives... Read More

WESTLAKE VILLAGE, Calif., Aug. 18, 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 John W. Smither, who served as Arcutis’ first Chief Financial Officer (CFO) from 2019 to 2021, has been appointed interim CFO effective August 31. He is replacing Scott Burrows, who... Read More

Arcutis to receive $30 million upfront payment and is eligible to receive potential development and commercial milestone payments, as well as double digit tiered royalties 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... Read More

Achieved total revenues of $5.2 million in the second quarter of 2023. Net product revenues for ZORYVE® (roflumilast) cream 0.3% were $4.8 million, a 72% increase compared to the first quarter of 2023, driven by nearly 40% demand growth as well as gross-to-net improvement Continued expansion of commercial payer coverage for ZORYVE in plaque psoriasis with over 130 million commercial lives covered in the United States,... Read More

WESTLAKE VILLAGE, Calif., Aug. 04, 2023 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today reported the grant of an aggregate of 38,500 restricted stock units of Arcutis’ common stock to five newly hired employees. These awards were approved by the Compensation Committee of Arcutis’... Read More

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. The schedule for the press release and... Read More

Coverage at CVS Caremark, the largest pharmacy benefit manager (PBM) in the United States was effective July 5 All three of the largest pharmacy benefit managers in the United States have now included ZORYVE on formulary, providing access to 80% of commercial lives ZORYVE is a once-daily, steroid-free cream for adults and adolescents with plaque psoriasis, including all affected areas of the body and for long-term use... Read More

WESTLAKE VILLAGE, Calif., July 05, 2023 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today reported the grant of an aggregate of 60,250 restricted stock units of Arcutis’ common stock as well as options to purchase an aggregate of 18,000 shares of Arcutis’ common stock to seven newly... Read More

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. Details for the company’s participation are as follows: Goldman Sachs 44 th Annual Global Healthcare Conference Fireside Chat... Read More

WESTLAKE VILLAGE, Calif., June 05, 2023 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today reported the grant of an aggregate of 58,250 restricted stock units of Arcutis’ common stock as well as options to purchase an aggregate of 17,000 shares of Arcutis’ common stock to seven newly... Read More

Senior Vice President and Chief Commercial Officer (CCO) Ken Lock Stepping Down Ayisha Jeter Appointed Interim CCO WESTLAKE VILLAGE, Calif., May 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 a leadership change. Ken Lock, who has served as Senior Vice President... Read More

Achieved net revenues of $2.8 million for ZORYVE® (roflumilast) cream 0.3% in the first quarter of 2023, with unit demand growth nearly doubling quarter-over-quarter Continued expansion of commercial payer coverage for ZORYVE in plaque psoriasis with over 110 million commercial lives covered in the United States Received Health Canada approval of ZORYVE for plaque psoriasis, with launch expected in the coming weeks Completed... Read More

WESTLAKE VILLAGE, Calif., May 05, 2023 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today reported the grant of an aggregate of 84,000 restricted stock units of Arcutis’ common stock as well as options to purchase an aggregate of 15,000 shares of Arcutis’ common stock to nine newly... Read More

A total of 652 children, ages 2 to 5, were enrolled in the study Topline data expected in the third quarter Atopic dermatitis (AD) affects approximately 26 million adults and children in the United States 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... Read More

First novel steroid-free topical with a new mechanism of action approved for plaque psoriasis in over 25 years First ZORYVE approval outside of the U.S. marks key milestone for Arcutis 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... Read More

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. The schedule for the press release and conference... Read More

FDA has set a target action date of December 16, 2023 NDA supported by positive efficacy and safety data from the Phase 2 and pivotal Phase 3 trials of roflumilast foam If approved, roflumilast foam would be the first topical drug for seborrheic dermatitis with a new mechanism of action in over two decades WESTLAKE VILLAGE, Calif., April 18, 2023 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early... Read More

WESTLAKE VILLAGE, Calif., April 12, 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. Details for the company’s participation are as follows: 22 nd Annual Needham Virtual Healthcare Conference Fireside Chat Date:... Read More

WESTLAKE VILLAGE, Calif., April 07, 2023 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today reported the grant of an aggregate of 83,250 restricted stock units of Arcutis’ common stock as well as options to purchase an aggregate of 33,000 shares of Arcutis’ common stock to 10 newly... Read More

Eight additional national and regional health plans are now covering ZORYVE for plaque psoriasis ZORYVE is a once-daily, steroid-free cream approved for use in both adults and adolescents with plaque psoriasis, including all affected areas of the body WESTLAKE VILLAGE, Calif., April 05, 2023 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early commercial-stage company focused on developing meaningful... Read More

New INTEGUMENT-1 and INTEGUMENT-2 data show a rapid and significant reduction in itch as early as 24 hours after the first application of roflumilast cream 0.15% Rapid and significant improvements were achieved including individuals reaching a 75% reduction of Eczema Area and Severity Index (EASI-75) as early as Week 1 and in Investigator Global Assessment (IGA) Success as early as Week 2 In both studies, roflumilast cream... Read More

Late breaking session to highlight new data from the INTEGUMENT Phase 3 trials evaluating roflumilast cream in atopic dermatitis New national survey insights depicting disease burden, path to diagnosis and treatment patterns for seborrheic dermatitis New clinical safety and efficacy data of topical roflumilast in patients with seborrheic dermatitis and psoriasis New safety and pigmentation data for roflumilast foam in... Read More

WESTLAKE VILLAGE, Calif., March 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 the grant of an aggregate of 27,550 restricted stock units of Arcutis’ common stock to four newly hired employees. These awards were approved by the Compensation Committee of Arcutis’... Read More

Achieved net revenues of $3.0 million for ZORYVE® (roflumilast) cream 0.3% in the first full quarter since the August 2022 launch, driven by continued unit demand growth Secured expanded commercial payer coverage for ZORYVE in plaque psoriasis with the second of the top three pharmacy benefit managers in the U.S., as well as an additional national health plan Announced positive topline results from INTEGUMENT-1 and... Read More

Seborrheic dermatitis is an inflammatory skin disease affecting more than 10 million individuals in the United States If approved, roflumilast foam would be the first topical drug for seborrheic dermatitis with a new mechanism of action in over two decades In a pivotal Phase 3 trial, 80% of individuals treated with roflumilast foam achieved IGA Success at Week 8 Roflumilast foam was well-tolerated with a favorable safety and... Read More