Submission status for ARCUTIS BIOTHERAPEUTICS INC's drug ZORYVE (ORIG-1) with active ingredient ROFLUMILAST has changed to 'Approval' on 12/15/2023. Application Category: NDA, Application Number: 217242, Application Classification: Type 3 - New Dosage Form

Submission status for ARCUTIS BIOTHERAPEUTICS INC's drug ZORYVE (ORIG-1) with active ingredient ROFLUMILAST has changed to 'Approval' on 12/15/2023. Application Category: NDA, Application Number: 217242, Application Classification: Type 3 - New Dosage Form and Type 4 - New Combination

144 - Arcutis Biotherapeutics, Inc. (0001787306) (Subject)

144 - Arcutis Biotherapeutics, Inc. (0001787306) (Subject)

10-Q - Arcutis Biotherapeutics, Inc. (0001787306) (Filer)

8-K - Arcutis Biotherapeutics, Inc. (0001787306) (Filer)

144 - Arcutis Biotherapeutics, Inc. (0001787306) (Subject)

10-Q/A - Arcutis Biotherapeutics, Inc. (0001787306) (Filer)

144 - Arcutis Biotherapeutics, Inc. (0001787306) (Subject)

8-K - Arcutis Biotherapeutics, Inc. (0001787306) (Filer)

144 - Arcutis Biotherapeutics, Inc. (0001787306) (Subject)

144 - Arcutis Biotherapeutics, Inc. (0001787306) (Subject)

Industry veteran with deep commercial experience in dermatology and immunologyAyisha 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 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. "We are t

Senior Vice President and Chief Commercial Officer (CCO) Ken Lock Stepping DownAyisha 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 and Chief Commercial Officer (CCO) since October 2019, is stepping down to attend to personal matters effective June 2, 2023. During this transition period, Arcutis' Vice President of Market Access, Ayisha Jeter, has been appointed interim CCO. Mr. Lock's contributions t

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. "On behalf of our entire team, we'd like to thank Keith for his considerable contributions to our efforts in establishing Arcutis as a le

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. "We thank Ricky for his leadership over the past three years," commented Patrick Heron, Chairman of the Arcutis Board of Directors. "He made significant contr

Eleusis, a clinical-stage life science company dedicated to unlocking the full therapeutic potential of psychedelics, today announced the appointment of four highly experienced business leaders to its board of directors. The new directors' deep expertise building high-growth, high-impact life science companies complements Eleusis's world-class leadership team. The appointees include: David Socks, former CEO of Phathom Pharmaceuticals, joining as Chair of the board Robert Hershberg, M.D., Ph.D., former CBO and CSO of Celgene John Tucker, CEO of SC Pharmaceuticals Esther van den Boom, Managing Partner at van den Boom & Associates "We are delighted to welcome these four exceptional d

WESTLAKE VILLAGE, Calif., June 09, 2021 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a late-stage biopharmaceutical company focused on developing and commercializing treatments for unmet needs in immune-mediated dermatological diseases and conditions, or immuno-dermatology, today announced that Sue-Jean Lin has been appointed to the Arcutis Board of Directors effective June 9, 2021, and that Jonathan Silverstein, J.D. has decided to step down from the Board for personal reasons. “We thank Jonathan for his outstanding contributions to Arcutis,” commented Patrick Heron, Chairman of the Arcutis Board of Directors. “His leadership was instrumental in driving the continue

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 familiesZORYVE 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 24-hours of first applicationData presented as an oral presentation at the American College of Allergy, Asthma and Immunology (ACAAI) 2024 Annual Scientific Meeting WESTLAKE VILLAGE, Calif., Oct. 24, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT),

Quarterly investor conference call and webcast is scheduled for Wednesday, November 6 at 4:30 p.m. ETArcutis 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 immuno-dermatology, today announced that it will report third quarter 2024 financial results and provide a business update on Wednesday, November 6, 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. A

Once-daily, steroid-free foam designed to treat seborrheic dermatitis on all affected areas of the body, including hair-bearing regions such as the scalpClinical 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 dermatitis1ZORYVE foam represents the first topical treatment for seborrheic dermatitis with a new mechanism of action approved in Canada in over 20 years2TORONTO, Oct. 21, 2024 /CNW/ - Arcutis Canada Inc., a commercial-stage company focused on delivering meaningful innovations in immuno-dermatology, is pleased to announce that Health Canada has approved

ZORYVE foam represents the first topical treatment for seborrheic dermatitis with a new mechanism of action approved in Canada in over two decades1Second 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 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 t

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 employees. These awards were approved by the Compensation Committee of Arcutis' Board of Directors and granted under the Arcutis Biotherapeutics, Inc. 2022 Inducement Plan, with a grant date of October 1, 2024, as an inducement material to the new employees entering into emplo

ZORYVE demonstrated consistent efficacy in disease clearance and reduction in itch for individuals with atopic dermatitis (AD) regardless of race, ethnicity, and Fitzpatrick skin typeZORYVE was safe and well tolerated across all subgroupsData presented at the 2024 European Academy of Dermatology & Venereology Congress 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 con

U.S. Food and Drug Administration (FDA) has set a Prescription Drug User Fee Act (PDUFA) target action date of May 22, 2025Almost half of the 9 million individuals in the United States with plaque psoriasis experience involvement of the scalpSupplemental 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 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 ZORY

ZORYVE® (roflumilast) cream 0.15% improved atopic dermatitis (AD) across multiple efficacy endpoints while demonstrating favorable safety and tolerabilityAcross 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 1ZORYVE cream 0.15% rapidly and significantly reduced itch, the most bothersome symptom of ADOnce-daily, ZORYVE cream 0.15% is approved to treat mild to moderate AD in adults and children down to age 6  WESTLAKE VILLAGE, Calif., Sept. 19, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeu

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 Directors and granted under the Arcutis Biotherapeutics, Inc. 2022 Inducement Plan, with a grant date of September 3, 2024, as an inducement material to the new employees entering into employment with Arcutis, in accordance with Nasdaq Listing Rule 5635(c)(4). The rest

ARQ-255 is a topical Janus kinase 1 (JAK1) inhibitor suspension formulated as a potential topical treatment for alopecia areataProprietary 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 occursPhase 1b results expected first half of 2025 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,

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 trialData also show rapid reduction in scalp itch as soon as 24 hours after first applicationZORYVE foam demonstrated a favorable safety and tolerability profileWESTLAKE 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 ZO

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. Details for the event are as follows:Monday, July 29

On Tuesday, the FDA approved Arcutis Biotherapeutics Inc’s (NASDAQ:ARQT) supplemental new drug application (sNDA) for Zoryve (roflumilast) cream, 0.15%, for mild to moderate atopic dermatitis in patients six years of age and older. “Today marks the third FDA approval of a commercial product for Arcutis in just the last two years, and we are thrilled to be able to offer ZORYVE cream 0.15% as a new steroid-free treatment option to children and adults living with AD,” said Frank Watanabe, president and CEO of Arcutis. Arcutis intends to make Zoryve cream 0.15% widely available via key wholesaler and dermatology pharmacy channels as a new treatment option by the end of July. In the firs

Ratings for Arcutis Biotherapeutics (NASDAQ:ARQT) were provided by 4 analysts in the past three months, showcasing a mix of bullish and bearish perspectives. The following table encapsulates their recent ratings, offering a glimpse into the evolving sentiments over the past 30 days and comparing them to the preceding months. Bullish Somewhat Bullish Indifferent Somewhat Bearish Bearish Total Ratings 4 0 0 0 0 Last 30D 1 0 0 0 0 1M Ago 0 0 0 0 0 2M Ago 2 0 0 0 0 3M Ago 1 0 0 0 0 Analysts' evaluations of 12-month price targets offer additional insights, showcasing an average target of $17.5, with a high estimate of $18.00 and a low estimate of $16.00. Observing a 4.48% incr

Needham analyst Serge Belanger reiterates Arcutis Biotherapeutics (NASDAQ:ARQT) with a Buy and maintains $18 price target.

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. Arcutis intends to make ZORYVE cream 0.15% widely available via key wholesaler and dermatology pharmacy channels as a new treatment option by the end of July.

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.

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