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

4 - Arcutis Biotherapeutics, Inc. (0001787306) (Issuer)

4 - Arcutis Biotherapeutics, Inc. (0001787306) (Issuer)

4 - Arcutis Biotherapeutics, Inc. (0001787306) (Issuer)

4 - Arcutis Biotherapeutics, Inc. (0001787306) (Issuer)

4 - Arcutis Biotherapeutics, Inc. (0001787306) (Issuer)

4 - Arcutis Biotherapeutics, Inc. (0001787306) (Issuer)

4 - Arcutis Biotherapeutics, Inc. (0001787306) (Issuer)

4 - Arcutis Biotherapeutics, Inc. (0001787306) (Issuer)

4 - Arcutis Biotherapeutics, Inc. (0001787306) (Issuer)

4 - Arcutis Biotherapeutics, Inc. (0001787306) (Issuer)

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

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

4 - Arcutis Biotherapeutics, Inc. (0001787306) (Issuer)

4 - Arcutis Biotherapeutics, Inc. (0001787306) (Issuer)

4 - Arcutis Biotherapeutics, Inc. (0001787306) (Issuer)

4 - Arcutis Biotherapeutics, Inc. (0001787306) (Issuer)

4 - Arcutis Biotherapeutics, Inc. (0001787306) (Issuer)

4 - Arcutis Biotherapeutics, Inc. (0001787306) (Issuer)

4 - Arcutis Biotherapeutics, Inc. (0001787306) (Issuer)

4 - Arcutis Biotherapeutics, Inc. (0001787306) (Issuer)

4 - Arcutis Biotherapeutics, Inc. (0001787306) (Issuer)

4 - Arcutis Biotherapeutics, Inc. (0001787306) (Issuer)

WESTLAKE VILLAGE, Calif., July 23, 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 report second quarter 2025 financial results and provide a business update on Wednesday, August 6, 2025 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 live webcast of the call and the presentation materials will be available on the "Events" section of the Company's website. An archived replay of the webcast will be available on the Arcutis investor website following

WESTLAKE VILLAGE, Calif., July 03, 2025 (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 14,000 restricted stock units of Arcutis' common stock to two newly hired employees. These awards were approved by the Compensation Committee of Arcutis' Board of Directors and granted under the Arcutis Biotherapeutics, Inc. 2022 Inducement Plan, with a grant date of July 1, 2025, as an inducement material to the new employees entering into employment with Arcutis, in accordance with Nasdaq Listing Rule 5635(c)(4). The restricted

The American Academy of Dermatology (AAD) provided evidence-based recommendation for the use of ZORYVE® (roflumilast) cream 0.15% in adults with mild to moderate atopic dermatitis (AD)Recommendation reflects ZORYVE's proven efficacy, safety, and tolerability as a next-generation, steroid-free, topical phosphodiesterase-4 (PDE4) inhibitorAmong newly evaluated branded topical therapies, ZORYVE is the only treatment with a strong recommendation for adults with mild to moderate atopic dermatitis in AAD's focused guideline updateZORYVE is the first FDA-approved branded topical PDE4 inhibitor indicated for AD, plaque psoriasis, and seborrheic dermatitisAD impacts over 16 million adults in the Unit

Four-week Phase 2 study to evaluate investigational, once-daily ZORYVE .05% in infants as young as 3 months to less than 2 years with atopic dermatitisAtopic dermatitis impacts 9.6 million children in the United States; up to 60% of children with atopic dermatitis develop symptoms within their first year WESTLAKE VILLAGE, Calif., June 10, 2025 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced that the first child has been enrolled in a Phase 2 open-label study, INTEGUMENT-INFANT, evaluating the safety and tolerability of investigational ZORYVE (ro

WESTLAKE VILLAGE, Calif., June 06, 2025 (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 72,000 restricted stock units of Arcutis' common stock to nine 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 June 2, 2025, as an inducement material to the new employees entering into employment with Arcutis, in accordance with Nasdaq Listing Rule 5635(c)(4). The restricted

New data from the Phase 3 INTEGUMENT-OLE long-term open label study show durable improvement in the signs and symptoms of atopic dermatitis (AD), including almost half of participants achieving no or minimal itch with ZORYVE cream 0.15% or ZORYVE cream 0.05%New data demonstrate that for children ages 2 to 5 who achieved disease clearance and switched to proactive twice-weekly application of investigational ZORYVE cream 0.05%, the median duration of disease control was 238 daysConsistent efficacy, safety, and tolerability profile observed with ZORYVE cream WESTLAKE VILLAGE, Calif., June 06, 2025 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT), a commercial-stage biopharmace

WESTLAKE VILLAGE, Calif., May 29, 2025 (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 46th Annual Global Healthcare Conference, taking place June 9-11, 2025. Details for the company's participation are as follows:        Fireside Chat Date: Tuesday, June 10, 2025        Fireside Chat Time: 4:00 pm EDT The webcast for this conference may be accessed at the "Events" section of the Company's website. A replay of the webcast will be available on the Arcutis website for 180 days followin

Once-daily ZORYVE foam provides powerful clearance and rapid itch relief from head to toe with no limitation on duration of useMore than half of the nearly 9 million people in the United States with plaque psoriasis experience scalp involvementHealthcare providers and individuals with plaque psoriasis can now choose ZORYVE foam or cream to treat plaque psoriasis anywhere it appears on the bodyFifth FDA approval for ZORYVE in less than three yearsManagement will host an investor event with a key opinion leader on Monday, June 2 at 8:00 am ET/5:00 am PT WESTLAKE VILLAGE, Calif., May 22, 2025 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT), a commercial-stage biopharmaceutica

Arcutis convened the Genital Psoriasis Wellness Consortium, a multidisciplinary group of clinicians who are experts in their fieldsPublication includes 14 consensus statements aimed at improving diagnosis, treatment, outcomes, and shared decision-makingGenital involvement occurs in approximately two-thirds of the nine million individuals with plaque psoriasis WESTLAKE VILLAGE, Calif., May 15, 2025 (GLOBE NEWSWIRE) --  Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced the publication of 14 consensus statements from the Genital Psoriasis Wellness Consortium on the impa

Once-daily, investigational ZORYVE foam 0.3%, rapidly improved psoriasis of the scalp and body, including itch, when used as a monotherapy66.4% of individuals treated with ZORYVE foam achieved Scalp-Investigator Global Assessment (S-IGA) Success at Week 845.5% of individuals treated with ZORYVE foam achieved Body-Investigator Global Assessment (B-IGA) Success at Week 8Efficacy and safety results were consistent with Phase 2 results of ZORYVE foam 0.3% in adults and adolescents 12 years of age and olderSupplemental New Drug Application (sNDA) for investigational ZORYVE foam 0.3% for psoriasis is under review with U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (P

Goldman initiated coverage of Arcutis Biotherapeutics with a rating of Neutral and set a new price target of $18.00

H.C. Wainwright initiated coverage of Arcutis Biotherapeutics with a rating of Buy and set a new price target of $19.00

Jefferies initiated coverage of Arcutis Biotherapeutics with a rating of Buy and set a new price target of $15.00

Mizuho upgraded Arcutis Biotherapeutics from Neutral to Buy and set a new price target of $8.00 from $4.00 previously

Mizuho downgraded Arcutis Biotherapeutics from Buy to Neutral and set a new price target of $4.00 from $57.00 previously

Goldman downgraded Arcutis Biotherapeutics from Buy to Neutral and set a new price target of $6.00 from $32.00 previously

Needham initiated coverage of Arcutis Biotherapeutics with a rating of Buy and set a new price target of $46.00

Goldman initiated coverage of Arcutis Biotherapeutics with a rating of Buy and set a new price target of $45.00

Morgan Stanley reiterated coverage of Arcutis Biotherapeutics with a rating of Overweight and set a new price target of $37.00 from $35.00 previously

Morgan Stanley reiterated coverage of Arcutis Biotherapeutics with a rating of Overweight and set a new price target of $35.00 from $50.00 previously

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

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WESTLAKE VILLAGE, Calif., July 23, 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 report second quarter 2025 financial results and provide a business update on Wednesday, August 6, 2025 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 live webcast of the call and the presentation materials will be available on the "Events" section of the Company's website. An archived replay of the webcast will be available on the Arcutis investor website following

Q1 2025 net product revenue for ZORYVE® (roflumilast) was $63.8 million, a 196% increase compared to Q1 of 2024, and a 2% decrease compared to Q4 of 2024, due to typical first-quarter deductible resets and insurance changes, and excluding the non-recurring reduction in reserves for product return of $4.1 million reported in Q4 2024Continued demand growth for ZORYVE of 10%, solidifying its position as most prescribed branded non-steroidal topical treatment across three major inflammatory skin conditionsAll three largest national Pharmacy Benefit Managers (PBMs) covering entire ZORYVE portfolio and Medicaid coverage continues to expandOn April 3, 2025, the patent litigation against Padagis was

WESTLAKE VILLAGE, Calif., April 17, 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 report first quarter 2025 financial results and provide a business update on Tuesday, May 6, 2025 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 live webcast of the call and the presentation materials will be available on the "Events" section of The Company's website. An archived replay of the webcast will be available on the Arcutis investor website following th

WESTLAKE VILLAGE, Calif., Feb. 25, 2025 (GLOBE NEWSWIRE) -- Q4 2024 net product revenue for ZORYVE® (roflumilast) was $69.4 million, a 413% increase compared to Q4 of 2023 and a 55% increase compared to Q3 of 2024; driven by strong portfolio demand growth and including a non-recurring adjustment of $4.1 million due to a reduction in reserves for product returnsFull Year 2024 net product revenue for ZORYVE was $166.5 million, an increase of 471% over the prior year, setting the stage for sustained growth and strong financial position in 2025ZORYVE is now the most prescribed branded non-steroidal topical treatment across three major inflammatory skin conditions combined in the United StatesS

Preliminary unaudited product revenue for the fourth quarter of 2024 is expected to be approximately $63 million, up approximately 366% vs. Q4 2023 and 41% vs. Q3 2024Preliminary unaudited product revenue for the full-year 2024 is expected to be approximately $160 million, up approximately 449% vs. 2023Robust unit growth across the portfolio with gross-to-net (GTN) similar to prior quarterPreliminary unaudited cash, cash equivalents, restricted cash, and marketable securities as of December 31, 2024 are expected to be approximately $229 millionCompany to release complete fourth quarter and full year 2024 financial results and host a conference call and webcast on February 25, 2025 at 4:30 p.

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 '24Continued 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 quarterSustained growth in prescriptions for both cream and foam, with total U.S. franchise unit demand increase of 25% quarter over quarterSupplemental New Drug Application (sNDA) for ZORYVE foam accepted by Food & Drug Administration (FDA) for the treatment of scalp and body psoriasis in adults and adolesc

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

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 '24Continued 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 quarterSustained growth in prescriptions for both cream and foam, with total U.S. franchise unit demand increase of 42% quarter over quarterEntered into ZORYVE co-promotion agreement with Kowa Pharmaceuticals America, Inc., expanding promotional efforts to primary care and pediatric offices in the United StatesSubmitted S

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 conference call and webcast the same day at 4:30 p.m. ET. A live webcast of the call and the presentation materials will be available on the "Events" section of the Company's website. An archived replay of the webcast will be available on the Arcutis investor website follow

Once-daily, effective, safe, and well-tolerated ZORYVE cream now commercially availableProvides 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 skinAtopic dermatitis is the most common type of eczema, affecting approximately 9.6 million children and 16.5 million adults in the United StatesManagement will host an investor event with a key opinion leader on Monday, July 29 at 8:30 am EDT/5:30 am PDT WESTLAKE VILLAGE, Calif., July 29, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT), a commercial-stage biopharmaceutical company focused on developing meani