Arcutis Biotherapeutics

Arcutis Biotherapeutics, Inc. engages in the development and commercialization of treatments for dermatological diseases. Its pipeline consists of topical treatments for plaque psoriasis, atopic dermatitis, hand eczema, vitiligo, scalp psoriasis, alopecia areata, and seborrheic dermatitis. The company was founded by Bhaskar Chaudhuri and David W. Osborne in June 2016 and is headquartered in Westlake Village, CA.

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Arcutis Biotherapeutics reports successful 2022 performance and growth strategies

Arcutis Biotherapeutics showcased strong performance in 2022, with ZORYVE's success and pipeline progress driving revenue growth. The company's strategic focus on non-steroidal treatments aligns with changing standards of care and patient preferences. Challenges in maintaining gross-to-net and competition comparisons are areas of focus for sustainable growth.

Arcutis Biotherapeutics reports strong Q1 performance and growth opportunities

Arcutis Biotherapeutics showcased strong performance in Q1 2023, driven by ZORYVE's growth and expanding commercial coverage.
Despite challenges with gross-to-net dynamics and operational issues, the company remains confident in demand growth and product feedback.
Strategic initiatives focusing on market penetration, education, and partnerships position Arcutis well for future growth and product success.
Expansion into Canada, pricing strategy alignment, and disease awareness efforts offer promising opportunities for market expansion and acceptance.

Arcutis Biotherapeutics excels in Q2 with ZORYVE's growth and market expansion

Arcutis Biotherapeutics delivered a strong Q2 performance driven by ZORYVE's successful launch and coverage expansion, positioning the company for continued growth in Q3 and Q4.
Despite facing challenges in physician adoption and managing expenses, Arcutis benefits from key strengths like broad market access, positive physician feedback, and a robust patent estate.
With opportunities to capitalize on key payer agreements, expand into new indications, and drive market differentiation, Arcutis is poised for strategic growth and market expansion in the dermatology sector.

Arcutis Biotherapeutics excels in Q3, eyes market expansion opportunities

Arcutis Biotherapeutics showcased strong financial performance and key achievements in Q3 2023.
The successful ZORYVE launch and positive Phase III data highlight growth potential.
Strategic partnerships and market expansion plans position the company for future success.
Efforts to drive ZORYVE utilization and navigate market challenges are key focus areas.

Arcutis Biotherapeutics excels in Q4, poised for market expansion

Arcutis Biotherapeutics delivered strong financial performance and market acceptance in Q4 2023.
The company's focus on expanding its product portfolio and market reach bodes well for future growth.
Challenges in coverage negotiations and patient engagement require strategic solutions for sustained success.
Overall, Arcutis is well-positioned to capitalize on market opportunities and drive continued growth.

Arcutis Biotherapeutics reports strong Q1 performance and eyes market expansion

Arcutis Biotherapeutics anticipates sustained growth in 2024 and beyond, aiming to positively impact patients with chronic dermatologic diseases.
The company's focus on partnerships, market access optimization, and product expansion positions them well for future success in the dermatology market.
Despite challenges such as regulatory milestones and partnership negotiations, Arcutis remains confident in their ability to navigate these hurdles and drive continued growth.

Arcutis Biotherapeutics excels in Q2 2024, poised for growth

Arcutis Biotherapeutics delivered a strong performance in Q2 2024, driven by the success of ZORYVE products and strategic financial management.
While facing challenges in market expansion and operational efficiency, the company's focus on growth opportunities and profitability strategies bode well for future success.
Overall, Arcutis Biotherapeutics remains well-positioned to capitalize on market opportunities, expand product reach, and drive sustained revenue growth.

Arcutis Biotherapeutics excels in Q3, eyes growth through partnerships

Arcutis Biotherapeutics demonstrated strong sales growth, improved market access, and product label expansions in Q3 2024, positioning the company for future success.
While challenges like achieving breakeven and optimizing partnerships exist, opportunities from upcoming approvals and market trends present avenues for sustained growth.
Overall, Arcutis Biotherapeutics' strategic initiatives and performance in Q3 underscore its potential for long-term success and market leadership in dermatology.

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WESTLAKE VILLAGE, Calif., Sept. 26, 2022 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc.  (Nasdaq: ARQT), an early-stage commercial company focused on developing meaningful innovations in immuno-dermatology, today announced positive topline results from the ARRECTOR Pivotal Phase 3 trial evaluating roflumilast foam 0.3%, a once-daily, non-steroidal topical phosphodiesterase-4 (PDE4) inhibitor, for the treatment of adults and adolescents with scalp and body psoriasis. The study met its co-primary endpoints of S-IGA Success and B-IGA Success, and all secondary endpoints.

Arcutis Announces Positive Topline Results from ARRECTOR Pivotal Phase 3 Trial of Roflumilast Foam 0.3% in Scalp and Body Psoriasis

WESTLAKE VILLAGE, Calif., Sept. 20, 2022 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early-stage commercial company focused on developing meaningful innovations in immuno-dermatology, today announced that the Journal of the American Medical Association (JAMA) published positive results from two pivotal Phase 3 studies (DERMIS-1 and DERMIS-2) evaluating roflumilast cream 0.3% as a once daily, topical treatment for chronic plaque psoriasis. The study, which was published in the September 20 issue of JAMA, found that treatment with roflumilast cream resulted in significant improvements across multiple efficacy endpoints including plaque clearance and itch at eight weeks in adults and adolescents with plaque psoriasis compared to vehicle. ZORYVE was approved for topical use of plaque psoriasis, including intertriginous psoriasis, for use in adults and adolescents in July 2022.

Journal of the American Medical Association Publishes Roflumilast Cream 0.3% Results from Pivotal DERMIS-1 and -2 Phase 3 Trials in Plaque Psoriasis

Shares of dermatology biopharma Arcutis Biotherapeutics, Inc. fell 16% the day after receiving its first FDA approval for ZORYVE (roflumilast) in the treatment of plaque psoriasis. The market seemed to be anticipating a secondary offering, which was executed three days later at $20 per share, likely obviating the need to ever return to the capital markets.

Arcutis Biotherapeutics: A Name To Accumulate

Zoryve (roflumilast cream) was approved by the FDA to treat psoriasis on August 1, 2022. The phase 3 STRATUM trial met the endpoint and an NDA will be submitted to FDA for roflumilast foam to be approved for the treatment of seborrheic dermatitis.

Arcutis Biotherapeutics: Roflumilast May Be A Pipeline In A Molecule

WESTLAKE VILLAGE, Calif. and MILAN, Italy, Sept. 09, 2022 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc.  (Nasdaq: ARQT), an early-stage commercial company focused on developing meaningful innovations in immuno-dermatology, today announced new data from the STRATUM pivotal Phase 3 trial investigating roflumilast foam as a potential treatment for children ages 9 and above and adults with moderate to severe seborrheic dermatitis were presented orally at the Academy of Dermatology and Venereology (EADV) Congress. 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.

New Data from Arcutis' STRATUM Pivotal Phase 3 Trial of Roflumilast Foam 0.3% in Seborrheic Dermatitis Presented at European Academy of Dermatology and Venereology (EADV) Congress

First exit for LifeArc Ventures, the largest investor in Ducentis, recognising the transformational potential of its science Ducentis lead pre-clinical asset DS-234 is being developed for the treatment of atopic dermatitis, a significantly underserved market Agreement values Ducentis at up to $400 million, including upfront cash payment of $16 million and Arcutis stock valued at approximately $14 million, plus future contingent payments based on development and commercial success LONDON , Sept. 8, 2022 /PRNewswire/ -- LifeArc today announced that its portfolio company DucentisBioTherapeutics, a preclinical-stage biotechnology company focused on developing novel therapies for inflammation and autoimmune diseases, has been acquired by ArcutisBiotherapeutics, Inc. (NASDAQ: ARQT), a California-based early commercial stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology.

LifeArc portfolio company Ducentis BioTherapeutics acquired by Arcutis Biotherapeutics for up to $400 million

WESTLAKE VILLAGE, Calif., Sept. 07, 2022 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc.  (Nasdaq: ARQT), an early commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced it has entered into an agreement to acquire Ducentis BioTherapeutics Ltd., a privately held, preclinical-stage biotechnology company focused on developing novel therapies for inflammation and autoimmune diseases. Under the terms of the share purchase agreement, Arcutis will acquire the outstanding shares of Ducentis for an upfront cash payment of approximately $16 million and Arcutis stock valued at approximately $14 million, as well as future contingent payments based on development and commercial success. Closing of the transaction will be subject to customary closing conditions.

Arcutis Announces Acquisition of Ducentis BioTherapeutics Ltd.

WESTLAKE VILLAGE, Calif., Sept. 06, 2022 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc.  (Nasdaq: ARQT), an early-stage commercial company focused on developing meaningful innovations in immuno-dermatology, today announced that four abstracts for Arcutis' topical roflumilast program in seborrheic dermatitis and psoriasis will be presented at European Academy of Dermatology and Venereology (EADV) Congress, held September 7-10, 2022, in Milan and virtually. Specifically, new data from the STRATUM Phase 3 pivotal trial of roflumilast foam in seborrheic dermatitis will be presented in a late-breaking news session.

New Data from Arcutis' Topical Roflumilast Clinical Program Presented at the European Academy of Dermatology and Venereology (EADV) Congress

WESTLAKE VILLAGE, Calif., Sept. 02, 2022 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc.  (Nasdaq: ARQT), an early-stage commercial company focused on developing meaningful innovations in immuno-dermatology, today announced that Neha Krishnamohan has been appointed to the Arcutis Board of Directors and as a member of the audit committee. Following the appointment, the Board will be composed of 10 directors.

Arcutis Announces Appointment of Neha Krishnamohan to Board of Directors

Launched during Psoriasis Action Month, campaign provides tips and tools for speaking about psoriasis with healthcare providers, family, and friends WESTLAKE VILLAGE, Calif. , Aug. 30, 2022 /PRNewswire/ -- Arcutis Biotherapeutics, Inc. (NASDAQ: ARQT) today announced the launch of an educational campaign designed to raise awareness about the physical and emotional impact of plaque psoriasis and empower those living with the disease to have open, honest conversations with their healthcare providers, family, and friends.

NEW CAMPAIGN FROM ARCUTIS AIMS TO EXPOSE THE IMPACT OF PSORIASIS ON PHYSICAL, MENTAL, AND EMOTIONAL WELLBEING

The mean of analysts' price targets for Arcutis Biotherapeutics, Inc. (ARQT) points to a 134.2% upside in the stock. While this highly sought-after metric has not proven reasonably effective, strong agreement among analysts in raising earnings estimates does indicate an upside in the stock.

Wall Street Analysts Believe Arcutis Biotherapeutics, Inc. (ARQT) Could Rally 134%: Here's is How to Trade

WESTLAKE VILLAGE, Calif., Aug. 23, 2022 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno- dermatology, today announced the enrollment of the last subject in its INTEGUMENT-2 pivotal Phase 3 trial of roﬂumilast cream 0.15% in adults and children with atopic dermatitis (AD). Roﬂumilast cream is a once daily topical formulation of roﬂumilast, a highly potent and selective phosphodiesterase type 4 inhibitor (PDE4). The Company completed enrollment in an identically designed pivotal Phase 3 trial, INTEGUMENT-1, earlier in August 2022, with topline data from both trials expected by end of 2022. If successful, the Company believes that the trials will provide a suﬃcient basis to submit a supplemental New Drug Application (sNDA) for roﬂumilast cream 0.15% for the treatment of mild to moderate AD in individuals six years of age and older in 2023.

Arcutis Completes Enrollment in INTEGUMENT-2 Pivotal Phase 3 Trial of Roﬂumilast Cream in Atopic Dermatitis

WESTLAKE VILLAGE, Calif., Aug. 22, 2022 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc.  (Nasdaq: ARQT), an early commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced that Arcutis Cares, the first ever patient assistance program (PAP) for a topical psoriasis product, is open for enrollment. Financially eligible individuals who are uninsured or underinsured may apply for the program to receive ZORYVE (roflumilast) cream 0.3% at no cost.‡

Arcutis Announces Arcutis Cares™ Patient Assistance Program (PAP) For Financially Qualified Uninsured and Underinsured Patients

The mean of analysts' price targets for Arcutis Biotherapeutics, Inc. (ARQT) points to a 122.8% upside in the stock. While this highly sought-after metric has not proven reasonably effective, strong agreement among analysts in raising earnings estimates does indicate an upside in the stock.

Can Arcutis Biotherapeutics, Inc. (ARQT) Climb 123% to Reach the Level Wall Street Analysts Expect?

WESTLAKE VILLAGE, Calif., Aug. 10, 2022 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (NASDAQ: ARQT), an early commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced that ZORYVE (roflumilast) cream 0.3% for topical use is now available in the United States for the treatment of plaque psoriasis in people aged 12 and older. As the first and only topical phosphodiesterase-4 (PDE4) inhibitor approved for the treatment of plaque psoriasis, ZORYVE clears plaques and reduces itch rapidly in all affected areas of the body, including intertriginous areas (areas of skin-to-skin contact). Featuring HydroARQ Technology™, a patient-friendly formulation that absorbs quickly and spreads easily, ZORYVE is an effective, well-tolerated, once-daily steroid-free cream with no restrictions on duration of use.

Arcutis Launches ZORYVE™ (Roflumilast) Cream 0.3% in the United States for Treatment of Plaque Psoriasis in Individuals Age 12 and Older

WESTLAKE VILLAGE, Calif., Aug. 04, 2022 (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, 2022, and provided a business update.

Arcutis Announces Second Quarter 2022 Financial Results and Provides Business Update

WESTLAKE VILLAGE, Calif., Aug. 04, 2022 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc.  (Nasdaq: ARQT), an early commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced the enrollment of the last subject in its INTEGUMENT-1 pivotal Phase 3 trial of roflumilast cream 0.15% in adults and children with atopic dermatitis (AD). Roflumilast cream is a once daily topical formulation of roflumilast, a highly potent and selective phosphodiesterase type 4 inhibitor (PDE4). The Company is continuing enrollment in an identically designed pivotal Phase 3 trial, INTEGUMENT-2, with topline data from both trials expected by end of 2022. If successful, the Company believes that the trials will provide a sufficient basis to submit a supplemental New Drug Application (sNDA) for roflumilast cream 0.15% for the treatment of mild to moderate AD in individuals age six years and older in 2023.

Arcutis Completes Enrollment in INTEGUMENT-1 Pivotal Phase 3 Trial of Roflumilast Cream in Atopic Dermatitis

WESTLAKE VILLAGE, Calif., Aug. 02, 2022 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (“Arcutis”) (Nasdaq: ARQT), an early commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced the pricing of its underwritten public offering of 7,500,000 shares of its common stock at a public offering price of $20.00 per share, representing a premium to the closing price of $19.50 per share on August 2, 2022. In addition, Arcutis has granted the underwriters a 30-day option to purchase up to an additional 1,125,000 shares of common stock at the public offering price, less underwriting discounts and commissions. The gross proceeds to Arcutis from the offering are expected to be $150.0 million, before deducting underwriting discounts and commissions and estimated 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 August 5, 2022.

Arcutis Biotherapeutics Announces Pricing of Public Offering of Common Stock

WESTLAKE VILLAGE, Calif., Aug. 02, 2022 (GLOBE NEWSWIRE) --  Arcutis Biotherapeutics, Inc. (“Arcutis”) (Nasdaq: ARQT), an early 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. All of the shares in the 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 proposed 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% of the shares of common stock offered in the public offering at the public offering price.

Arcutis Biotherapeutics Announces Proposed Public Offering of Common Stock

WESTLAKE VILLAGE, Calif., Aug. 01, 2022 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc.  (Nasdaq: ARQT), an early-stage commercial biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, will host a conference call for investors today at 8:30 a.m. EDT to discuss the U.S. Food and Drug Administration (FDA) approval of ZORYVE (roflumilast) cream 0.3% for treatment of plaque psoriasis, including intertriginous areas, in patients 12 years of age and older.

Arcutis to Host Investor Conference Call Today to Discuss the FDA Approval of ZORYVE™ (roflumilast) Cream 0.3% for Plaque Psoriasis

WESTLAKE VILLAGE, Calif., July 29, 2022 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (NASDAQ: ARQT), an early commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, announced today that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for ZORYVE (roflumilast) cream 0.3% for the treatment of plaque psoriasis, including intertriginous areas, in patients 12 years of age or older. The first and only topical phosphodiesterase-4 (PDE4) inhibitor approved for the treatment of plaque psoriasis, ZORYVE provides rapid clearance of psoriasis plaques and reduces itch in all affected areas of the body. ZORYVE — a once-daily, steroid-free cream in a safe and well tolerated, patient-friendly formulation — is uniquely formulated to simplify disease management for people living with plaque psoriasis.

FDA Approves Arcutis' ZORYVE™ (Roflumilast) Cream 0.3% For the Treatment of Plaque Psoriasis in Individuals Age 12 and Older

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WESTLAKE VILLAGE, Calif., July 11, 2022 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), today announced that Health Canada has accepted for review the New Drug Submission (NDS) for roflumilast cream 0.3% for the treatment of plaque psoriasis in adults and adolescents. Roflumilast cream (ARQ-151) is a once-daily topical formulation of roflumilast, a highly potent and selective inhibitor of phosphodiesterase type 4 (PDE4), an enzyme that drives overactive immune responses. PDE4 is an established target in dermatology. The target action date is April 30, 2023.

Arcutis Biotherapeutics Announces Health Canada Accepts for Review the New Drug Submission for Roflumilast Cream for Adults and Adolescents with Plaque Psoriasis

A pending FDA review and promising clinical trial data brings blockbuster potential.

Could 2023 Be a Breakout Year for This Pharma Stock?

WESTLAKE VILLAGE, Calif., June 06, 2022 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc.  (Nasdaq: ARQT), a late-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced positive topline results from the STRATUM pivotal Phase 3 trial investigating roflumilast foam as a potential treatment for adolescents and adults with moderate to severe seborrheic dermatitis. Roflumilast foam 0.3%, an investigational once-daily topical foam formulation of a highly potent and selective phosphodiesterase type 4 (PDE4) inhibitor being developed to treat inflammatory dermatoses, particularly in hair-bearing areas of the body such as the scalp, demonstrated significant improvements based on IGA Success and other endpoints.

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