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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The FDA approves Arcutis' (ARQT) NDA for Zoryve topical foam 0.3% for treating seborrheic dermatitis in individuals nine years of age and above.

Arcutis (ARQT) Up on FDA Nod for Zoryve in Seborrheic Dermatitis

WESTLAKE VILLAGE, Calif., Dec. 15, 2023 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early commercial-stage company focused on developing meaningful innovations in immuno-dermatology, today announced the U.S. Food and Drug Administration (FDA) has approved the new drug application (NDA) for ZORYVE (roflumilast) topical foam, 0.3% for the treatment of seborrheic dermatitis in individuals 9 years of age and older. ZORYVE foam provides rapid disease clearance and significant reduction in itch, with nearly 80% of individuals achieving the primary efficacy endpoint of IGA Success and just over 50% of individuals reaching complete clearance at Week 8 in the STRATUM trial. ZORYVE is a once-daily steroid-free foam and the first drug approved for seborrheic dermatitis with a new mechanism of action in over two decades.

FDA Approves Arcutis' ZORYVE® (roflumilast) Topical Foam, 0.3% for the Treatment of Seborrheic Dermatitis in Individuals Aged 9 Years and Older

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

FDA Accepts Arcutis' Supplemental New Drug Application for Roflumilast Cream 0.15% for the Treatment of Atopic Dermatitis in Adults and Children Down to Age 6

Arcutis Biotherapeutics, Inc. (ARQT) has become technically an oversold stock now, which implies exhaustion of the heavy selling pressure on it. This, combined with strong agreement among Wall Street analysts in revising earnings estimates higher, indicates a potential trend reversal for the stock in the near term.

After Plunging -35.64% in 4 Weeks, Here's Why the Trend Might Reverse for Arcutis Biotherapeutics, Inc. (ARQT)

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Arcutis faces competition from Otezla and Vtama in the treatment of plaque psoriasis. Topical therapies for psoriasis have limitations and biologics are expensive, limiting their use. Zoryve, Arcutis' approved drug, has seen positive prescription growth and label expansion for children, but sales figures have been lower than expected.

Arcutis Biotherapeutics: Almost There, But Needs Some Fine-Tuning

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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 plaque psoriasis down to the age of 6 Substantially advanced our atopic dermatitis program with the supplemental New Drug Application (sNDA) submission, and positive read-outs from the INTEGUMENT-PED and long-term trials Appointed industry veterans Todd Edwards and John W.

Arcutis Announces Third Quarter 2023 Financial Results and Provides Business Update

Down -50.77% in 4 Weeks, Here's Why You Should You Buy the Dip in Arcutis Biotherapeutics, Inc. (ARQT)

The heavy selling pressure might have exhausted for Arcutis Biotherapeutics, Inc. (ARQT) as it is technically in oversold territory now. In addition to this technical measure, strong agreement among Wall Street analysts in revising earnings estimates higher indicates that the stock is ripe for a trend reversal.

Arcutis Biotherapeutics, Inc. (ARQT) Loses -51.27% in 4 Weeks, Here's Why a Trend Reversal May be Around the Corner

Arcutis will host a conference call and webcast at 8:30 a.m. ET on 11/3/2023 to report its third quarter financial results and provide a business update.

Arcutis to Report Third Quarter 2023 Financial Results

Arcutis Biotherapeutics Inc shares slid more than 18% in pre-market trading on Friday after the early commercial-stage medical dermatology company announced its intention to raise $100 million in a public equity offering.  Arcutis said it plans to issue 32.5 million of its common shares at a public offering price of $2.50 per share, a notable discount to Thursday's closing price on the Nasdaq of $3.03.

Arcutis Biotherapeutics shares sink on $100M stock sale

New individual patient response data showed nearly all individuals (95%) treated with ZORYVE® (roflumilast) cream 0.3% had a measurable improvement in PASI

New Data Shows ZORYVE® (Roflumilast) Cream 0.3% Provided Measurable Improvement of Plaque Psoriasis in Nearly All Individuals in DERMIS Trials

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

Arcutis Announces Pricing of $100 Million Public Offering

Arcutis announced new data from its pivotal ARRECTOR Phase 3 trial of roflumilast foam 0.3% for treatment of adults/adolescents with scalp/body psoriasis.

Arcutis Presents Positive Patient-Reported Outcome Data from the Pivotal ARRECTOR Phase 3 Trial in Scalp and Body Psoriasis at European Academy of Dermatology and Venereology (EADV) Congress

Arcutis (ARQT) gains on receiving FDA approval for label expansion of Zoryve (roflumilast) cream 0.3% to treat patients in the age group of 6-11 years with plaque psoriasis.

Arcutis (ARQT) Up on FDA Nod for Zoryve Label Expansion

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 application (sNDA) to expand the indication of ZORYVE (roflumilast) cream 0.3% for the topical treatment of plaque psoriasis, including intertriginous areas, to children ages 6 to 11 years.

FDA Approves Arcutis' ZORYVE® (roflumilast) Cream 0.3% for Treatment of Psoriasis in Children Ages 6 to 11

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.

Arcutis Appoints L. Todd Edwards as Chief Commercial Officer

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.

New Campaign from Arcutis Aims to Educate, Raise Awareness, and Provide Encouragement for Those Living with Seborrheic Dermatitis

WESTLAKE VILLAGE, Calif., Sept. 19, 2023 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (NASDAQ: ARQT), an early commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced that the INTEGUMENT-PED pivotal Phase 3 trial of roflumilast cream 0.05%, in children ages 2 to 5 years with mild to moderate atopic dermatitis (AD) met its primary endpoint and all secondary endpoints. In the study, 25.4% of children treated with roflumilast cream 0.05% achieved IGA Success, defined as a validated Investigator Global Assessment – Atopic Dermatitis (vIGA-AD) score of ‘clear' or ‘almost clear' plus a 2-grade improvement from baseline at Week 4, compared to 10.7% treated with vehicle (P

Arcutis Announces Positive Results from INTEGUMENT-PED Pivotal Phase 3 Trial of Roflumilast Cream 0.05% for the Treatment of Atopic Dermatitis in Children Ages 2 to 5

Arcutis (ARQT) submits sNDA, seeking label expansion of Zoryve (roflumilast) cream 0.15% to treat patients with atopic dermatitis.

Arcutis (ARQT) Files sNDA for Zoryve in Atopic Dermatitis, Stock Up

WESTLAKE VILLAGE, Calif., Sept. 12, 2023 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for roflumilast cream 0.15% for the treatment of mild to moderate atopic dermatitis (AD) in adults and children ages 6 years and older.

Arcutis Submits Roflumilast Cream 0.15% Supplemental New Drug Application to the FDA for the Treatment of Atopic Dermatitis in Adults and Children Ages 6 Years and Older

Arcutis' cash position is the biggest concern for investors. The company is already seeing strong sales from Zoryve, a little more than a year after it was launched.

Why Shares of Arcutis Biotherapeutics Fell This Week

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

Arcutis Announces Positive Long-Term Results of Roflumilast Cream 0.15% Showing Durable and Improved Efficacy Over Time and Favorable Safety Profile in Treatment of Mild to Moderate Atopic Dermatitis (AD)

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