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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Arcutis Biotherapeutics, Inc. (ARQT) appears to have found support after losing some value lately, as indicated by the formation of a hammer chart. In addition to this technical chart pattern, strong agreement among Wall Street analysts in revising earnings estimates higher enhances the stock's potential for a turnaround in the near term.

Arcutis Biotherapeutics, Inc. (ARQT) Could Find a Support Soon, Here's Why You Should Buy the Stock Now

The average of price targets set by Wall Street analysts indicates a potential upside of 54.8% in Arcutis Biotherapeutics, Inc. (ARQT). While the effectiveness of this highly sought-after metric is questionable, the positive trend in earnings estimate revisions might translate into an upside in the stock.

Wall Street Analysts See a 54.78% Upside in Arcutis Biotherapeutics, Inc. (ARQT): Can the Stock Really Move This High?

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 Resources Officer (CHRO), effective immediately.

Arcutis Promotes Todd Tucker to Chief Human Resources Officer

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 application of roflumilast cream 0.05% based on daily Worst Itch Numeric Scale (WI-NRS) New data show 35.4% of children treated with roflumilast cream 0.05% achieved a validated Investigator Global Assessment – Atopic Dermatitis (vIGA-AD) score of ‘clear' or ‘almost clear' at Week 4, with significant improvements seen as early as Week 1 Results for roflumilast cream 0.05%, show consistent efficacy and favorable safety and tolerability profile from the INTEGUMENT-1 and INTEGUMENT-2 pivotal trials SAN DIEGO, March 10, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc.  (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today presented in a late-breaking clinical trial session at the American Academy of Dermatology (AAD) annual meeting (San Diego, CA, March 8 – 12) new data from its INTEGUMENT-PED pivotal Phase 3 study of investigational roflumilast cream 0.05% in children 2 to 5 years of age with mild to moderate atopic dermatitis. The study found that treatment with once-daily, steroid-free roflumilast cream 0.05% resulted in significant improvements in atopic dermatitis across multiple efficacy endpoints and all timepoints, including disease clearance as early as Week 1 and reduction in itch in the first 24 hours following application.

Arcutis Presents Late-Breaking Data From INTEGUMENT-PED Phase 3 Trial of Roflumilast Cream 0.05% in Atopic Dermatitis in Children Ages 2 to 5 at the American Academy of Dermatology Annual Meeting

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 immuno-dermatology, highlights new research that, for the first time, reveals the gene expression profile of seborrheic dermatitis.

New Research Reveals Genomic Profile of Seborrheic Dermatitis and Answers Key Questions on Immune Response and Skin Barrier Dysfunction

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 upon the exercise in full by the underwriters of their option to purchase additional shares of common stock at the public offering price, less underwriting discounts and commissions.

Arcutis Announces Closing of Public Offering of Common Stock and Full Exercise by Underwriters of Option to Purchase Additional Shares

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 dermatitis and investigational roflumilast foam in scalp and body psoriasis 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 five presentations at the 2024 American Academy of Dermatology (AAD) annual meeting, which will take place in San Diego, CA from March 8 - 12, 2024.

Arcutis Announces Acceptance of Late Breaking Abstract in Atopic Dermatitis Among Five New Topical Roflumilast Data Being Presented at the American Academy of Dermatology Annual Meeting

The consensus price target hints at a 58.9% upside potential for Arcutis Biotherapeutics, Inc. (ARQT). While empirical research shows that this sought-after metric is hardly effective, an upward trend in earnings estimate revisions could mean that the stock will witness an upside in the near term.

Wall Street Analysts See a 58.85% Upside in Arcutis Biotherapeutics, Inc. (ARQT): Can the Stock Really Move This High?

Here is how Arcutis Biotherapeutics, Inc. (ARQT) and Athira Pharma, Inc. (ATHA) have performed compared to their sector so far this year.

Is Arcutis Biotherapeutics (ARQT) Outperforming Other Medical Stocks This Year?

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 44th Annual Health Care Conference.

Arcutis to Present at the TD Cowen 44th Annual Health Care Conference

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 Announces Pricing of $150 Million Public Offering

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 its common stock.

Arcutis Announces Proposed Public Offering

Arcutis and Sato today announced that the companies have entered into a strategic collaboration and licensing agreement for topical roflumilast in Japan.

Arcutis and Sato Announce Strategic Collaboration and Licensing Agreement for Topical Roflumilast in Japan

Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT) Q4 2023 Earnings Conference Call February 27, 2024 8:30 AM ET

Arcutis Biotherapeutics, Inc. (ARQT) Q4 2023 Earnings Call Transcript

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 treatment of seborrheic dermatitis in adults and children down to age 9 in December 2023 and launched ZORYVE foam for seborrheic dermatitis in United States in late January 2024 July 7, 2024 PDUFA action date for roflumilast cream, 0.15%, for the treatment of atopic dermatitis in adults and children down to age 6 Strong financial position supports investment in plaque psoriasis and seborrheic dermatitis launches and continued development of pipeline 2023 R&D expenses decreased 39% to $111 million, compared to 2022, and the Company expects continued reductions in R&D expenses in 2024 as it focuses investments in on-going ZORYVE commercial launches WESTLAKE VILLAGE, Calif., Feb. 27, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today reported financial results for the quarter and year ended December 31, 2023, and provided a business update.

Arcutis Announces Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update

Arcutis today announced that it will report its fourth quarter and full year financial results and provide a business update on Tuesday, February 27, 2024.

Arcutis to Report Fourth Quarter and Full Year 2023 Financial Results

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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.

Arcutis to Present at the Guggenheim Healthcare Talks – 6th Annual Biotechnology Conference

The market may have been too quick to judge initially weak Zoryve sales data - while a risky stock to hold, strong sales and narrowing losses could drive significant share price upside in 2024.

Arcutis: Slow Sales Of Zoryve May Be Painting The Wrong Picture

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 immuno-dermatology, today announced that the Journal of American Academy of Dermatology (JAAD) published positive results from the pivotal Phase 3 STRATUM trial evaluating ZORYVE (roflumilast) foam, 0.3% as a once-daily steroid-free treatment for seborrheic dermatitis.

Journal of the American Academy of Dermatology Publishes ZORYVE (roflumilast) Foam, 0.3% Results for Seborrheic Dermatitis from Pivotal Phase 3 Trial

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 WESTLAKE VILLAGE, Calif., Jan. 22, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc.  (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced the launch of ZORYVE ® (roflumilast) topical foam, 0.3%, in the United States for the treatment of seborrheic dermatitis in individuals 9 years of age and older.

ZORYVE® (roflumilast) Topical Foam, 0.3%, for the Treatment of Seborrheic Dermatitis Launches in the United States

Arcutis Biotherapeutics, Inc. (ARQT) might move higher on growing optimism about its earnings prospects, which is reflected by its upgrade to a Zacks Rank #1 (Strong Buy).

Arcutis Biotherapeutics, Inc. (ARQT) Moves to Strong Buy: Rationale Behind the Upgrade

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 VILLAGE, Calif., Jan. 14, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc.  (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced a new subgroup analysis highlighting that adults and adolescents with seborrheic dermatitis who are contraindicated, intolerant, or unresponsive to topical steroids were 3.5 times more likely to achieve IGA Success with ZORYVE® (roflumilast) topical foam, 0.3%, compared to vehicle (78.8% ZORYVE foam; 48.3% vehicle; p

ZORYVE® (Roflumilast) Topical Foam, 0.3% Clears Seborrheic Dermatitis in Individuals Who Previously Reported an Inadequate Response to Topical Steroids

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.  (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced new individual patient response data showing the vast majority of individuals (91.5%) treated with investigational roflumilast cream 0.15% had a measurable improvement in Eczema Area and Severity Index (EASI) in 4 weeks.

Majority of Individuals with Atopic Dermatitis Improved with Arcutis' Roflumilast Cream 0.15% According to New Data from Phase 3 Program

ADMA Biologics

ADMA and ARQT made it to the Zacks Rank #1 (Strong Buy) momentum stocks list on January 11, 2024.

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