Arcutis Biotherapeutics(ARQT)
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Arcutis Submits Supplemental New Drug Application for ZORYVE® (roflumilast) Foam to the FDA for the Treatment of Scalp and Body Psoriasis in Adults and Adolescents Ages 12 and Over
Newsfilter· 2024-07-23 12:00
Approximately 40% of the 9 million individuals in the United States with plaque psoriasis experience involvement of the scalpOnce-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 profile WESTLAKE VILLAGE, Calif., July 23, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT), a commer ...
Arcutis to Host ZORYVE® (Roflumilast) Cream 0.15% FDA Approval Call With KOL
Newsfilter· 2024-07-22 12:00
WESTLAKE VILLAGE, Calif., July 22, 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 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 th ...
Is Arcutis Biotherapeutics (ARQT) Stock Outpacing Its Medical Peers This Year?
ZACKS· 2024-07-19 14:41
Investors interested in Medical stocks should always be looking to find the best-performing companies in the group. Has Arcutis Biotherapeutics, Inc. (ARQT) been one of those stocks this year? By taking a look at the stock's year-to-date performance in comparison to its Medical peers, we might be able to answer that question.Arcutis Biotherapeutics, Inc. is one of 1025 individual stocks in the Medical sector. Collectively, these companies sit at #4 in the Zacks Sector Rank. The Zacks Sector Rank gauges the ...
Arcutis (ARQT) Stock Rises 31% in the Past Month: Here's Why
ZACKS· 2024-07-17 14:57
Arcutis Biotherapeutics (ARQT) rallied 30.9% in the past month after the FDA approved the supplemental new drug application (sNDA) for its marketed product, Zoryve (roflumilast) cream 0.15%, to treat mild to moderate atopic dermatitis (AD) in adult and pediatric patients aged six years and older.AD, also known as eczema, is a chronic skin disease characterized by itchy and inflamed skin, primarily common in children. Per Arcutis, 9.6 million children and 16.5 million adults in the United States are affected ...
FDA Approves Arcutis' ZORYVE® (roflumilast) Cream 0.15% for the Treatment of Atopic Dermatitis in Adults and Children Down to 6 Years of Age
Newsfilter· 2024-07-09 20:53
ZORYVE cream provides rapid relief, with efficacy, safety, and tolerability demonstrated up to 56 weeks of treatmentZORYVE cream rapidly and significantly reduces itch, the most bothersome symptom of atopic dermatitis (AD)Once-daily cream is for use anywhere on the body for any durationAD is the most common type of eczema, affecting approximately 9.6 million children and 16.5 million adults in the United StatesThird FDA approval for Company in two yearsCommercial product expected to be available by the end ...
FDA Approves Arcutis' ZORYVE® (roflumilast) Cream 0.15% for the Treatment of Atopic Dermatitis in Adults and Children Down to 6 Years of Age
GlobeNewswire News Room· 2024-07-09 20:53
ZORYVE cream provides rapid relief, with efficacy, safety, and tolerability demonstrated up to 56 weeks of treatmentZORYVE cream rapidly and significantly reduces itch, the most bothersome symptom of atopic dermatitis (AD)Once-daily cream is for use anywhere on the body for any durationAD is the most common type of eczema, affecting approximately 9.6 million children and 16.5 million adults in the United StatesThird FDA approval for Company in two yearsCommercial product expected to be available by the end ...
Top 5 Small-Cap Biotechnology Stocks for a Stable Portfolio
ZACKS· 2024-06-21 13:25
Industry Overview - The biotechnology industry faced challenges in the first quarter of 2024 after a decent performance in 2023, with many companies relying on external funding due to insufficient revenue generation [1] - The high interest rate environment, currently between 5.25-5.5%, has negatively impacted the industry, as the Federal Reserve has not reduced rates despite expectations for a cut [1] - A low interest rate environment is anticipated to improve margins for biotech companies, which require significant capital for clinical studies before obtaining FDA approval [2] Market Outlook - Fed Chairman Jerome Powell indicated a potential 25 basis points cut in the Fed fund rate in 2024, with a full 1% rate cut expected by the end of 2025, bringing the terminal rate to 4.1% [2] - The biotech industry is expected to recover in the second half of 2024, driven by collaborations and mergers and acquisitions as companies seek to enhance their product portfolios [2] Industry Ranking - The Zacks-defined Biomedical and Genetics Industry is currently ranked in the top 34% of industries, specifically at number 85 out of 249, indicating an expectation to outperform the market in the next three to six months [3] Company Highlights - **Arcutis Biotherapeutics Inc. (ARQT)**: Focused on immune-mediated dermatological diseases, with an expected revenue growth rate of over 100% and earnings growth of 57.7% for the current year [5] - **Bicycle Therapeutics plc (BCYC)**: Developing innovative medicines for underserved diseases, with expected revenue and earnings growth rates of 55.4% and 12.6%, respectively [6] - **Castle Biosciences Inc. (CSTL)**: Provides genomic information for dermatological cancers, with expected revenue and earnings growth rates of 18.7% and 20.6% [7] - **Prime Medicine Inc. (PRME)**: Focuses on genetic therapies using gene editing technology, with expected revenue growth of over 100% and earnings growth of 19.2% [8] - **Lexicon Pharmaceuticals Inc. (LXRX)**: Specializes in gene function discovery for drug development, with expected revenue growth of over 100% and earnings growth of 11.4% [8]
Has Arcutis Biotherapeutics (ARQT) Outpaced Other Medical Stocks This Year?
ZACKS· 2024-06-17 14:46
For those looking to find strong Medical stocks, it is prudent to search for companies in the group that are outperforming their peers. Has Arcutis Biotherapeutics, Inc. (ARQT) been one of those stocks this year? A quick glance at the company's year-to-date performance in comparison to the rest of the Medical sector should help us answer this question.Arcutis Biotherapeutics, Inc. is one of 1043 individual stocks in the Medical sector. Collectively, these companies sit at #7 in the Zacks Sector Rank. The Za ...
Wall Street Analysts Think Arcutis Biotherapeutics (ARQT) Could Surge 99.89%: Read This Before Placing a Bet
ZACKS· 2024-06-14 14:55
Shares of Arcutis Biotherapeutics, Inc. (ARQT) have gained 2.4% over the past four weeks to close the last trading session at $9.34, but there could still be a solid upside left in the stock if short-term price targets of Wall Street analysts are any indication. Going by the price targets, the mean estimate of $18.67 indicates a potential upside of 99.9%.The mean estimate comprises six short-term price targets with a standard deviation of $4.80. While the lowest estimate of $11 indicates a 17.8% increase fr ...
Arcutis Announces New Long-Term Data of Roflumilast Cream 0.15% for the Treatment of Mild to Moderate Atopic Dermatitis (AD) in Adults and Children Down to Age Six Presented at Revolutionizing Alopecia Areata, Vitiligo, and Eczema Conference
Newsfilter· 2024-06-10 18:30
Core Insights - Investigational roflumilast cream 0.15% demonstrated sustained improvements in atopic dermatitis (AD) symptoms over 56 weeks, including a 66.2% achievement rate of 75% improvement in Eczema Area and Severity Index (EASI-75) among participants [1][4] - The cream was well tolerated with no new safety signals observed during the study, reinforcing its safety profile [1][5] - The study supports the potential of roflumilast cream as a long-term, steroid-free treatment option for AD, emphasizing proactive disease management [3][6] Efficacy and Safety - 66.2% of participants treated with roflumilast cream achieved EASI-75 at Week 56, with 56.6% of those continuing from the initial trial and 53.8% switching from vehicle achieving validated Investigator Global Assessment-Atopic Dermatitis (vIGA-AD) success [1][4] - The median duration of disease control for participants switching to proactive twice-weekly application was 281 days, with 57.7% maintaining control through the study [2][4] - The overall incidence of adverse events was low, with most being mild to moderate, and only 3.0% of participants discontinued due to adverse events [5] Study Design and Objectives - The INTEGUMENT-OLE study was a Phase 3, multicenter, open-label extension evaluating the long-term safety of roflumilast cream in adults and children aged 6 years and older with AD [7][8] - The primary objective was to assess long-term safety, while secondary endpoints included vIGA-AD scores and EASI scores over time [8] Product Information - Roflumilast cream is a topical phosphodiesterase-4 (PDE4) inhibitor, currently under FDA review for the treatment of AD, with a target action date of July 7, 2024 [10] - The cream is formulated to be non-greasy and free from known allergens that may compromise skin barrier integrity, offering a steroid-free option for patients [6][10] Market Context - Atopic dermatitis affects approximately 9.6 million children and 16.5 million adults in the United States, highlighting the significant need for effective long-term treatments [9] - The results from the study may shift treatment paradigms from reactive management of flares to proactive long-term disease control [3][6]