Arcutis Biotherapeutics(ARQT)
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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]
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
GlobeNewswire News Room· 2024-06-10 18:30
Investigational roflumilast cream 0.15% showed continued improvements in the signs and symptoms of AD, including itch, through 56 weeks of treatment66.2% of participants treated with once-daily roflumilast cream 0.15% in both the 4-week parent study and the 52-week open label extension achieved a 75% improvement in Eczema Area and Severity Index (EASI-75) at Week 56For participants who achieved disease clearance and switched to proactive twice weekly application of roflumilast cream, the median duration of ...
Arcutis Biotherapeutics Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
Newsfilter· 2024-06-05 20:00
WESTLAKE VILLAGE, Calif., June 05, 2024 (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 57,500 restricted stock units of Arcutis' common stock to six 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, wit ...
Wall Street Analysts Believe Arcutis Biotherapeutics (ARQT) Could Rally 101.09%: Here's is How to Trade
zacks.com· 2024-05-20 14:56
Core Viewpoint - Arcutis Biotherapeutics, Inc. (ARQT) shows significant upside potential with a mean price target of $18.50, indicating a 101.1% increase from the current price of $9.20 [1] Price Targets and Analyst Consensus - The mean estimate consists of six short-term price targets with a standard deviation of $4.81, suggesting variability in analyst predictions [1] - The lowest estimate of $11 indicates a 19.6% increase, while the highest estimate suggests a potential surge of 182.6% to $26 [1] - Analysts' price targets can often mislead investors, as they may set overly optimistic targets due to business incentives [3][4] Earnings Estimates and Market Sentiment - Analysts are optimistic about ARQT's earnings prospects, with a 17.1% increase in the Zacks Consensus Estimate over the past month [5] - There is a strong correlation between earnings estimate revisions and near-term stock price movements, supporting the potential for upside [5] - ARQT holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimates [5]
Arcutis Biotherapeutics(ARQT) - 2024 Q1 - Earnings Call Transcript
2024-05-14 23:47
Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT) Q1 2024 Earnings Conference Call May 14, 2024 4:30 PM ET Company Participants Latha Vairavan - Vice President, Finance and Head of Investor Relations Frank Watanabe - President and Chief Executive Officer Todd Edwards - Chief Commercial Officer Patrick Burnett - Chief Medical Officer David Topper - Chief Financial Officer Conference Call Participants Serge Belanger - Needham Seamus Fernandez - Guggenheim Securities Vikram Purohit - Morgan Stanley Tyler Van Buren - ...
Arcutis Biotherapeutics(ARQT) - 2024 Q1 - Quarterly Report
2024-05-14 20:08
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form10-Q 91361 (Zip Code) (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For transition period from to Commission File Number: 001-39186 ARCUTIS BIOTHERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware (State or Other ...