Data demonstrated favorable safety and local tolerability of ZORYVE® (roflumilast) cream 0.15% in adults and children with atopic dermatitis (AD) with prior inadequate response, intolerance, and contraindications to topical treatments New patient reported outcome data for investigational ZORYVE® (roflumilast) foam 0.3% demonstrated favorable efficacy, safety, and local tolerability data in scalp and body psoriasis In the United States, AD affects approximately 26 million adults and children and psoriasis affects approximately 9 million adults and children, with more than half experiencing involvement of the scalp WESTLAKE VILLAGE, Calif. and ORLANDO, Fla.
From a technical perspective, Arcutis Biotherapeutics, Inc. (ARQT) is looking like an interesting pick, as it just reached a key level of support. ARQT recently overtook the 50-day moving average, and this suggests a short-term bullish trend.
Data from phase 1b study, using ARQ-255 for the treatment of patients with alopecia areata, expected in the 1st half of 2025. The global alopecia areata market size is expected to be worth $6.92 billion by 2034. Full-year 2024 net product revenue of ZORYVE was $166.5 million, which was a year-over-year growth rate of 471%.
Arcutis Biotherapeutics is a strong buy due to ZORYVE's rapid sales growth and potential for positive earnings within 12 months. ZORYVE, a non-steroidal cream for psoriasis and dermatitis, saw Q4 sales of $69.4M, a 413% YoY increase, beating sales estimates by $10.8M. ZORYVE has maintained quarterly growth of >40% since Q1 2024. Remarkably only one additional quarter of such robust growth will bring sales to a pace needed to achieve profitability.
U.S. Food and Drug Administration (FDA) has set a Prescription Drug User Fee Act (PDUFA) target action date of October 13, 2025 Application supported by positive efficacy and safety data from pivotal Phase 3 trial, pivotal long-term extension study, and Phase 1 pharmacokinetic study If approved, ZORYVE cream 0.05% will be a new topical therapy option for approximately 1.8 million children aged 2 to 5 with atopic dermatitis (AD) in the United States WESTLAKE VILLAGE, Calif., Feb. 26, 2025 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced the FDA's acceptance of a supplemental New Drug Application (sNDA) for ZORYVE (roflumilast) cream 0.05%, a once-daily, next generation phosphodiesterase-4 (PDE4) inhibitor, for the topical treatment of mild to moderate AD in children 2 to 5 years old.
Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT ) Q4 2024 Earnings Conference Call February 25, 2025 4:30 PM ET Company Participants Latha Vairavan - Vice President, Finance & Investor Relations Frank Watanabe - President & Chief Executive Officer Todd Edwards - Chief Commercial Officer Patrick Burnett - Chief Medical Officer David Topper - Chief Financial Officer Conference Call Participants Vikram Purohit - Morgan Stanley Tyler Van Buren - TD Cowen Seamus Fernandez - Guggenheim Securities Serge Belanger - Needham & Co. Uy Ear - Mizuho Kambiz Yazdi - Jefferies Douglas Tsao - H.C. Wainwright Operator Good day and welcome to Arcutis Biotherapeutics 2024 Fourth Quarter and Full Year Financial Results Conference Call.
Arcutis Biotherapeutics, Inc. (ARQT) came out with a quarterly loss of $0.09 per share versus the Zacks Consensus Estimate of a loss of $0.27. This compares to loss of $0.72 per share a year ago.
Arcutis Biotherapeutics (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.
Odell Beckham Jr. first noticed flakes throughout his iconic beard and hairline in his 20s; today, for the first time he is sharing his experience with ZORYVE® (roflumilast) topical foam, 0.3%, to help others learn more about this chronic inflammatory skin condition ZORYVE foam is a once-daily, steroid-free, topical for seborrheic dermatitis uniquely formulated for use anywhere on the body, including hair-bearing areas Seborrheic dermatitis impacts more than 10 million Americans and is the third most common skin condition affecting Blacks WESTLAKE VILLAGE, Calif. , Feb. 4, 2025 /PRNewswire/ -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced a partnership with the iconic professional football player, Odell Beckham Jr. ("OBJ"), to help raise awareness of seborrheic dermatitis ("seb derm") a common, chronic, recurrent inflammatory skin disease that can cause flaking, redness, itching, and discoloration of the skin.
Preliminary unaudited product revenue for the fourth quarter of 2024 is expected to be approximately $63 million, up approximately 366% vs. Q4 2023 and 41% vs.