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ARQT 资讯
ARQT 事件
Oruka Therapeutics Appoints Todd Edwards as Chief Commercial Officer
Oruka Therapeutics (ORKA) announced the appointment of Todd Edwards as chief commercial officer, effective August 24. Edwards joins Oruka from Arcutis Biotherapeutics (ARQT), where he served as executive VP and chief commercial officer.
Arcutis Canada Approved ZORYVE Cream for Pediatric Eczema
Arcutis Canada announced that Health Canada has approved ZORYVE cream 0.05% for the topical treatment of mild to moderate atopic dermatitis in pediatric patients 2 to 5 years of age. Health Canada's approval is supported by data from the pivotal Phase 3 INTEGUMENT-PED study, which met its primary and key secondary endpoints, demonstrating significant improvements in overall disease severity, with treatment benefits observed as early as Week 1. In the long-term extension study, ZORYVE cream 0.05% demonstrated a consistent safety profile through 56 weeks, supporting its use in the long-term management of mild to moderate atopic dermatitis. "This approval marks an important milestone for Arcutis and for young children living with atopic dermatitis in Canada," said Jamie Lewis, vice president and general manager, Arcutis Canada. "The approval of ZORYVE cream 0.05% expands the ZORYVE portfolio to include children as young as two years old with a formulation purposefully developed to meet the unique needs of younger children. This milestone reinforces our commitment to addressing unmet needs in medical dermatology and advancing targeted therapies for people living with inflammatory skin diseases at every stage of life. We are proud to provide healthcare professionals with innovative treatment options that can make a meaningful difference for patients and their families."
Company Raises 2026 Net Product Sales Guidance to $525M-$540M
Consensus $500.09M. The company said, "The Company raised net product sales guidance for the full year 2026 from $480 million-$495 million to $525 million-$540 million."
Arcutis Appoints Christopher Peetz to Board of Directors
Arcutis Biotherapeutics (ARQT) announced that Christopher Peetz has been appointed to the Arcutis board of directors effective July 15. Peetz currently serves as a co-founder and chief executive officer of Mirum Pharmaceuticals (MIRM).
Arcutis Biotherapeutics' Zoryve Application Accepted by FDA
Arcutis Biotherapeutics announced that the FDA has accepted its supplemental new drug application, or sNDA, for Zoryve cream 0.05% to expand the indication for the topical treatment of mild to moderate atopic dermatitis to include infants aged 3 to 24 months. The FDA has set a PDUFA target action date of February 23, 2027.
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