Core Viewpoint - Arcutis Biotherapeutics announced the FDA's acceptance of a supplemental New Drug Application for ZORYVE® cream 0.3%, aiming to expand its indication for treating plaque psoriasis in children aged 2 to 5 years, with a target action date set for June 29, 2026 [1][6]. Company Overview - Arcutis Biotherapeutics is a commercial-stage biopharmaceutical company focused on innovations in immuno-dermatology, with a commitment to addressing the needs of individuals with immune-mediated skin diseases [7]. - The company has developed a portfolio of advanced targeted topicals approved for treating major inflammatory skin diseases [7]. Product Information - ZORYVE cream 0.3% is a topical phosphodiesterase-4 (PDE4) inhibitor, currently approved for plaque psoriasis in adults and children aged 6 and older [1][8]. - If approved for younger children, ZORYVE would be the first and only topical PDE4 inhibitor indicated for this age group, providing a steroid-free treatment option [2][6]. Clinical Data - The supplemental New Drug Application is supported by data from a 4-week Maximal Usage Systemic Exposure (MUSE) study and a long-term open-label study, demonstrating favorable safety and tolerability in children aged 2 to 5 years [2][3]. Market Context - Plaque psoriasis affects nearly 9 million people in the U.S., with treatment challenges particularly pronounced in young children due to the sensitive areas affected [3]. - ZORYVE cream is recognized as the number one prescribed branded topical therapy for atopic dermatitis, seborrheic dermatitis, and plaque psoriasis [4]. Recognition and Awards - ZORYVE has received multiple awards, including the "2025 Best of Beauty Breakthrough Award" from Allure and the National Psoriasis Foundation's Seal of Recognition, highlighting its clinical impact and industry recognition [5].

Core Viewpoint - Arcutis Biotherapeutics has agreed to a joint stipulation to stay ongoing patent litigation with Padagis, preserving its intellectual property rights and the Hatch-Waxman stay for its product ZORYVE [1][2][3] Group 1: Patent Litigation and Agreement - Padagis has requested a stay in the patent litigation against Arcutis, which the company has agreed to, leading to the vacating of all trial dates [1] - The joint stipulation requires Padagis to inform Arcutis of any FDA correspondence regarding their ANDA for a generic version of ZORYVE [2] - The Hatch-Waxman stay of regulatory approval will be extended by one day for each day the litigation is stayed, ensuring Arcutis retains its benefits under the Act [2] Group 2: Product Information and Market Position - ZORYVE cream 0.3% is indicated for the treatment of plaque psoriasis in patients aged 6 and older, with patent protection extending until at least 2037 [3][5] - The company aims to enhance the adoption of ZORYVE as a safe alternative to steroids for treating inflammatory dermatoses [3] - Arcutis has a growing portfolio of FDA-approved products and a robust pipeline targeting various inflammatory dermatological conditions [4]