Core Viewpoint - Arcutis Biotherapeutics has submitted a supplemental New Drug Application (sNDA) to the FDA to expand the indication of ZORYVE (roflumilast) cream 0.3% for treating plaque psoriasis in children as young as 2 years old, potentially making it the first topical PDE4 inhibitor for this age group [1][7]. Group 1: Product Information - ZORYVE cream is a once-daily, steroid-free, non-greasy formulation that avoids sensitizing excipients and irritants, making it suitable for sensitive skin areas [3][7]. - The cream is currently approved for plaque psoriasis in patients aged 6 and older, and the sNDA is supported by data from a 4-week study in children aged 2 to 5 years, demonstrating favorable long-term safety and efficacy [4][8]. Group 2: Market Need - There is a significant unmet need for effective, non-steroidal treatment options for plaque psoriasis in children under 6, particularly for those with sensitive skin [2][5]. - Plaque psoriasis is the most common form of psoriasis in young children, often affecting sensitive areas like the face and intertriginous regions, which complicates long-term management [2][5]. Group 3: Company Commitment - Arcutis aims to establish ZORYVE as a foundational therapy for young children with inflammatory skin diseases, addressing historical gaps in treatment options studied for pediatric patients [4][14]. - The company is dedicated to conducting trials of ZORYVE in pediatric patients across various inflammatory skin diseases to enhance treatment availability [4][14].

Core Insights - Oruka Therapeutics has initiated the EVERLAST-A Phase 2a trial for ORKA-001, with data expected in the second half of 2026 [1][6] - The company aims to establish ORKA-001 as a leading treatment for chronic skin diseases, particularly plaque psoriasis, by demonstrating its unique dosing interval and efficacy [2][14] Company Updates - ORKA-001 is a novel half-life extended IL-23p19 monoclonal antibody, while ORKA-002 is a half-life extended IL-17A/F monoclonal antibody currently in Phase 1 trials [3][4] - The EVERLAST-A trial is designed to enroll approximately 80 patients with moderate-to-severe plaque psoriasis, focusing on achieving complete skin clearance [6] - The company has completed dosing for all 24 subjects in the Phase 1 trial of ORKA-001, with results to be presented at the EADV Congress in September 2025 [6] Financial Performance - As of June 30, 2025, Oruka had cash, cash equivalents, and marketable securities totaling $351.5 million, with a net cash usage of $23.1 million in Q2 2025 [9] - Research and Development (R&D) expenses increased to $24.1 million in Q2 2025 from $18.7 million in Q2 2024, primarily due to employee compensation [10] - General and Administrative (G&A) expenses rose to $4.3 million in Q2 2025 from $2.8 million in Q2 2024, reflecting growth in operations and public company costs [11] Pipeline Developments - ORKA-002's Phase 1 trial is ongoing, with interim data expected around the end of 2025 and a Phase 2 trial planned for the first half of 2026 [4] - The company is also advancing ORKA-021, a sequential combination regimen of ORKA-002 and ORKA-001, aimed at providing rapid and deep responses in psoriatic disease treatment [7][8]

Core Insights - Johnson & Johnson has submitted a New Drug Application (NDA) for icotrokinra, a first-in-class oral peptide targeting the IL-23 receptor, aimed at treating moderate-to-severe plaque psoriasis in patients aged 12 and older [1][2][6] - The NDA is supported by data from four pivotal Phase 3 studies, demonstrating significant skin clearance and a favorable safety profile, with icotrokinra showing superiority over deucravacitinib [1][2][4] - The treatment offers a once-daily pill option, which may shift the treatment paradigm for plaque psoriasis patients [1][2][5] Phase 3 Studies Overview - The ICONIC clinical development program includes studies such as ICONIC-LEAD, ICONIC-TOTAL, ICONIC-ADVANCE 1, and ICONIC-ADVANCE 2, all of which met primary and co-primary endpoints [1][4][6] - ICONIC-LEAD involved 684 participants, showing significant improvements in skin conditions compared to placebo [3][4] - ICONIC-ASCEND is the first head-to-head study comparing icotrokinra with ustekinumab, an injectable biologic, marking a significant advancement in psoriasis research [2][4] Efficacy and Safety Data - Results from the ICONIC-ADVANCE studies confirmed icotrokinra's efficacy, achieving co-primary endpoints of Investigator's Global Assessment (IGA) score of 0/1 and Psoriasis Area and Severity Index (PASI) 90 [2][3][4] - Safety data pooled from all studies indicated a similar proportion of adverse events between icotrokinra (49.1%) and placebo (51.9%), with no new safety signals identified [1][2][4] Patient Impact and Market Potential - Approximately 8 million Americans and over 125 million people globally suffer from plaque psoriasis, with nearly one-quarter experiencing moderate-to-severe cases [5][6] - The introduction of icotrokinra could significantly improve the quality of life for patients, particularly those with difficult-to-treat areas such as the scalp and genitals [2][5][6] - The innovative oral formulation may appeal to patients seeking more convenient treatment options compared to traditional injectables [1][2][5]