Atopic dermatitis
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EADV 2025: Galderma Reinforces Leadership in Dermatology With Latest Advances in Sensitive Skin and Itch
Businesswire· 2025-09-11 05:00
Core Insights - Galderma, a leader in the dermatology category, will present updates from its portfolio at the 34th European Academy of Dermatology and Venereology (EADV) congress in Paris from September 17-20, 2025 [1] - The company is committed to addressing various skin conditions and will showcase 12 abstracts, including data on sensitive skin, prurigo nodularis, and atopic dermatitis [1] Company Focus - Galderma emphasizes its dedication to dermatology by participating in significant industry events like the EADV congress [1] - The presentation of 12 abstracts indicates a robust research and development pipeline aimed at enhancing treatment options for skin conditions [1]
Apogee Therapeutics (APGE) Earnings Call Presentation
2025-07-04 07:41
Pipeline and Clinical Development - Apogee plans to transform the standard-of-care for I&I diseases with novel antibodies and combination approaches [6] - APG777 Phase 2 Part A is fully enrolled, with a readout expected in mid-2025, potentially demonstrating best-in-class efficacy [8, 33] - APG279, a combination of APG777 and APG990, is expected to initiate a Phase 1b trial against DUPIXENT in 2025, with a readout expected in 2H 2026 [6, 19] - APG777+APG333 clinical planning is underway for asthma and COPD [19] - Apogee has 7 clinical trial readouts expected over the next 2 years [105] Financial Position - Apogee has $681 million in total cash, providing an expected runway into Q1 2028 [7, 105] Market Opportunity - The atopic dermatitis (AD) market is projected to be a future $50B+ market [7, 17, 25, 90] - Mature I&I markets have consistently achieved high biologics penetration, approximately 25-60% after 15-20 years [9] - In 2024, the worldwide market size for IBD was $24B, RA was $24B, PsO was $29B [10] APG777 Potential - APG777 has the potential for annual dosing due to its optimized PK profile and 77-day half-life [8, 30, 31] - APG777 Phase 2 induction exposures are designed to exceed EBGLYSS for potentially greater efficacy [35] - APG777 could substantially decrease annual injections for patients, potentially requiring only 2-4 injections compared to EBGLYSS (13-26) and DUPIXENT (26) [45, 46]
Why Is Nektar Therapeutics Stock Trading Higher On Wednesday?
Benzinga· 2025-06-25 17:42
Core Insights - Nektar Therapeutics released statistically significant data from the 16-week induction period of the Phase 2b REZOLVE-AD study for the investigational drug rezpegaldesleukin, achieving its primary endpoint in improving the Eczema Area and Severity Score (EASI) compared to placebo [1][2]. Group 1: Study Results - All three dose arms of rezpegaldesleukin showed statistical significance at week 16 for key secondary endpoints, including EASI-75, EASI-50, and Body Surface Area (BSA) score improvements [2]. - Patients treated with rezpegaldesleukin experienced a 53% to 61% improvement in symptoms, while the placebo group showed a 31% improvement [3]. Group 2: Comparative Analysis - The efficacy of rezpegaldesleukin appears comparable to the OX40 drug class but is numerically lower than Dupixent in Phase IIb programs [3]. - High frequencies of injection site reactions (30% to 40%) for rezpegaldesleukin could pose a commercial liability compared to Dupixent, which has lower reaction rates [3]. Group 3: Future Outlook - If rezpegaldesleukin demonstrates a remittive effect, it may reduce injection site reactions, but further updates are needed, with maintenance data expected in early 2026 and off-treatment results in 2027 [4]. - The stock reaction, which saw a rise of approximately 135%, is viewed as a normalization event rather than a reflection of a differentiated asset, with shares trading around the company's current cash levels [5].
Arcutis Enrolls First Child in INTEGUMENT-INFANT Evaluating ZORYVE® (roflumilast) Cream 0.05% in Infants with Atopic Dermatitis
Globenewswire· 2025-06-10 12:00
Core Viewpoint - Arcutis Biotherapeutics has initiated a Phase 2 open-label study for ZORYVE (roflumilast) cream 0.05% in infants with atopic dermatitis, marking a significant step in addressing unmet needs in pediatric dermatology [1][2][3] Company Overview - Arcutis Biotherapeutics, Inc. is a commercial-stage biopharmaceutical company focused on innovations in immuno-dermatology, with a commitment to addressing urgent needs in dermatological diseases [15] Study Details - The INTEGUMENT-INFANT study will enroll approximately 35 infants aged 3 months to less than 2 years with mild to moderate atopic dermatitis, evaluating the safety and tolerability of roflumilast cream applied once daily over four weeks [3][9] - This study builds on previous successful results from the ARQ-151-105 (MUSE) study, which also evaluated roflumilast cream in infants [3] Atopic Dermatitis (AD) Insights - Atopic dermatitis is a chronic condition affecting approximately 9.6 million children in the United States, with up to 60% of cases developing symptoms within the first year of life [5][9] - The condition significantly impacts families by disrupting sleep and increasing the risk of skin infections, highlighting the need for effective treatments [2] ZORYVE Product Information - ZORYVE is the first and only branded topical therapy for atopic dermatitis, seborrheic dermatitis, and plaque psoriasis, representing a next-generation topical PDE4 inhibitor [6][7] - ZORYVE cream 0.15% is currently under FDA review for the treatment of mild to moderate atopic dermatitis in children aged 2 to 5 years, with a target action date of October 13, 2025 [8]