Arcutis Biotherapeutics, Inc. Stock Price, News & Analysis

Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) announced the appointments of Eric McIntyre as Head of Investor Relations and Amanda Sheldon as Head of Corporate Communications. McIntyre brings 15 years of experience in biopharmaceuticals, having worked at Amgen, while Sheldon has over 20 years in healthcare communications. Their roles will support Arcutis' growth phase, including the anticipated New Drug Application for its lead product, topical roflumilast, aimed at various dermatological conditions. The company expects significant developments in its product pipeline in the coming months.

Arcutis Biotherapeutics (Nasdaq: ARQT) has introduced a new method called PASI-high discrimination (PASI-HD) to better assess the severity of mild-to-moderate plaque psoriasis. The updated approach aims to enhance clinical trials evaluating new topical treatments by providing more precise measurements than the existing PASI scale. The detailed methodology is published in Dermatology and Therapy. The new scale addresses the shortcomings of the PASI, particularly for patients with less than 10% skin affected, thus improving tracking of treatment effects.

Arcutis Biotherapeutics (Nasdaq: ARQT) has enrolled the first patient in its pivotal Phase 3 trial for topical roflumilast foam, aimed at treating seborrheic dermatitis, affecting over 10 million individuals in the U.S. This once-daily formulation seeks to address a significant unmet need in a condition without a new topical treatment in decades. Topline data is expected in Q2 or Q3 2022. The study will assess the foam's safety and efficacy, with a primary endpoint of achieving clear or almost clear skin at eight weeks.

Arcutis Biotherapeutics (Nasdaq: ARQT) has terminated its Phase 2a clinical trial of ARQ-252 for vitiligo due to formulation-related issues that hindered drug delivery, as indicated by a previous Phase 2b study in chronic hand eczema that did not meet its primary endpoint. Despite this setback, the company is reformulating ARQ-252 to enhance efficacy. The drug has shown promise in other inflammatory conditions, and no safety concerns have been reported. Arcutis aims to re-enter clinical trials with the improved formulation soon.

Arcutis Biotherapeutics (Nasdaq: ARQT) announced the appointment of Greg Sukay as Vice President, Manufacturing and Process Technologies. Sukay, with over 25 years of biopharmaceutical experience, will oversee external manufacturing and process development for Arcutis' medical dermatology programs. The company is progressing towards the anticipated launch of topical roflumilast, aimed at treating chronic skin conditions like psoriasis and dermatitis. This strategic hire is expected to enhance Arcutis' capacity to deliver innovative therapies.

Arcutis Biotherapeutics (Nasdaq: ARQT) recently appointed Sue-Jean Lin to its Board of Directors as of June 9, 2021, following Jonathan Silverstein's resignation for personal reasons. Lin brings 30 years of experience in digital technology and life sciences, which aligns with Arcutis's goals in advancing its pipeline, particularly the topical roflumilast for various skin conditions. Arcutis aims to address unmet needs in dermatology, enhancing its leadership as it prepares for potential commercial launches.

Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) announced the appointment of Rajvir Madan as Chief Digital and Information Officer. Madan, with over 20 years in digital transformation in healthcare, will lead Arcutis' digital and analytics initiatives as the company approaches its first potential commercial launch. The company aims to enhance its capabilities to address unmet needs in dermatological diseases, including plaque psoriasis and atopic dermatitis, through innovative therapies. Arcutis is advancing its pipeline of four novel drug candidates in immuno-dermatology.

Arcutis Biotherapeutics (Nasdaq: ARQT) announced promising results from Phase 3 trials (DERMIS-1 and DERMIS-2) for roflumilast cream, a topical treatment for chronic plaque psoriasis. The trials demonstrated significant efficacy, with 42.4% and 37.5% of patients achieving Investigator Global Assessment (IGA) success compared to 6.1% and 6.9% in the control group, both statistically significant (P<0.001). Key secondary endpoints showed similar improvements. Safety profiles were comparable to the vehicle, with no serious adverse events reported. These findings support roflumilast as a potential innovative therapy in dermatology.

Arcutis Biotherapeutics (ARQT) reported Q1 2021 financial results, highlighting a strong cash position of over $446 million, ensuring funding into 2023. A New Drug Application (NDA) for topical roflumilast cream, a treatment for plaque psoriasis, is expected in H2 2021, following positive Phase 3 results. However, the Phase 1/2b study of ARQ-252 for chronic hand eczema did not meet its primary endpoint. R&D expenses were $21.6 million, down from $25.2 million a year earlier, while G&A expenses rose to $14.5 million due to increased headcount and one-time charges.