Arcutis Biotherapeutics, Inc. - ARQT STOCK NEWS

On September 2, 2021, Arcutis Biotherapeutics (Nasdaq: ARQT) appointed Keith R. Leonard Jr. to its Board of Directors, succeeding Ricky Sun, Ph.D., who stepped down for personal reasons. Leonard brings over 25 years of leadership experience in the biopharmaceutical sector, having previously served as CEO of two public companies and as a board member for several others. The management expresses confidence in Leonard's ability to support the company's goals, particularly as it prepares for the potential commercial launch of topical roflumilast, targeting various dermatological conditions.

Arcutis Biotherapeutics (Nasdaq: ARQT) has initiated its Phase 3 clinical trial for topical roflumilast foam (ARQ-154), targeting scalp and body psoriasis, which affects over 8 million U.S. patients. The ARRECTOR study will enroll approximately 420 subjects aged 12 and older, assessing safety and efficacy. Key endpoints include Scalp-Investigator’s Global Assessment success after 8 weeks. Previous trials have indicated roflumilast's effectiveness and safety. The company aims for FDA submission following positive trial results, addressing an unmet need in dermatological treatment.

Arcutis Biotherapeutics (Nasdaq: ARQT) has appointed Bruce Binkowitz as Vice President of Biometrics, bringing over 30 years of drug development experience. He will oversee biometrics activities supporting late-stage clinical programs and regulatory submissions for topical roflumilast in treating psoriasis, atopic dermatitis, and seborrheic dermatitis. The company anticipates its first New Drug Application submission by late 2021, as well as three Phase 3 clinical data readouts in the next 18 months. Arcutis aims to innovate treatments for serious skin disorders.

Arcutis Biotherapeutics (ARQT) has reported a net loss of $42 million for Q2 2021, with total cash and equivalents at $410.9 million, supporting operations into 2023. The company is preparing to submit a New Drug Application for topical roflumilast cream targeting plaque psoriasis by late Q3 or early Q4 2021. Multiple Phase 3 trials for roflumilast formulations are ongoing, with topline data anticipated in 2022. However, there were setbacks with ARQ-252 in chronic hand eczema and vitiligo, leading to its termination.

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.