Arcutis Biotherapeutics, Inc. Stock Price, News & Analysis

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.

Arcutis Biotherapeutics (Nasdaq: ARQT) is set to present data from pivotal Phase 3 studies, DERMIS-1 and DERMIS-2, evaluating the efficacy and safety of roflumilast cream for chronic plaque psoriasis at the EADV Spring Symposium on May 6-7, 2021. The research involved 881 subjects and focused on the drug's potential as a once-daily topical treatment. Chief Medical Officer Patrick Burnett expressed excitement over the opportunity to share findings at this respected dermatology forum, emphasizing the significance of the study led by renowned psoriasis expert, Dr. Mark Lebwohl.

Arcutis Biotherapeutics, a late-stage biopharmaceutical firm focused on dermatological treatments, will participate in the 2021 Truist Securities Life Sciences Summit. The virtual fireside chat is scheduled for May 5, 2021, at 1:00 p.m. ET. Investors can access the presentation via Arcutis' website under the 'Events & Presentations' section. The company is developing therapies for various immune-mediated skin diseases and aims to enhance treatment options for conditions such as plaque psoriasis. An archived replay of the webcast will be available for 30 days post-conference.

Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) presented new data on roflumilast foam for psoriasis treatment at the AAD Virtual Meeting on April 23-25, 2021. The Phase 2b study showed that roflumilast foam was well-tolerated and significantly improved scalp and body psoriasis as early as two weeks after treatment initiation. The foam achieved a primary endpoint success of 59.1% for scalp psoriasis by week eight, compared to 11.4% for the vehicle. Additional findings supported the foam's efficacy for seborrheic dermatitis and roflumilast cream for chronic plaque psoriasis, highlighting its potential as a new treatment option.

Arcutis Biotherapeutics (Nasdaq: ARQT) announces new data presentations on its topical roflumilast cream and foam for treating chronic plaque psoriasis, scalp psoriasis, and seborrheic dermatitis, during the American Academy of Dermatology Virtual Meeting Experience from April 23-25, 2021. Key highlights include results from a Phase 2b study of roflumilast foam and various sub-analyses of the cream. Chief Medical Officer Patrick Burnett emphasized the unmet needs in treatment options for these conditions. If approved by the FDA, these therapies could significantly improve patient care.

Arcutis Biotherapeutics (Nasdaq: ARQT) announced the initiation of a pivotal Phase 3 trial for its topical roflumilast cream (ARQ-151) targeting mild-to-moderate atopic dermatitis in children aged 2 to 5. With approximately 19 million affected in the U.S., the trial aims to assess safety, efficacy, and tolerability. Enrolling around 650 subjects, the study will measure primary and secondary endpoints, with topline data expected in the second half of 2022. If successful, roflumilast cream may provide a new treatment option in a field with limited alternatives.

Arcutis Biotherapeutics (Nasdaq: ARQT) announces executive leadership changes as it prepares for the commercialization of its pipeline products. Scott Burrows will succeed John Smither as CFO effective April 1, 2021, after Smither's retirement. Burrows has 20 years of finance experience in the biopharmaceutical industry. Corey Padovano has been appointed Vice President of Sales, bringing 20 years of leadership experience. Sean Brugger joins as Executive Director of Field Medical Affairs, focused on scientific communications. These changes aim to enhance Arcutis' growth as it approaches its first New Drug Application.

Arcutis Biotherapeutics announced the enrollment of the first patient in a Phase 2a trial for ARQ-252, a selective JAK1 inhibitor, as a potential treatment for vitiligo, affecting approximately 1.3 million U.S. patients. This double-blind, vehicle-controlled study will evaluate ARQ-252 in combination with narrowband UVB therapy in about 500 subjects. The primary endpoint is ≥ 75% improvement in facial vitiligo area at week 24. Results are expected in the second half of 2023, aiming to provide better efficacy for patients dissatisfied with current off-label treatments.

Arcutis Biotherapeutics (Nasdaq: ARQT) announced new data for roflumilast cream, focusing on long-term safety and efficacy outcomes in adults with chronic plaque psoriasis. The presentations at the Innovations in Dermatology virtual conference highlighted results from a Phase 2 long-term safety study and the Phase 3 studies' positive topline data. The cream aims to address limitations of existing treatments by offering a favorable profile for chronic use. The company plans to submit a New Drug Application soon, potentially revolutionizing treatment standards for various dermatological conditions.