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About Arcutis Biotherapeutics, Inc. (ARQT)
Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is a commercial-stage biopharmaceutical company dedicated to revolutionizing the treatment of immune-mediated dermatological diseases through meaningful innovation. Headquartered in Westlake Village, California, Arcutis focuses on developing and commercializing therapies that address persistent treatment challenges in dermatology, offering solutions that are safe, effective, and suitable for long-term use.
Core Business and Product Portfolio
Arcutis leverages its proprietary dermatology development platform to create differentiated therapies targeting biologically validated pathways. The company’s flagship product, ZORYVE® (roflumilast), is a next-generation topical phosphodiesterase-4 (PDE4) inhibitor available in both cream and foam formulations. ZORYVE is FDA-approved for multiple indications, including:
- Plaque Psoriasis: A chronic inflammatory skin condition affecting millions of adults and children.
- Atopic Dermatitis (AD): A relapsing inflammatory skin disease characterized by intense itching and redness, now approved for both adults and pediatric patients as young as 6 years old, with an additional formulation under FDA review for children aged 2 to 5 years.
- Seborrheic Dermatitis: A common, recurrent inflammatory skin condition, for which ZORYVE foam offers a steroid-free, once-daily treatment option.
These products are designed to overcome the limitations of traditional steroidal therapies by providing a safe, well-tolerated, and effective alternative that can be applied anywhere on the body for any duration.
Innovative Dermatology Pipeline
Arcutis continues to advance a robust pipeline of dermatology-focused therapies, including:
- ARQ-255: A topical suspension of ivarmacitinib, a selective JAK1 inhibitor, targeting alopecia areata by delivering the drug deep into the hair follicle.
- ARQ-234: A fusion protein acting as a checkpoint agonist of the CD200 receptor, under development as a potential biologic treatment for atopic dermatitis.
The company’s pipeline underscores its commitment to addressing unmet needs in dermatology by focusing on innovative, patient-centric solutions.
Market Position and Strategic Partnerships
Arcutis has established itself as a leader in medical dermatology, with ZORYVE recognized as the number one prescribed branded non-steroidal topical therapy in its categories. The company’s strategic co-promotion agreement with Kowa Pharmaceuticals America, Inc. expands its reach into primary care and pediatric settings, ensuring broader access to its therapies. Additionally, international collaborations, such as the Sato License Agreement, highlight its global ambitions.
Commitment to Patient-Centric Innovation
Arcutis is deeply committed to improving the lives of individuals living with chronic skin conditions. By prioritizing safety, tolerability, and efficacy, the company addresses the unique needs of patients and caregivers. Its products are formulated without irritants or sensitizing excipients, ensuring compatibility with sensitive skin and long-term use. Clinical trials consistently demonstrate rapid and durable efficacy, reinforcing Arcutis’ position as a trusted innovator in dermatology.
Conclusion
Arcutis Biotherapeutics, Inc. is redefining the standard of care in dermatology through its innovative therapies and unwavering commitment to solving persistent patient challenges. With a growing portfolio of FDA-approved products, a robust pipeline, and strategic market partnerships, Arcutis is poised to continue its significant impact on the field of immuno-dermatology.
Arcutis Biotherapeutics (Nasdaq: ARQT) reported third-quarter results on November 5, 2020, revealing a net loss of $38.2 million, equating to $1.01 per share. The company holds over $300 million in cash and equivalents, ensuring operational funding into 2022. Upcoming pivotal Phase 3 data for roflumilast cream in plaque psoriasis is expected in Q1 2021. Positive Phase 2 data for seborrheic dermatitis strengthens its pipeline, targeting a market of over 20 million patients in the U.S. R&D expenses surged to $32.7 million, largely due to new clinical trials.
Arcutis Biotherapeutics (Nasdaq: ARQT) has appointed Terrie Curran to its Board of Directors, effective Nov. 2, 2020, following the resignation of Alexander Asam. Curran brings over 20 years of experience in biopharmaceuticals and will aid in commercialization as Arcutis prepares for pivotal Phase 3 trial data and potential NDA submission for its lead product, topical roflumilast. This treatment aims to set a new standard for several inflammatory dermatological conditions. The company anticipates growth and innovation under Curran's leadership.
Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) announced positive results from its Phase 2 studies of roflumilast cream for plaque psoriasis and atopic dermatitis. The Phase 2b study demonstrated significant reduction in itch severity and related sleep loss, with 63% of patients achieving clinically meaningful itch reduction by week 12. In atopic dermatitis, although the primary endpoint did not reach statistical significance, notable improvements were recorded. Both studies reported roflumilast cream as safe and well-tolerated, supporting its potential as a leading topical treatment option.
Arcutis Biotherapeutics (Nasdaq: ARQT) announced positive outcomes from Phase 2 studies of roflumilast cream for treating atopic dermatitis and plaque psoriasis at the European Academy of Dermatology and Venereology (EADV) Virtual Congress and other conferences. Two oral presentations and one poster highlighted the cream’s effectiveness in improving itch severity and symptom burden. These findings were presented on October 29 and 31, 2020. The cream is positioned as a promising 'Best in Class' topical PDE4 inhibitor, addressing significant dermatological treatment gaps.
Arcutis Biotherapeutics has completed enrollment in its Phase 1/2b study of ARQ-252, a selective JAK1 inhibitor aimed at treating chronic hand eczema, a condition affecting over 8 million Americans. The trial's topline data is expected by mid-2021. ARQ-252's high selectivity for JAK1 may provide efficacy while minimizing side effects associated with other JAK inhibitors. The study involved 223 subjects assessing the safety and efficacy of different concentrations of the ARQ-252 cream. This research highlights the company's commitment to addressing the unmet needs in dermatological therapies.
Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) announced the completion of a public offering of 4,000,000 shares at $25.00 per share, raising gross proceeds of $100 million. Additionally, a private placement of 1,400,000 shares was made to OrbiMed Advisors, generating another $35 million. The offering's registration statement became effective on October 1, 2020. Goldman Sachs, Cowen, and Guggenheim are managing the public offering. Arcutis focuses on developing treatments for immune-mediated dermatological diseases, with its lead candidate targeting plaque psoriasis and other skin conditions.
Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) announced a public offering of 4,000,000 shares at $25.00 each, aiming for gross proceeds of $100 million. The offering includes a 30-day option for underwriters to purchase an additional 600,000 shares. Concurrently, Arcutis plans a private placement of 1,400,000 shares at the same price for gross proceeds of $35 million, contingent on the public offering's success. The public offering is expected to close on October 6, 2020. The company focuses on immuno-dermatology treatments and has a developing pipeline of therapies.
Arcutis Biotherapeutics (Nasdaq: ARQT) has completed enrollment in two pivotal Phase 3 trials (DERMIS-1 and DERMIS-2) for its topical roflumilast cream, a potential treatment for plaque psoriasis affecting about 8.6 million patients in the U.S. Topline results are expected in Q1 2021, with a New Drug Application (NDA) submission planned by year-end. Previous Phase 2 studies indicated significant improvements and a favorable safety profile for roflumilast. The cream's unique formulation aims to provide effective treatment without the trade-offs seen in existing therapies.
Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) announced its participation in the Cantor Fitzgerald Global Healthcare Conference 2020. The fireside chat presentation is scheduled for September 17, 2020, at 7:40 a.m. PT / 10:40 a.m. ET. This event focuses on the company’s developments in immune-mediated dermatological diseases. Interested parties can access the webcast through the company’s website, which will be available for replay for 30 days following the conference. Arcutis is committed to addressing unmet needs with its innovative therapies for dermatological conditions.
Arcutis Biotherapeutics has announced the advancement of its topical roflumilast cream to Phase 3 clinical trials for atopic dermatitis without conducting a Phase 2b trial following FDA discussions. Roflumilast cream, a selective PDE4 inhibitor, aims to offer a once-daily treatment option for approximately 20 million U.S. patients. Previous trials indicated its efficacy and tolerability are comparable to existing treatments. Topline data for plaque psoriasis trials is expected in early 2021, marking a significant step in developing innovative therapies for dermatological conditions.
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