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Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is a commercial-stage medical dermatology company based in Westlake Village, California, specializing in developing and commercializing treatments for dermatological diseases. Founded in 2016, Arcutis leverages recent advances in immunology and inflammation to create differentiated therapies targeting immune-mediated dermatological conditions.
Arcutis' lead product, ZORYVE (roflumilast) cream, is a topical treatment for plaque psoriasis and atopic dermatitis. The company has recently launched ZORYVE topical foam for seborrheic dermatitis and scalp psoriasis. Both formulations utilize roflumilast, a potent and selective phosphodiesterase-4 (PDE4) inhibitor that has shown significant improvement in clinical trials.
Arcutis is also advancing its pipeline with ARQ-252, a selective topical small molecule inhibitor of janus kinase type 1 for hand eczema, and ARQ-255 for alopecia areata. The company champions meaningful innovation to address the urgent needs of patients living with chronic, immune-mediated skin conditions, aiming to improve treatment options and patient outcomes.
In recent developments, Arcutis has been actively participating in industry conferences, securing strategic collaborations, and expanding its workforce. The company's financial health is robust, with a strong cash position bolstered by a recent public offering and a strategic licensing agreement in Japan. Arcutis continues to focus on long-term growth and innovation, with multiple ongoing clinical programs targeting various inflammatory dermatological conditions.
For more information, visit www.arcutis.com or follow Arcutis on LinkedIn, Facebook, Instagram, and X.
Arcutis Biotherapeutics (Nasdaq: ARQT) has announced the enrollment of the first subject in a Phase 1b study for ARQ-255, a new topical JAK1 inhibitor designed for alopecia areata treatment. This formulation utilizes proprietary 4D technology to deliver the drug deep into the skin, targeting the hair follicle's inflammation. Alopecia areata affects approximately 1 in 500 adults, causing sudden hair loss and emotional distress. The study will focus on the safety and tolerability of ARQ-255 in healthy volunteers and those with patchy alopecia areata.
On December 1, 2022, MyHealthTeam launched MySebDermTeam, a dedicated online community for individuals living with seborrheic dermatitis, supported by Arcutis Biotherapeutics. The initiative aims to enhance diagnosis and treatment awareness as 5% of the population is affected by this condition, which is often under-diagnosed. A recent survey revealed it takes an average of 3.6 years for patients to seek care. The platform will offer educational resources including expert interviews and a symptom tracking guide to improve patient outcomes.
Arcutis Biotherapeutics (Nasdaq: ARQT) published positive Phase 2b trial results for roflumilast cream 0.3% in treating chronic plaque psoriasis, focusing on patient-reported outcomes. The data revealed significant reductions in itch by Week 2 compared to a vehicle. Patients using roflumilast experienced notable improvements in itch-related sleep loss during Weeks 6 to 12. This cream is a selective phosphodiesterase-4 inhibitor, highlighting its rapid effectiveness. The study was published in the American Journal of Clinical Dermatology, reaffirming roflumilast's role in managing plaque psoriasis.
Arcutis Biotherapeutics (Nasdaq: ARQT) has successfully added its drug ZORYVE (roflumilast) cream 0.3% to Express Scripts’ national formularies, effective November 18, 2022. This non-steroidal cream is the first topical PDE4 inhibitor approved for plaque psoriasis, providing access to over 26 million commercially insured patients in the U.S. The company launched ZORYVE on August 10, 2022, with a focus on affordability through responsible pricing and patient assistance programs. CEO Frank Watanabe highlighted the company's commitment to increasing access through further payer engagement.
Arcutis Biotherapeutics (Nasdaq: ARQT) announced positive topline results from its INTEGUMENT-1 Phase 3 trial for roflumilast cream 0.15% in treating mild to moderate atopic dermatitis. The primary endpoint was met, with 32.0% achieving IGA Success compared to 15.2% for the vehicle (P<0.0001). Key results include 43.2% achieving EASI-75 and 33.6% reporting reduced itch by Week 4. Roflumilast cream demonstrated a favorable safety profile, with minimal adverse events. Topline results from the INTEGUMENT-2 trial are expected by year-end.
Arcutis Biotherapeutics announced positive results from the INTEGUMENT-1 pivotal Phase 3 trial of its roflumilast cream 0.15%, targeting mild to moderate atopic dermatitis in patients aged six years and older. The treatment met its primary endpoint, with 32.0% of participants achieving Investigator Global Assessment (IGA) Success compared to 15.2% with vehicle (P<0.0001). Secondary endpoints showed 43.2% achieved EASI-75, and 33.6% reported meaningful itch reduction by Week 4. Roflumilast cream exhibited a favorable safety profile, with low adverse event rates. Results from the INTEGUMENT-2 trial are expected by year-end.
Arcutis Biotherapeutics (Nasdaq: ARQT) announced its participation in the Guggenheim 4th Annual Immunology and Neurology Day investor conference. The fireside chat is scheduled for November 15, 2022, at 10:45 a.m. ET. Investors can access the webcast through the Company’s website.
Arcutis focuses on addressing needs in immuno-dermatology through innovative therapies targeting conditions like psoriasis and dermatitis.
Arcutis Biotherapeutics reported third-quarter results with net revenues of $0.7 million from the launch of ZORYVE for plaque psoriasis in August 2022. The company achieved coverage for ZORYVE from a leading pharmacy benefit manager and a national health plan. It completed the enrollment for two pivotal Phase 3 trials for atopic dermatitis, with topline data expected by year-end. Additionally, Arcutis acquired Ducentis BioTherapeutics, enhancing its pipeline. As of September 30, 2022, the company holds approximately $480 million in cash and equivalents.
Arcutis Biotherapeutics (Nasdaq: ARQT) announced a conference call and webcast on November 8, 2022, at 5:00 p.m. ET to discuss its Q3 2022 financial results. The press release will be available after U.S. market close on the same day. Arcutis specializes in developing innovative therapies for immune-mediated dermatological diseases, utilizing a robust development platform with multiple clinical programs targeting conditions like scalp psoriasis and atopic dermatitis. For more details, visit www.arcutis.com.
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