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Arcutis Biotherapeutics, Inc. (ARQT) is a leader in developing innovative topical therapies for immune-mediated skin conditions. This page provides investors and medical professionals with essential updates on FDA approvals, clinical trial progress, and strategic initiatives shaping the future of dermatological care.
Access authoritative information about ARQT's non-steroidal treatments for conditions including atopic dermatitis and plaque psoriasis. Our curated news collection features regulatory milestones, research developments, and market analyses to help stakeholders track the company's progress in addressing unmet medical needs.
Key updates include new product launches, clinical trial results, partnership announcements, and scientific presentations. All content is verified through primary sources to ensure accuracy and compliance with financial disclosure standards.
Bookmark this page for streamlined access to Arcutis' latest advancements in immuno-dermatology. Check regularly for updates on pipeline developments and peer-reviewed research findings that demonstrate the company's commitment to transforming skin disease treatment.
Arcutis Biotherapeutics announced the publication of positive results from two pivotal Phase 3 trials (INTEGUMENT-1 and -2) for ZORYVE® (roflumilast) cream 0.15% in the Journal of American Medical Association Dermatology. The trials evaluated the efficacy and safety of ZORYVE cream as a once-daily, steroid-free treatment for mild to moderate atopic dermatitis (AD) in adults and children aged 6 and older.
Key findings include:
- 31% of patients achieved Investigator Global Assessment Success at Week 4 vs 14% for vehicle
- Rapid improvement in itch within 24 hours of first application
- Over 30% achieved Worst Itch-Numeric Rating Scale Success at Week 4
- More than 40% achieved a 75% reduction in Eczema Area and Severity Index score at Week 4
- ZORYVE cream demonstrated a favorable safety and tolerability profile
Arcutis Biotherapeutics (Nasdaq: ARQT), a commercial-stage biopharmaceutical company specializing in immuno-dermatology innovations, has granted 37,000 restricted stock units to three newly hired employees. The Compensation Committee approved these awards under the company's 2022 Inducement Plan, with a grant date of September 3, 2024. This action complies with Nasdaq Listing Rule 5635(c)(4), serving as an inducement for new employees joining Arcutis.
The restricted stock units have a four-year vesting schedule, with 25% vesting on each annual anniversary of the vesting commencement date. Vesting is contingent upon continuous employment with Arcutis. This disclosure aligns with Nasdaq Listing Rule 5635(c)(4) requirements.
Arcutis Biotherapeutics (Nasdaq: ARQT) has completed enrollment for its Phase 1b study of ARQ-255, a topical JAK1 inhibitor for alopecia areata. The study, involving 44 participants, aims to evaluate the safety, tolerability, pharmacodynamics, and pharmacokinetics of ARQ-255 in healthy adults and those with patchy alopecia areata. ARQ-255 utilizes Arcutis' proprietary Deep Dermal Drug Delivery (4D) technology to target inflammation at the hair follicle base. This innovation addresses a significant unmet need, as alopecia areata affects approximately 1 in 500 people with no FDA-approved topical treatments currently available. Results from this first-in-human study are expected in the first half of 2025, potentially advancing treatment options for this immune-mediated skin condition.
Arcutis Biotherapeutics (NASDAQ: ARQT) announced positive long-term results for roflumilast cream 0.05% in treating mild to moderate atopic dermatitis in children aged 2 to 5. The INTEGUMENT-OLE study showed durable efficacy and a favorable safety profile over 56 weeks of treatment. Key findings include:
- 71.9% of participants achieved EASI-75 after 56 weeks
- 53.8% achieved vIGA-AD success at 56 weeks
- No new safety signals observed
- Low incidence of adverse events, mostly mild to moderate
Arcutis plans to submit a supplemental New Drug Application (sNDA) to the FDA in Q1 2025 for roflumilast cream 0.05% for AD treatment in children aged 2-5 years.
Arcutis Biotherapeutics (Nasdaq: ARQT), a commercial-stage biopharmaceutical company specializing in immuno-dermatology innovations, has announced its participation in the Morgan Stanley 22nd Annual Global Healthcare Conference. The company's management will engage in a fireside chat on Thursday, September 5, 2024, at 1:50 pm ET.
Interested parties can access the webcast through the 'Events' section of Arcutis' website. A replay of the presentation will remain available on the company's website for 180 days following the conference, providing extended access to investors and stakeholders unable to attend the live event.
Arcutis Biotherapeutics (ARQT) reported strong Q2 2024 financial results, with net product revenues of $30.9M for the ZORYVE® franchise, showing a 547% increase year-over-year and 43% quarter-over-quarter growth. The company saw improved gross-to-net (GTN) performance, now in the high 50% range.
Key highlights include:
- Entered a co-promotion agreement with Kowa Pharmaceuticals America to expand ZORYVE's reach
- Submitted an sNDA for ZORYVE foam for scalp and body psoriasis
- Amended $200M term-loan for better financial flexibility
- Launched ZORYVE cream for atopic dermatitis in late July
Arcutis reported a net loss of $52.3M for Q2 2024, with cash and equivalents of $363.1M as of June 30, 2024. The company continues to focus on commercial growth and pipeline development in immuno-dermatology.
Arcutis Biotherapeutics reported strong Q2 2024 financial results, with net product revenues of $30.9M for the ZORYVE franchise, representing a 547% increase year-over-year and 43% growth quarter-over-quarter. The company saw improved gross-to-net (GTN) margins, now in the high 50% range. Arcutis entered a co-promotion agreement with Kowa Pharmaceuticals to expand ZORYVE's reach in primary care and pediatric offices. They also submitted an sNDA for ZORYVE foam for scalp and body psoriasis treatment. The company amended its $200M term-loan, improving financial flexibility. Despite strong sales growth, Arcutis reported a net loss of $52.3M for Q2 2024, with cash and equivalents of $363.1M as of June 30, 2024.
Arcutis Biotherapeutics (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on immuno-dermatology innovations, has reported the grant of 38,000 restricted stock units to four newly hired employees. The awards were approved by the Compensation Committee of Arcutis' Board of Directors under the company's 2022 Inducement Plan, with a grant date of August 1, 2024.
These stock units are designed as an inducement for new employees joining Arcutis, in compliance with Nasdaq Listing Rule 5635(c)(4). The restricted stock units have a four-year vesting schedule, with 25% vesting on each annual anniversary of the vesting commencement date, contingent on continuous employment with Arcutis.
Arcutis Biotherapeutics (Nasdaq: ARQT), a commercial-stage biopharmaceutical company specializing in immuno-dermatology innovations, has announced its plans to release second quarter 2024 financial results on August 14, 2024. The company will disclose its financial performance and provide a business update after the U.S. financial markets close on that day. Additionally, Arcutis will host a conference call and webcast at 4:30 p.m. ET to discuss the results. Investors and interested parties can access the live webcast and presentation materials through the 'Events' section of the company's website. An archived version of the webcast will be made available on the Arcutis investor website following the conference call.
Arcutis Biotherapeutics (Nasdaq: ARQT) has announced a co-promotion agreement with Kowa Pharmaceuticals America for ZORYVE® (roflumilast). This partnership will leverage Kowa's 200-person primary care sales force to promote ZORYVE cream and foam to primary care practitioners and pediatricians for all FDA-approved indications. The agreement aims to expand ZORYVE's total addressable market, providing access to a significant portion of the 7.4 million patients treated outside dermatology offices.
Key points of the agreement include:
- 5-year term with Kowa promoting ZORYVE in priority position
- Arcutis retains responsibility for manufacturing and dermatology sales
- Arcutis will recognize all revenue and pay Kowa a commission on sales
- Expected to drive incremental revenue while maintaining Arcutis' focus on dermatology
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