Arcutis Biotherapeutics reports company developments as a commercial-stage biopharmaceutical company focused on immuno-dermatology and medical dermatology. Its recurring updates center on ZORYVE (roflumilast) cream and foam, a topical PDE4 inhibitor portfolio used across inflammatory skin diseases including plaque psoriasis, atopic dermatitis, and seborrheic dermatitis.
Company news commonly covers ZORYVE net product revenue, demand trends for branded non-steroidal topical treatments, clinical data from dermatology studies, FDA submissions tied to potential label expansion, medical-meeting presentations, guideline references, sales-force and commercial updates, conference participation, and equity grants made under Nasdaq inducement-grant rules.
Arcutis Biotherapeutics (Nasdaq: ARQT) and Padagis have agreed to stay their ongoing patent litigation regarding ZORYVE® cream 0.3%. The joint stipulation, filed in the U.S. District Court for the District of Delaware on April 2, 2025, will vacate all calendared dates and trial.
Under the agreement, Padagis must report any FDA correspondence regarding their ANDA for a potential generic alternative to ZORYVE. The parties agreed to extend the 30-month Hatch-Waxman stay of regulatory approval by one day for every day the litigation is stayed from March 24, 2025.
ZORYVE, protected by patents until at least 2037, is indicated for topical treatment of plaque psoriasis in patients 6 years and older. The company maintains confidence in their patent portfolio and will continue defending their intellectual property rights if the stay is lifted.
Arcutis Biotherapeutics (Nasdaq: ARQT), a commercial-stage biopharmaceutical company specializing in immuno-dermatology innovations, has announced its participation in the 24th Annual Needham Virtual Healthcare Conference.
The company will engage in a fireside chat on Tuesday, April 8, 2025, at 11:00 am EDT. The conference is scheduled to run from April 7-10, 2025. Interested parties can access the webcast through the 'Events' section of Arcutis' website, with the recording remaining available for 180 days after the conference.
Arcutis Biotherapeutics (ARQT) presented new data from Phase 3 trials at the 2025 American Academy of Dermatology Meeting, showcasing results for ZORYVE® treatments in psoriasis and atopic dermatitis (AD).
The INTEGUMENT 1-2 trials (n=1,337) demonstrated positive efficacy of ZORYVE cream 0.15% in AD patients with prior inadequate response to conventional treatments. Over 91% of participants reported no or mild application site sensation, and ≥97% showed no or minimal irritation.
The ARRECTOR trial revealed significant improvements in patient-reported outcomes for ZORYVE foam 0.3% in scalp and body psoriasis, showing enhanced quality of life across 23-component Scalpdex assessment during the eight-week study period.
- AD affects ~26 million adults and children in the US
- Psoriasis impacts ~9 million US adults and children, with over half experiencing scalp involvement
Arcutis Biotherapeutics (Nasdaq: ARQT) has announced the grant of 27,000 restricted stock units to three newly hired employees. The grants were approved by the company's Compensation Committee and issued under the Arcutis Biotherapeutics 2022 Inducement Plan on March 3, 2025.
The restricted stock units feature a four-year vesting schedule, with 25% vesting annually on each anniversary of the vesting commencement date. Continued employment with Arcutis is required for vesting. The grants were made as employment inducements in compliance with Nasdaq Listing Rule 5635(c)(4).
Arcutis Biotherapeutics (Nasdaq: ARQT) will present two significant posters at the 2025 American Academy of Dermatology (AAD) annual meeting in Orlando from March 7-11, 2025. The first poster will showcase pooled data from Phase 3 INTEGUMENT trials, demonstrating the safety and tolerability of ZORYVE® cream 0.15% in atopic dermatitis patients aged six and above who previously had inadequate response to topical treatments including steroids.
The second presentation will feature results from the Phase 3 ARRECTOR trial, highlighting improvements in patient-related outcomes using ZORYVE® foam 0.3% for individuals over 12 years with scalp and body psoriasis. Additionally, Arcutis will host educational sessions on Culturally Conscious Dermatology™ at their booth, led by Dr. Candrice Heath, scheduled for March 7 and 8, 2025.
Arcutis Biotherapeutics (ARQT) announced FDA's acceptance of a supplemental New Drug Application (sNDA) for ZORYVE cream 0.05% to treat mild to moderate atopic dermatitis in children aged 2-5 years. The FDA set a PDUFA target date of October 13, 2025.
The application is supported by positive results from the INTEGUMENT-PED Phase 3 trial of 652 children. Key findings showed that 25.4% of ZORYVE-treated children achieved vIGA-AD Success at Week 4, compared to 10.7% for vehicle control (P0.0001). The treatment demonstrated rapid itch reduction, with over one-third of children achieving a four-point reduction in WI-NRS at Week 4.If approved, ZORYVE cream will provide a new treatment option for approximately 1.8 million children aged 2-5 with atopic dermatitis in the United States. The drug showed a favorable safety profile consistent with results in adults and older pediatric subjects.
Arcutis Biotherapeutics (ARQT) reported strong Q4 2024 financial results, with ZORYVE® net product revenue reaching $69.4 million, a 413% increase year-over-year and 55% increase quarter-over-quarter. Full-year 2024 ZORYVE revenue was $166.5 million, up 471% from 2023.
ZORYVE has become the most prescribed branded non-steroidal topical treatment across three major inflammatory skin conditions in the US, with over 360,000 prescriptions filled for cream 0.3% and 246,000 for foam formulation. The company submitted an sNDA for ZORYVE cream 0.05% for atopic dermatitis in children ages 2-5.
Q4 2024 financial highlights include total revenues of $71.4 million and a reduced net loss of $10.8 million ($0.09 per share). The company ended 2024 with $228.6 million in cash and equivalents, and made a $100 million partial debt prepayment with re-draw capability.
Arcutis Biotherapeutics (ARQT) announced positive results from the INTEGUMENT-PED phase 3 trial of ZORYVE® (roflumilast) cream 0.05% for treating mild to moderate atopic dermatitis in children aged 2-5 years. The trial, involving 652 children, demonstrated significant improvements across all primary and secondary efficacy endpoints.
Key results include: 25.4% of treated children achieved vIGA-AD Success versus 10.7% for vehicle (P0.0001); 39.4% achieved EASI-75 compared to 20.6% for vehicle; and improvement in itch was observed within 24 hours. The treatment was well-tolerated with low incidence of adverse events, mainly including upper respiratory tract infection, diarrhea, and vomiting.The company has submitted a supplemental New Drug Application (sNDA) to the FDA, targeting approximately 1.8 million children aged 2-5 with atopic dermatitis in the US who receive topical treatment.
Arcutis Biotherapeutics (Nasdaq: ARQT), a commercial-stage biopharmaceutical company specializing in immuno-dermatology innovations, has announced its upcoming participation in the TD Cowen 45th Annual Health Care Conference. The company will engage in a fireside chat scheduled for Tuesday, March 4, 2025, at 9:50 am EST.
The conference is set to take place from March 3-5, 2025. Interested parties can access the webcast through the 'Events' section of Arcutis' website, with the recording remaining available for 180 days after the conference.
Arcutis Biotherapeutics (ARQT) has announced the grant of 62,000 restricted stock units to eight newly hired employees. The awards were approved by the company's Compensation Committee and granted under the Arcutis Biotherapeutics 2022 Inducement Plan, with a grant date of February 3, 2025. The stock units are designed as an employment inducement in compliance with Nasdaq Listing Rule 5635(c)(4).
The restricted stock units feature a four-year vesting schedule, with 25% vesting occurring on each annual anniversary of the vesting commencement date. Continued employment with Arcutis is required for vesting eligibility.