Arcutis Biotherapeutics, Inc. - ARQT STOCK NEWS

Arcutis Biotherapeutics (Nasdaq: ARQT) announced a planned CFO transition, with David Topper retiring and Latha Vairavan, current VP and controller, taking over the position. The transition will be effective after the Q1 10-Q filing, with Topper providing support through May 15, 2025.

During his tenure since April 2024, Topper made significant contributions including renegotiating the company's debt facility with SLR Investment Corp, revamping investor relations strategy, and leading the transition to large accelerated filer status. Vairavan, who joined Arcutis in 2020, brings over 20 years of biotech industry finance experience, including 12 years at Amgen.

The company highlighted continued market momentum for their product ZORYVE® (roflumilast) in inflammatory skin conditions. Vairavan will focus on further commercialization efforts and maintaining the company's financial position.

Arcutis Biotherapeutics (Nasdaq: ARQT) has announced the grant of 35,000 restricted stock units to five newly hired employees. The grants were approved by the company's Compensation Committee and issued under the Arcutis Biotherapeutics 2022 Inducement Plan on April 1, 2025.

The restricted stock units feature a four-year vesting schedule, with 25% vesting annually on each anniversary of the vesting commencement date. Continuous employment is required for vesting. This grant was made as an employment inducement in compliance with Nasdaq Listing Rule 5635(c)(4).

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 (P<0.0001). 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.